Protocol Index	

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RESEARCH PRO00015423 INCB39110-206 IYER	

Types:      Research Oncology Treatment
Synonyms:  INCB, PRO, INCB39110, 39110, INCB-39110

Screening / Baseline	Repeat 1 time	Cycle length: 28 days	Day -28 to Day -1	Perform every 1 day x1		Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	LDH	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		☑	PREALBUMIN LEVEL	Interval: --	Occurrences: --		☑	LIPID PANEL	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		☑	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		☑	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --		☑	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --		☑	HEPATITIS C ANTIBODY	Interval: --	Occurrences: --		☑	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR WITH REFLEX TO HCV GENOTYPE	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Imaging
☑	CT SOFT TISSUE NECK W CONTRAST	Interval: --	Occurrences: --		☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --			Nursing Orders
☑	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		☑	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Vital signs  (blood pressure, heart rate, temperature)
		☑	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Height - Must be measured by provider (Patient cannot state)
		☑	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Weight - Must be measured by provider (Patient cannot state)
		☑	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-9984).  Triplicate ECGs will be performed during screening.
		☑	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical exam must be performed during screening period (Romberg's test)
		☑	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Indicate in progress note a review of the subject's current B lymphoma signs and symptoms (drenching night sweats, fevers GREATER than 101°F [38.3°C], chills, unexplained weight loss of over 10% of body mass over 6 months)
		☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Indicate in Progress note if Hepatomegaly is present.  If present, please include #mm below costal margin.
		☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Indicate in Progress note if Splenomegaly is present.  If present, please include #mm below costal margin
		☑	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Bone marrow biopsy - with basic pathology evaluation (no molecular testing, FISH, cytogenetics) - for research only, if one is not being performed as part of the patient's standard of care
					
Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	LDH	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		☑	PREALBUMIN LEVEL	Interval: --	Occurrences: --		☑	LIPID PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Nursing Orders
☑	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		☑	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Vital signs  (blood pressure, pulse, respiratory rate, body temperature, weight)
		☑	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical exam must be performed on this date
		☑	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Indicate in progress note a review of the subject's current B lymphoma signs and symptoms (drenching night sweats, fevers > 101°F [38.3°C], chills, unexplained weight loss of over 10% of body mass over 6 months)
		☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Hepatomegaly is present.  If present, please include #mm below costal margin.
		☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Splenomegaly is present.  If present, please include #mm below costal margin
		☑	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-8010).  Triplicate ECGs will be performed on C1/D1 before starting subject treatment.
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	o ANC GREATER than or EQUAL to 1.5 × 109/L. 
o Platelet count GREATER than or EQUAL to 75 × 109/L. 
o Hemoglobin GREATER than or EQUAL to 8.0 g/dL (transfusions are permitted to achieve required hemoglobin level). 
o Serum creatinine LESS than or EQUAL to 2.0 g/dL or measured or calculated creatinine clearance GREATER than or EQUAL to 30 mL/min by the Cockcroft-Gault Equation. 
o Aspartate aminotransferase (AST) and ALT LESS than or EQUAL to 2.5 × institutional upper limit of normal (ULN). 
o Bilirubin LESS than 2.0 × ULN unless bilirubin increase was due to Gilbert's disease. Further evaluation should be performed to confirm and document the origin of increase. 
o Prothrombin time (PT)/international normalized ratio (INR) LESS than 1.5 × ULN and activated partial thromboplastin time (aPTT) LESS than 1.5 × ULN.
			Nursing Orders
  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Chemistries:

AST and/or ALT GREATER than 3.0 × ULN 

Note: In subjects with bone metastasis-related elevations at baseline, contact sponsor to discuss clinical management and possible dose reductions. 	
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to Grade LESS than or EQUAL to 1 (unless approved otherwise by the medical monitor). 
Step 2: Restart INCB039110 at same dose. If assessed as related to INCB039110, restart at next lower dose. Monitor as clinically indicated. 

Hematology:

ANC LESS than or EQUAL to 1.0 × 109/L unless due to underlying disease 
o Platelet count is LESS than 60 × 109/L unless due to underlying disease 	
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to LESS than or EQUAL to Grade 1 or pretherapy baseline. 
Step 2: Restart INCB039110 at same dose; monitor as clinically indicated. 

Grade 4 ANC (LESS than 0.5 × 109/L) 
o GREATER than or EQUAL to Grade 3 ANC with an oral temperature of at least 38.5°C OR with GREATER than or EQUAL to Grade 3 infection. 
o Platelet count is LESS than 35 × 109/L 
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to LESS than or EQUAL to Grade 1. 
Step 2: Restart INCB039110 at same dose. If assessed as related to INCB039110, restart at next lower dose. Monitor as clinically indicated

Other toxicities: 

o Any Grade 1 or Grade 2 toxicity 
Continue study treatment and treat the toxicity; monitor as clinically indicated. 

o Any Grade 3 toxicity, if clinically significant and not manageable by supportive care 
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to LESS than or EQUAL to Grade 1. 
Step 2: Restart INCB039110 at same dose. If assessed as related to INCB039110, restart at next lower dose. Monitor as clinically indicated. 

o Any recurrent Grade 3 toxicity after 2 dose reductions 
Discontinue study drug administration and follow-up per Protocol. Exceptions require approval of sponsor. 

o Any other Grade 4 toxicity 
Discontinue study drug administration and follow-up per Protocol. Exceptions require approval of sponsor. 

Dose modifications of Ibrutinib:
o Grade 4 ANC (LESS than 0.5 × 109/L) for more than 7 days. 
o Grade 3 thrombocytopenia (LESS than 50 × 109/L) in the presence of clinically significant bleeding events. 
o Grade 4 thrombocytopenia (LESS than 25 × 109/L). 
o Grade 3 or 4 nausea, vomiting, or diarrhea if persistent, despite optimal antiemetic and/or antidiarrheal therapy. 
o Any other Grade 4 or unmanageable Grade 3 toxicity. 

For Grade 3 or 4 atrial fibrillation or persistent atrial fibrillation of any grade, the risks and benefits of ibrutinib treatment should be considered. 

Ibrutinib is metabolized in the liver. For subjects who develop mild liver impairment while on study (Child-Pugh Class A), the recommended dose reduction for ibrutinib is to a level of 280 mg daily (2 capsules). For subjects who develop moderate liver impairment while on study (Child-Pugh Class B), the recommended dose reduction is to a level of 140 mg daily (1 capsule). Subjects who develop severe hepatic impairment (Child-Pugh Class C) must withhold study drug

Toxicity Occurrence 	
Action to be Taken: 
First - Withhold study drug until recovery to Grade LESS than or EQUAL to 1 or baseline; may restart at original dose level. 
Second - Withhold study drug until recovery to Grade LESS than or EQUAL to 1 or baseline; may restart at 1 dose level lower (ie, 280 mg/day for 420 mg/day dose; 420 mg/day for 560 mg/day dose). 
Third - Withhold study drug until recovery to Grade LESS than or EQUAL to 1 or baseline; may restart at 1 dose level lower (ie, 140 mg/day for 420 mg/day dose; 280 mg/day for 560 mg/day dose). 
Fourth - Discontinue study drug.
				Day 8	Perform every 1 day x1		Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	LDH	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		☑	PREALBUMIN LEVEL	Interval: --	Occurrences: --		☑	LIPID PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Nursing Orders
☑	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		☑	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Vital signs  (blood pressure, pulse, respiratory rate, body temperature, weight)
		☑	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical exam must be performed on this date
		☑	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Indicate in progress note a review of the subject's current B lymphoma signs and symptoms (drenching night sweats, fevers > 101°F [38.3°C], chills, unexplained weight loss of over 10% of body mass over 6 months)
		☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Hepatomegaly is present.  If present, please include #mm below costal margin.
		☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Splenomegaly is present.  If present, please include #mm below costal margin
		☑	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-8010).  Triplicate ECGs will be performed predose and 2 hours  (+/- 15 minutes) after receiving INCB039110 on C1/D8
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 15	Perform every 1 day x1		Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	LDH	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		☑	PREALBUMIN LEVEL	Interval: --	Occurrences: --		☑	LIPID PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Nursing Orders
☑	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		☑	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Vital signs  (blood pressure, pulse, respiratory rate, body temperature, weight)
		☑	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical exam must be performed on this date
		☑	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Indicate in progress note a review of the subject's current B lymphoma signs and symptoms (drenching night sweats, fevers > 101°F [38.3°C], chills, unexplained weight loss of over 10% of body mass over 6 months)
		☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Hepatomegaly is present.  If present, please include #mm below costal margin.
		☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Splenomegaly is present.  If present, please include #mm below costal margin
		☑	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-8010).
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 28	Perform every 1 day x1		Nursing Orders
☑	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		☑	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Vital signs  (blood pressure, pulse, respiratory rate, body temperature, weight)
		☑	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical exam must be performed on this date
		☑	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Indicate in progress note a review of the subject's current B lymphoma signs and symptoms (drenching night sweats, fevers > 101°F [38.3°C], chills, unexplained weight loss of over 10% of body mass over 6 months)
		☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Hepatomegaly is present.  If present, please include #mm below costal margin.
		☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Splenomegaly is present.  If present, please include #mm below costal margin
		☑	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-8010).
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Cycle 2	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	LDH	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		☑	PREALBUMIN LEVEL	Interval: --	Occurrences: --		☑	LIPID PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Nursing Orders
☑	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		☑	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Vital signs  (blood pressure, pulse, respiratory rate, body temperature, weight)
		☑	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical exam must be performed on this date
		☑	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Indicate in progress note a review of the subject's current B lymphoma signs and symptoms (drenching night sweats, fevers > 101°F [38.3°C], chills, unexplained weight loss of over 10% of body mass over 6 months)
		☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Hepatomegaly is present.  If present, please include #mm below costal margin.
		☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Splenomegaly is present.  If present, please include #mm below costal margin
		☑	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-8010).
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Nursing Orders
☑	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Dose HOLD criteria for study drug:

o	Total bilirubin GREATER THAN 3.0 × ULN 
o	AST and/or ALT GREATER THAN 3.0 × ULN 
o	ALP GREATER THAN or EQUAL TO 2.5 × ULN 
o	ANC LESS THAN 1.0 × 109/L for subjects who enrolled with ANC GREATER THAN 1.5 × 109/L 
o	ANC LESS THAN 0.5 × 109/L for subjects who enrolled with ANC LESS THAN or EQUAL TO 1.5 × 109/L 
o	Platelet count is 50 to LESS THAN 75 × 109/L for subjects who enrolled with platelets GREATER THAN 100 × 109/L 
o	Platelet count is LESS THAN 50 × 109/L for subjects who enrolled with platelets LESS THAN or EQUAL TO 100 × 109/L 
o	Grade 4 ANC (LESS THAN 0.5 × 109/L) lasting 7 days 
o	GREATER THAN or EQUAL to Grade 3 ANC with an oral temperature of at least 38.5°C OR with GREATER THAN or EQUAL TO Grade 3 infection 
o	Platelet count is LESS THAN 50 × 109/L for subjects who enrolled with platelets GREATER THAN 100 × 109/L 
o	Platelet count is LESS THAN 25 × 109/L for subjects who enrolled with platelets LESS THAN or EQUAL TO 100 × 109/L 
o	Diarrhea/colitis (GREATER THAN or EQUAL TO Grade 2)
o	Pneumonitis (Grade GREATER THAN or EQUAL TO 1) 
o	Skin toxicity (eg, rash, pruritus, etc, unless otherwise specified) (Grade 2-3) 
o	Exfoliative dermatitis (GREATER THAN or EQUAL TO Grade 1) 
o	Intestinal perforation (any grade) 
o	Pneumocystis jiroveci pneumonia infection 
o	CMV infection 
o	Varicella zoster infection
			Nursing Orders
  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Chemistries:

AST and/or ALT GREATER than 3.0 × ULN 

Note: In subjects with bone metastasis-related elevations at baseline, contact sponsor to discuss clinical management and possible dose reductions. 	
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to Grade LESS than or EQUAL to 1 (unless approved otherwise by the medical monitor). 
Step 2: Restart INCB039110 at same dose. If assessed as related to INCB039110, restart at next lower dose. Monitor as clinically indicated. 

Hematology:

ANC LESS than or EQUAL to 1.0 × 109/L unless due to underlying disease 
o Platelet count is LESS than 60 × 109/L unless due to underlying disease 	
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to LESS than or EQUAL to Grade 1 or pretherapy baseline. 
Step 2: Restart INCB039110 at same dose; monitor as clinically indicated. 

Grade 4 ANC (LESS than 0.5 × 109/L) 
o GREATER than or EQUAL to Grade 3 ANC with an oral temperature of at least 38.5°C OR with GREATER than or EQUAL to Grade 3 infection. 
o Platelet count is LESS than 35 × 109/L 
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to LESS than or EQUAL to Grade 1. 
Step 2: Restart INCB039110 at same dose. If assessed as related to INCB039110, restart at next lower dose. Monitor as clinically indicated

Other toxicities: 

o Any Grade 1 or Grade 2 toxicity 
Continue study treatment and treat the toxicity; monitor as clinically indicated. 

o Any Grade 3 toxicity, if clinically significant and not manageable by supportive care 
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to LESS than or EQUAL to Grade 1. 
Step 2: Restart INCB039110 at same dose. If assessed as related to INCB039110, restart at next lower dose. Monitor as clinically indicated. 

o Any recurrent Grade 3 toxicity after 2 dose reductions 
Discontinue study drug administration and follow-up per Protocol. Exceptions require approval of sponsor. 

o Any other Grade 4 toxicity 
Discontinue study drug administration and follow-up per Protocol. Exceptions require approval of sponsor. 

Dose modifications of Ibrutinib:
o Grade 4 ANC (LESS than 0.5 × 109/L) for more than 7 days. 
o Grade 3 thrombocytopenia (LESS than 50 × 109/L) in the presence of clinically significant bleeding events. 
o Grade 4 thrombocytopenia (LESS than 25 × 109/L). 
o Grade 3 or 4 nausea, vomiting, or diarrhea if persistent, despite optimal antiemetic and/or antidiarrheal therapy. 
o Any other Grade 4 or unmanageable Grade 3 toxicity. 

For Grade 3 or 4 atrial fibrillation or persistent atrial fibrillation of any grade, the risks and benefits of ibrutinib treatment should be considered. 

Ibrutinib is metabolized in the liver. For subjects who develop mild liver impairment while on study (Child-Pugh Class A), the recommended dose reduction for ibrutinib is to a level of 280 mg daily (2 capsules). For subjects who develop moderate liver impairment while on study (Child-Pugh Class B), the recommended dose reduction is to a level of 140 mg daily (1 capsule). Subjects who develop severe hepatic impairment (Child-Pugh Class C) must withhold study drug

Toxicity Occurrence 	
Action to be Taken: 
First - Withhold study drug until recovery to Grade LESS than or EQUAL to 1 or baseline; may restart at original dose level. 
Second - Withhold study drug until recovery to Grade LESS than or EQUAL to 1 or baseline; may restart at 1 dose level lower (ie, 280 mg/day for 420 mg/day dose; 420 mg/day for 560 mg/day dose). 
Third - Withhold study drug until recovery to Grade LESS than or EQUAL to 1 or baseline; may restart at 1 dose level lower (ie, 140 mg/day for 420 mg/day dose; 280 mg/day for 560 mg/day dose). 
Fourth - Discontinue study drug.
				Day 3	Perform every 1 day x1		Nursing Orders
☑	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		☑	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Vital signs  (blood pressure, pulse, respiratory rate, body temperature, weight)
		☑	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical exam must be performed on this date
		☑	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Indicate in progress note a review of the subject's current B lymphoma signs and symptoms (drenching night sweats, fevers > 101°F [38.3°C], chills, unexplained weight loss of over 10% of body mass over 6 months)
		☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Hepatomegaly is present.  If present, please include #mm below costal margin.
		☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Splenomegaly is present.  If present, please include #mm below costal margin
		☑	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-8010).
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 4	Perform every 1 day x1		Nursing Orders
☑	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		☑	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Vital signs  (blood pressure, pulse, respiratory rate, body temperature, weight)
		☑	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical exam must be performed on this date
		☑	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Indicate in progress note a review of the subject's current B lymphoma signs and symptoms (drenching night sweats, fevers > 101°F [38.3°C], chills, unexplained weight loss of over 10% of body mass over 6 months)
		☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Hepatomegaly is present.  If present, please include #mm below costal margin.
		☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Splenomegaly is present.  If present, please include #mm below costal margin
		☑	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-8010).
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 5	Perform every 1 day x1		Nursing Orders
☑	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		☑	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Vital signs  (blood pressure, pulse, respiratory rate, body temperature, weight)
		☑	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical exam must be performed on this date
		☑	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Indicate in progress note a review of the subject's current B lymphoma signs and symptoms (drenching night sweats, fevers > 101°F [38.3°C], chills, unexplained weight loss of over 10% of body mass over 6 months)
		☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Hepatomegaly is present.  If present, please include #mm below costal margin.
		☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Splenomegaly is present.  If present, please include #mm below costal margin
		☑	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-8010).
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Cycle 3	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	LDH	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		☑	PREALBUMIN LEVEL	Interval: --	Occurrences: --		☑	LIPID PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Nursing Orders
☑	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		☑	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Vital signs  (blood pressure, pulse, respiratory rate, body temperature, weight)
		☑	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical exam must be performed on this date
		☑	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Indicate in progress note a review of the subject's current B lymphoma signs and symptoms (drenching night sweats, fevers > 101°F [38.3°C], chills, unexplained weight loss of over 10% of body mass over 6 months)
		☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Hepatomegaly is present.  If present, please include #mm below costal margin.
		☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Splenomegaly is present.  If present, please include #mm below costal margin
		☑	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-8010).
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Nursing Orders
☑	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Dose HOLD criteria for study drug:

o	Total bilirubin GREATER THAN 3.0 × ULN 
o	AST and/or ALT GREATER THAN 3.0 × ULN 
o	ALP GREATER THAN or EQUAL TO 2.5 × ULN 
o	ANC LESS THAN 1.0 × 109/L for subjects who enrolled with ANC GREATER THAN 1.5 × 109/L 
o	ANC LESS THAN 0.5 × 109/L for subjects who enrolled with ANC LESS THAN or EQUAL TO 1.5 × 109/L 
o	Platelet count is 50 to LESS THAN 75 × 109/L for subjects who enrolled with platelets GREATER THAN 100 × 109/L 
o	Platelet count is LESS THAN 50 × 109/L for subjects who enrolled with platelets LESS THAN or EQUAL TO 100 × 109/L 
o	Grade 4 ANC (LESS THAN 0.5 × 109/L) lasting 7 days 
o	GREATER THAN or EQUAL to Grade 3 ANC with an oral temperature of at least 38.5°C OR with GREATER THAN or EQUAL TO Grade 3 infection 
o	Platelet count is LESS THAN 50 × 109/L for subjects who enrolled with platelets GREATER THAN 100 × 109/L 
o	Platelet count is LESS THAN 25 × 109/L for subjects who enrolled with platelets LESS THAN or EQUAL TO 100 × 109/L 
o	Diarrhea/colitis (GREATER THAN or EQUAL TO Grade 2)
o	Pneumonitis (Grade GREATER THAN or EQUAL TO 1) 
o	Skin toxicity (eg, rash, pruritus, etc, unless otherwise specified) (Grade 2-3) 
o	Exfoliative dermatitis (GREATER THAN or EQUAL TO Grade 1) 
o	Intestinal perforation (any grade) 
o	Pneumocystis jiroveci pneumonia infection 
o	CMV infection 
o	Varicella zoster infection
			Nursing Orders
  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Chemistries:

AST and/or ALT GREATER than 3.0 × ULN 

Note: In subjects with bone metastasis-related elevations at baseline, contact sponsor to discuss clinical management and possible dose reductions. 	
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to Grade LESS than or EQUAL to 1 (unless approved otherwise by the medical monitor). 
Step 2: Restart INCB039110 at same dose. If assessed as related to INCB039110, restart at next lower dose. Monitor as clinically indicated. 

Hematology:

ANC LESS than or EQUAL to 1.0 × 109/L unless due to underlying disease 
o Platelet count is LESS than 60 × 109/L unless due to underlying disease 	
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to LESS than or EQUAL to Grade 1 or pretherapy baseline. 
Step 2: Restart INCB039110 at same dose; monitor as clinically indicated. 

Grade 4 ANC (LESS than 0.5 × 109/L) 
o GREATER than or EQUAL to Grade 3 ANC with an oral temperature of at least 38.5°C OR with GREATER than or EQUAL to Grade 3 infection. 
o Platelet count is LESS than 35 × 109/L 
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to LESS than or EQUAL to Grade 1. 
Step 2: Restart INCB039110 at same dose. If assessed as related to INCB039110, restart at next lower dose. Monitor as clinically indicated

Other toxicities: 

o Any Grade 1 or Grade 2 toxicity 
Continue study treatment and treat the toxicity; monitor as clinically indicated. 

o Any Grade 3 toxicity, if clinically significant and not manageable by supportive care 
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to LESS than or EQUAL to Grade 1. 
Step 2: Restart INCB039110 at same dose. If assessed as related to INCB039110, restart at next lower dose. Monitor as clinically indicated. 

o Any recurrent Grade 3 toxicity after 2 dose reductions 
Discontinue study drug administration and follow-up per Protocol. Exceptions require approval of sponsor. 

o Any other Grade 4 toxicity 
Discontinue study drug administration and follow-up per Protocol. Exceptions require approval of sponsor. 

Dose modifications of Ibrutinib:
o Grade 4 ANC (LESS than 0.5 × 109/L) for more than 7 days. 
o Grade 3 thrombocytopenia (LESS than 50 × 109/L) in the presence of clinically significant bleeding events. 
o Grade 4 thrombocytopenia (LESS than 25 × 109/L). 
o Grade 3 or 4 nausea, vomiting, or diarrhea if persistent, despite optimal antiemetic and/or antidiarrheal therapy. 
o Any other Grade 4 or unmanageable Grade 3 toxicity. 

For Grade 3 or 4 atrial fibrillation or persistent atrial fibrillation of any grade, the risks and benefits of ibrutinib treatment should be considered. 

Ibrutinib is metabolized in the liver. For subjects who develop mild liver impairment while on study (Child-Pugh Class A), the recommended dose reduction for ibrutinib is to a level of 280 mg daily (2 capsules). For subjects who develop moderate liver impairment while on study (Child-Pugh Class B), the recommended dose reduction is to a level of 140 mg daily (1 capsule). Subjects who develop severe hepatic impairment (Child-Pugh Class C) must withhold study drug

Toxicity Occurrence 	
Action to be Taken: 
First - Withhold study drug until recovery to Grade LESS than or EQUAL to 1 or baseline; may restart at original dose level. 
Second - Withhold study drug until recovery to Grade LESS than or EQUAL to 1 or baseline; may restart at 1 dose level lower (ie, 280 mg/day for 420 mg/day dose; 420 mg/day for 560 mg/day dose). 
Third - Withhold study drug until recovery to Grade LESS than or EQUAL to 1 or baseline; may restart at 1 dose level lower (ie, 140 mg/day for 420 mg/day dose; 280 mg/day for 560 mg/day dose). 
Fourth - Discontinue study drug.
				Day 3	Perform every 1 day x1		Nursing Orders
☑	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		☑	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Vital signs  (blood pressure, pulse, respiratory rate, body temperature, weight)
		☑	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical exam must be performed on this date
		☑	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Indicate in progress note a review of the subject's current B lymphoma signs and symptoms (drenching night sweats, fevers > 101°F [38.3°C], chills, unexplained weight loss of over 10% of body mass over 6 months)
		☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Hepatomegaly is present.  If present, please include #mm below costal margin.
		☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Splenomegaly is present.  If present, please include #mm below costal margin
		☑	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-8010).
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 4	Perform every 1 day x1		Nursing Orders
☑	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		☑	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Vital signs  (blood pressure, pulse, respiratory rate, body temperature, weight)
		☑	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical exam must be performed on this date
		☑	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Indicate in progress note a review of the subject's current B lymphoma signs and symptoms (drenching night sweats, fevers > 101°F [38.3°C], chills, unexplained weight loss of over 10% of body mass over 6 months)
		☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Hepatomegaly is present.  If present, please include #mm below costal margin.
		☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Splenomegaly is present.  If present, please include #mm below costal margin
		☑	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-8010).
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 5	Perform every 1 day x1		Nursing Orders
☑	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		☑	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Vital signs  (blood pressure, pulse, respiratory rate, body temperature, weight)
		☑	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical exam must be performed on this date
		☑	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Indicate in progress note a review of the subject's current B lymphoma signs and symptoms (drenching night sweats, fevers > 101°F [38.3°C], chills, unexplained weight loss of over 10% of body mass over 6 months)
		☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Hepatomegaly is present.  If present, please include #mm below costal margin.
		☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Splenomegaly is present.  If present, please include #mm below costal margin
		☑	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-8010).
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 15-21	Perform every 1 day x1		Imaging
☑	CT SOFT TISSUE NECK W CONTRAST	Interval: --	Occurrences: --		☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --					
Cycle 4	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	LDH	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		☑	PREALBUMIN LEVEL	Interval: --	Occurrences: --		☑	LIPID PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Nursing Orders
☑	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		☑	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Vital signs  (blood pressure, pulse, respiratory rate, body temperature, weight)
		☑	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical exam must be performed on this date
		☑	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Indicate in progress note a review of the subject's current B lymphoma signs and symptoms (drenching night sweats, fevers > 101°F [38.3°C], chills, unexplained weight loss of over 10% of body mass over 6 months)
		☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Hepatomegaly is present.  If present, please include #mm below costal margin.
		☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Splenomegaly is present.  If present, please include #mm below costal margin
		☑	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-8010).
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Nursing Orders
☑	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Dose HOLD criteria for study drug:

o	Total bilirubin GREATER THAN 3.0 × ULN 
o	AST and/or ALT GREATER THAN 3.0 × ULN 
o	ALP GREATER THAN or EQUAL TO 2.5 × ULN 
o	ANC LESS THAN 1.0 × 109/L for subjects who enrolled with ANC GREATER THAN 1.5 × 109/L 
o	ANC LESS THAN 0.5 × 109/L for subjects who enrolled with ANC LESS THAN or EQUAL TO 1.5 × 109/L 
o	Platelet count is 50 to LESS THAN 75 × 109/L for subjects who enrolled with platelets GREATER THAN 100 × 109/L 
o	Platelet count is LESS THAN 50 × 109/L for subjects who enrolled with platelets LESS THAN or EQUAL TO 100 × 109/L 
o	Grade 4 ANC (LESS THAN 0.5 × 109/L) lasting 7 days 
o	GREATER THAN or EQUAL to Grade 3 ANC with an oral temperature of at least 38.5°C OR with GREATER THAN or EQUAL TO Grade 3 infection 
o	Platelet count is LESS THAN 50 × 109/L for subjects who enrolled with platelets GREATER THAN 100 × 109/L 
o	Platelet count is LESS THAN 25 × 109/L for subjects who enrolled with platelets LESS THAN or EQUAL TO 100 × 109/L 
o	Diarrhea/colitis (GREATER THAN or EQUAL TO Grade 2)
o	Pneumonitis (Grade GREATER THAN or EQUAL TO 1) 
o	Skin toxicity (eg, rash, pruritus, etc, unless otherwise specified) (Grade 2-3) 
o	Exfoliative dermatitis (GREATER THAN or EQUAL TO Grade 1) 
o	Intestinal perforation (any grade) 
o	Pneumocystis jiroveci pneumonia infection 
o	CMV infection 
o	Varicella zoster infection
			Nursing Orders
  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Chemistries:

AST and/or ALT GREATER than 3.0 × ULN 

Note: In subjects with bone metastasis-related elevations at baseline, contact sponsor to discuss clinical management and possible dose reductions. 	
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to Grade LESS than or EQUAL to 1 (unless approved otherwise by the medical monitor). 
Step 2: Restart INCB039110 at same dose. If assessed as related to INCB039110, restart at next lower dose. Monitor as clinically indicated. 

Hematology:

ANC LESS than or EQUAL to 1.0 × 109/L unless due to underlying disease 
o Platelet count is LESS than 60 × 109/L unless due to underlying disease 	
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to LESS than or EQUAL to Grade 1 or pretherapy baseline. 
Step 2: Restart INCB039110 at same dose; monitor as clinically indicated. 

Grade 4 ANC (LESS than 0.5 × 109/L) 
o GREATER than or EQUAL to Grade 3 ANC with an oral temperature of at least 38.5°C OR with GREATER than or EQUAL to Grade 3 infection. 
o Platelet count is LESS than 35 × 109/L 
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to LESS than or EQUAL to Grade 1. 
Step 2: Restart INCB039110 at same dose. If assessed as related to INCB039110, restart at next lower dose. Monitor as clinically indicated

Other toxicities: 

o Any Grade 1 or Grade 2 toxicity 
Continue study treatment and treat the toxicity; monitor as clinically indicated. 

o Any Grade 3 toxicity, if clinically significant and not manageable by supportive care 
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to LESS than or EQUAL to Grade 1. 
Step 2: Restart INCB039110 at same dose. If assessed as related to INCB039110, restart at next lower dose. Monitor as clinically indicated. 

o Any recurrent Grade 3 toxicity after 2 dose reductions 
Discontinue study drug administration and follow-up per Protocol. Exceptions require approval of sponsor. 

o Any other Grade 4 toxicity 
Discontinue study drug administration and follow-up per Protocol. Exceptions require approval of sponsor. 

Dose modifications of Ibrutinib:
o Grade 4 ANC (LESS than 0.5 × 109/L) for more than 7 days. 
o Grade 3 thrombocytopenia (LESS than 50 × 109/L) in the presence of clinically significant bleeding events. 
o Grade 4 thrombocytopenia (LESS than 25 × 109/L). 
o Grade 3 or 4 nausea, vomiting, or diarrhea if persistent, despite optimal antiemetic and/or antidiarrheal therapy. 
o Any other Grade 4 or unmanageable Grade 3 toxicity. 

For Grade 3 or 4 atrial fibrillation or persistent atrial fibrillation of any grade, the risks and benefits of ibrutinib treatment should be considered. 

Ibrutinib is metabolized in the liver. For subjects who develop mild liver impairment while on study (Child-Pugh Class A), the recommended dose reduction for ibrutinib is to a level of 280 mg daily (2 capsules). For subjects who develop moderate liver impairment while on study (Child-Pugh Class B), the recommended dose reduction is to a level of 140 mg daily (1 capsule). Subjects who develop severe hepatic impairment (Child-Pugh Class C) must withhold study drug

Toxicity Occurrence 	
Action to be Taken: 
First - Withhold study drug until recovery to Grade LESS than or EQUAL to 1 or baseline; may restart at original dose level. 
Second - Withhold study drug until recovery to Grade LESS than or EQUAL to 1 or baseline; may restart at 1 dose level lower (ie, 280 mg/day for 420 mg/day dose; 420 mg/day for 560 mg/day dose). 
Third - Withhold study drug until recovery to Grade LESS than or EQUAL to 1 or baseline; may restart at 1 dose level lower (ie, 140 mg/day for 420 mg/day dose; 280 mg/day for 560 mg/day dose). 
Fourth - Discontinue study drug.
					
Cycle 5	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	LDH	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		☑	PREALBUMIN LEVEL	Interval: --	Occurrences: --		☑	LIPID PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Nursing Orders
☑	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		☑	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Vital signs  (blood pressure, pulse, respiratory rate, body temperature, weight)
		☑	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical exam must be performed on this date
		☑	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Indicate in progress note a review of the subject's current B lymphoma signs and symptoms (drenching night sweats, fevers > 101°F [38.3°C], chills, unexplained weight loss of over 10% of body mass over 6 months)
		☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Hepatomegaly is present.  If present, please include #mm below costal margin.
		☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Splenomegaly is present.  If present, please include #mm below costal margin
		☑	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-8010).
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Nursing Orders
☑	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Dose HOLD criteria for study drug:

o	Total bilirubin GREATER THAN 3.0 × ULN 
o	AST and/or ALT GREATER THAN 3.0 × ULN 
o	ALP GREATER THAN or EQUAL TO 2.5 × ULN 
o	ANC LESS THAN 1.0 × 109/L for subjects who enrolled with ANC GREATER THAN 1.5 × 109/L 
o	ANC LESS THAN 0.5 × 109/L for subjects who enrolled with ANC LESS THAN or EQUAL TO 1.5 × 109/L 
o	Platelet count is 50 to LESS THAN 75 × 109/L for subjects who enrolled with platelets GREATER THAN 100 × 109/L 
o	Platelet count is LESS THAN 50 × 109/L for subjects who enrolled with platelets LESS THAN or EQUAL TO 100 × 109/L 
o	Grade 4 ANC (LESS THAN 0.5 × 109/L) lasting 7 days 
o	GREATER THAN or EQUAL to Grade 3 ANC with an oral temperature of at least 38.5°C OR with GREATER THAN or EQUAL TO Grade 3 infection 
o	Platelet count is LESS THAN 50 × 109/L for subjects who enrolled with platelets GREATER THAN 100 × 109/L 
o	Platelet count is LESS THAN 25 × 109/L for subjects who enrolled with platelets LESS THAN or EQUAL TO 100 × 109/L 
o	Diarrhea/colitis (GREATER THAN or EQUAL TO Grade 2)
o	Pneumonitis (Grade GREATER THAN or EQUAL TO 1) 
o	Skin toxicity (eg, rash, pruritus, etc, unless otherwise specified) (Grade 2-3) 
o	Exfoliative dermatitis (GREATER THAN or EQUAL TO Grade 1) 
o	Intestinal perforation (any grade) 
o	Pneumocystis jiroveci pneumonia infection 
o	CMV infection 
o	Varicella zoster infection
			Nursing Orders
  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Chemistries:

AST and/or ALT GREATER than 3.0 × ULN 

Note: In subjects with bone metastasis-related elevations at baseline, contact sponsor to discuss clinical management and possible dose reductions. 	
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to Grade LESS than or EQUAL to 1 (unless approved otherwise by the medical monitor). 
Step 2: Restart INCB039110 at same dose. If assessed as related to INCB039110, restart at next lower dose. Monitor as clinically indicated. 

Hematology:

ANC LESS than or EQUAL to 1.0 × 109/L unless due to underlying disease 
o Platelet count is LESS than 60 × 109/L unless due to underlying disease 	
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to LESS than or EQUAL to Grade 1 or pretherapy baseline. 
Step 2: Restart INCB039110 at same dose; monitor as clinically indicated. 

Grade 4 ANC (LESS than 0.5 × 109/L) 
o GREATER than or EQUAL to Grade 3 ANC with an oral temperature of at least 38.5°C OR with GREATER than or EQUAL to Grade 3 infection. 
o Platelet count is LESS than 35 × 109/L 
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to LESS than or EQUAL to Grade 1. 
Step 2: Restart INCB039110 at same dose. If assessed as related to INCB039110, restart at next lower dose. Monitor as clinically indicated

Other toxicities: 

o Any Grade 1 or Grade 2 toxicity 
Continue study treatment and treat the toxicity; monitor as clinically indicated. 

o Any Grade 3 toxicity, if clinically significant and not manageable by supportive care 
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to LESS than or EQUAL to Grade 1. 
Step 2: Restart INCB039110 at same dose. If assessed as related to INCB039110, restart at next lower dose. Monitor as clinically indicated. 

o Any recurrent Grade 3 toxicity after 2 dose reductions 
Discontinue study drug administration and follow-up per Protocol. Exceptions require approval of sponsor. 

o Any other Grade 4 toxicity 
Discontinue study drug administration and follow-up per Protocol. Exceptions require approval of sponsor. 

Dose modifications of Ibrutinib:
o Grade 4 ANC (LESS than 0.5 × 109/L) for more than 7 days. 
o Grade 3 thrombocytopenia (LESS than 50 × 109/L) in the presence of clinically significant bleeding events. 
o Grade 4 thrombocytopenia (LESS than 25 × 109/L). 
o Grade 3 or 4 nausea, vomiting, or diarrhea if persistent, despite optimal antiemetic and/or antidiarrheal therapy. 
o Any other Grade 4 or unmanageable Grade 3 toxicity. 

For Grade 3 or 4 atrial fibrillation or persistent atrial fibrillation of any grade, the risks and benefits of ibrutinib treatment should be considered. 

Ibrutinib is metabolized in the liver. For subjects who develop mild liver impairment while on study (Child-Pugh Class A), the recommended dose reduction for ibrutinib is to a level of 280 mg daily (2 capsules). For subjects who develop moderate liver impairment while on study (Child-Pugh Class B), the recommended dose reduction is to a level of 140 mg daily (1 capsule). Subjects who develop severe hepatic impairment (Child-Pugh Class C) must withhold study drug

Toxicity Occurrence 	
Action to be Taken: 
First - Withhold study drug until recovery to Grade LESS than or EQUAL to 1 or baseline; may restart at original dose level. 
Second - Withhold study drug until recovery to Grade LESS than or EQUAL to 1 or baseline; may restart at 1 dose level lower (ie, 280 mg/day for 420 mg/day dose; 420 mg/day for 560 mg/day dose). 
Third - Withhold study drug until recovery to Grade LESS than or EQUAL to 1 or baseline; may restart at 1 dose level lower (ie, 140 mg/day for 420 mg/day dose; 280 mg/day for 560 mg/day dose). 
Fourth - Discontinue study drug.
					
Cycle 6	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	LDH	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		☑	PREALBUMIN LEVEL	Interval: --	Occurrences: --		☑	LIPID PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Nursing Orders
☑	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		☑	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Vital signs  (blood pressure, pulse, respiratory rate, body temperature, weight)
		☑	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical exam must be performed on this date
		☑	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Indicate in progress note a review of the subject's current B lymphoma signs and symptoms (drenching night sweats, fevers > 101°F [38.3°C], chills, unexplained weight loss of over 10% of body mass over 6 months)
		☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Hepatomegaly is present.  If present, please include #mm below costal margin.
		☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Splenomegaly is present.  If present, please include #mm below costal margin
		☑	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-8010).
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Nursing Orders
☑	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	Dose HOLD criteria for study drug:

o	Total bilirubin GREATER THAN 3.0 × ULN 
o	AST and/or ALT GREATER THAN 3.0 × ULN 
o	ALP GREATER THAN or EQUAL TO 2.5 × ULN 
o	ANC LESS THAN 1.0 × 109/L for subjects who enrolled with ANC GREATER THAN 1.5 × 109/L 
o	ANC LESS THAN 0.5 × 109/L for subjects who enrolled with ANC LESS THAN or EQUAL TO 1.5 × 109/L 
o	Platelet count is 50 to LESS THAN 75 × 109/L for subjects who enrolled with platelets GREATER THAN 100 × 109/L 
o	Platelet count is LESS THAN 50 × 109/L for subjects who enrolled with platelets LESS THAN or EQUAL TO 100 × 109/L 
o	Grade 4 ANC (LESS THAN 0.5 × 109/L) lasting 7 days 
o	GREATER THAN or EQUAL to Grade 3 ANC with an oral temperature of at least 38.5°C OR with GREATER THAN or EQUAL TO Grade 3 infection 
o	Platelet count is LESS THAN 50 × 109/L for subjects who enrolled with platelets GREATER THAN 100 × 109/L 
o	Platelet count is LESS THAN 25 × 109/L for subjects who enrolled with platelets LESS THAN or EQUAL TO 100 × 109/L 
o	Diarrhea/colitis (GREATER THAN or EQUAL TO Grade 2)
o	Pneumonitis (Grade GREATER THAN or EQUAL TO 1) 
o	Skin toxicity (eg, rash, pruritus, etc, unless otherwise specified) (Grade 2-3) 
o	Exfoliative dermatitis (GREATER THAN or EQUAL TO Grade 1) 
o	Intestinal perforation (any grade) 
o	Pneumocystis jiroveci pneumonia infection 
o	CMV infection 
o	Varicella zoster infection
			Nursing Orders
  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	Chemistries:

AST and/or ALT GREATER than 3.0 × ULN 

Note: In subjects with bone metastasis-related elevations at baseline, contact sponsor to discuss clinical management and possible dose reductions. 	
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to Grade LESS than or EQUAL to 1 (unless approved otherwise by the medical monitor). 
Step 2: Restart INCB039110 at same dose. If assessed as related to INCB039110, restart at next lower dose. Monitor as clinically indicated. 

Hematology:

ANC LESS than or EQUAL to 1.0 × 109/L unless due to underlying disease 
o Platelet count is LESS than 60 × 109/L unless due to underlying disease 	
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to LESS than or EQUAL to Grade 1 or pretherapy baseline. 
Step 2: Restart INCB039110 at same dose; monitor as clinically indicated. 

Grade 4 ANC (LESS than 0.5 × 109/L) 
o GREATER than or EQUAL to Grade 3 ANC with an oral temperature of at least 38.5°C OR with GREATER than or EQUAL to Grade 3 infection. 
o Platelet count is LESS than 35 × 109/L 
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to LESS than or EQUAL to Grade 1. 
Step 2: Restart INCB039110 at same dose. If assessed as related to INCB039110, restart at next lower dose. Monitor as clinically indicated

Other toxicities: 

o Any Grade 1 or Grade 2 toxicity 
Continue study treatment and treat the toxicity; monitor as clinically indicated. 

o Any Grade 3 toxicity, if clinically significant and not manageable by supportive care 
Step 1: Interrupt INCB039110 up to 14 days until the toxicity has resolved to LESS than or EQUAL to Grade 1. 
Step 2: Restart INCB039110 at same dose. If assessed as related to INCB039110, restart at next lower dose. Monitor as clinically indicated. 

o Any recurrent Grade 3 toxicity after 2 dose reductions 
Discontinue study drug administration and follow-up per Protocol. Exceptions require approval of sponsor. 

o Any other Grade 4 toxicity 
Discontinue study drug administration and follow-up per Protocol. Exceptions require approval of sponsor. 

Dose modifications of Ibrutinib:
o Grade 4 ANC (LESS than 0.5 × 109/L) for more than 7 days. 
o Grade 3 thrombocytopenia (LESS than 50 × 109/L) in the presence of clinically significant bleeding events. 
o Grade 4 thrombocytopenia (LESS than 25 × 109/L). 
o Grade 3 or 4 nausea, vomiting, or diarrhea if persistent, despite optimal antiemetic and/or antidiarrheal therapy. 
o Any other Grade 4 or unmanageable Grade 3 toxicity. 

For Grade 3 or 4 atrial fibrillation or persistent atrial fibrillation of any grade, the risks and benefits of ibrutinib treatment should be considered. 

Ibrutinib is metabolized in the liver. For subjects who develop mild liver impairment while on study (Child-Pugh Class A), the recommended dose reduction for ibrutinib is to a level of 280 mg daily (2 capsules). For subjects who develop moderate liver impairment while on study (Child-Pugh Class B), the recommended dose reduction is to a level of 140 mg daily (1 capsule). Subjects who develop severe hepatic impairment (Child-Pugh Class C) must withhold study drug

Toxicity Occurrence 	
Action to be Taken: 
First - Withhold study drug until recovery to Grade LESS than or EQUAL to 1 or baseline; may restart at original dose level. 
Second - Withhold study drug until recovery to Grade LESS than or EQUAL to 1 or baseline; may restart at 1 dose level lower (ie, 280 mg/day for 420 mg/day dose; 420 mg/day for 560 mg/day dose). 
Third - Withhold study drug until recovery to Grade LESS than or EQUAL to 1 or baseline; may restart at 1 dose level lower (ie, 140 mg/day for 420 mg/day dose; 280 mg/day for 560 mg/day dose). 
Fourth - Discontinue study drug.
				Day 15-21	Perform every 1 day x1		Imaging
☑	CT SOFT TISSUE NECK W CONTRAST	Interval: --	Occurrences: --		☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --					
End of Treatment	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	LDH	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		☑	PREALBUMIN LEVEL	Interval: --	Occurrences: --		☑	LIPID PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Nursing Orders
☑	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		☑	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Vital signs  (blood pressure, pulse, respiratory rate, body temperature, weight)
		☑	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical exam must be performed on this date
		☑	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Indicate in progress note a review of the subject's current B lymphoma signs and symptoms (drenching night sweats, fevers > 101°F [38.3°C], chills, unexplained weight loss of over 10% of body mass over 6 months)
		☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Hepatomegaly is present.  If present, please include #mm below costal margin.
		☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Splenomegaly is present.  If present, please include #mm below costal margin
		☑	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-8010).
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 15-21	Perform every 1 day x1		Imaging
☑	CT SOFT TISSUE NECK W CONTRAST	Interval: --	Occurrences: --		☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --					
Follow Up	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		☑	URIC ACID LEVEL	Interval: --	Occurrences: --		☑	LDH	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		☑	PREALBUMIN LEVEL	Interval: --	Occurrences: --		☑	LIPID PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Nursing Orders
☑	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		☑	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Vital signs  (blood pressure, pulse, respiratory rate, body temperature, weight)
		☑	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical exam must be performed on this date
		☑	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Indicate in progress note a review of the subject's current B lymphoma signs and symptoms (drenching night sweats, fevers > 101°F [38.3°C], chills, unexplained weight loss of over 10% of body mass over 6 months)
		☑	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Hepatomegaly is present.  If present, please include #mm below costal margin.
		☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	If lymphoma, indicate in Progress note if Splenomegaly is present.  If present, please include #mm below costal margin
		☑	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-8010).
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Long Term Follow-up	Repeat 1 time	Cycle length: 91 days	Day 84	Perform every 1 day x1