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RESEARCH PRO00015047 INCB-57643 IYER	

Types:      Research Oncology Treatment
Synonyms:  INCB, PRO15047, INCB57643

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.
		☑	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: --		☑	PET CT SKULL BASE TO MID THIGH	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, respiratory 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)
		☑	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical exam must be performed on this date
		☑	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	If lymphoma, 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
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Nursing Orders
☑	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate for immunophenotyping
		☑	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Bone marrow biopsy - with full pathology evaluation (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: 21 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: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	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, respiratory rate, temperature)
		☑	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:	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:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-9984); on C1/D1 and C1/D15, ECGs will be in triplicate at pre-dose, and 2 and 4 hours post-dose.
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	General Toxicities:
Any grade 3 toxicity, if clinically significant and not manageable by supportive care: 

1. Interrupt study drug up to 2 weeks (14 days), until toxicity resolves to LESS THAN or EQUAL TO Grade 1. 
2. Restart study drug at next lower dose (or 25% reduction, whichever is the smaller increment, rounded down to the nearest pill strength); monitor as clinically indicated. 

Any grade 4 toxicity - discontinue study treatment.

Chemistries:

AST and/or ALT is GREATER THAN 5.0 and LESS THAN 20.0 × ULN  -  Interrupt study drug up to 2 weeks (14 days) until the toxicity has resolved to LESS THAN or EQUAL TO Grade 1. Restart study drug at next lower dose.

AST and/or ALT is GREATER THAN OR EQUAL TO 20.0 × ULN - discontinue study treatment.

ALT GREATER THAN 3.0 × ULN, ALP LESS THAN 2 × ULN, and bilirubin GREATER THAN or EQUAL TO 2.0 × ULN (Hy's Law), and no other immediately apparent possible cause of aminotransferase elevation and hyperbilirubinemia, including, but not limited to, viral hepatitis, pre-existing chronic or acute liver disease, or the administration of other drug(s) known to be hepatotoxic - discontinue treatment.

Hematology:

For TGB: Leukemia (any), AML, or myelodysplastic syndrome (MDS), thrombocytopenia, neutropenia, and anemia should be managed as per institutional standard.

For all others:

Platelets:  LESS THAN 50:  Hold study treatment until resolved to GREATER THAN or EQUAL TO 75; monitor CBC about every 3 days.
LESS THAN 25:  discontinue study treatment if accompanied with clinical symptoms.

ANC: LESS THAN 1.0:  Hold until resolved to GREATER THAN or EQUAL TO 1.5; monitor CBC approximately every 3 days. 
LESS THAN 0.5:  discontinue study treatment if accompanied with clinical symptoms. 

Hemoglobin LESS THAN 8.0:  Hold until resolved to GREATER THAN or EQUAL TO 10.0; monitor CBC approximately every 3 days.
LESS THAN 6.5:  discontinue study treatment if accompanied with clinical symptoms.
			Biologicals
  	PLACEHOLDER	Dose: --	Route: --		Start: S						Day 2	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: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	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, respiratory rate, temperature)
		☑	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:	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:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-9984); on C1/D1 and C1/D15, ECGs will be in triplicate at pre-dose, and 2 and 4 hours post-dose.
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Days 3,4,5	Perform every 1 day x3		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, respiratory rate, temperature)
		☑	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:	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:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-9984); on C1/D1 and C1/D15, ECGs will be in triplicate at pre-dose, and 2 and 4 hours post-dose.
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				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: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	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: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	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, respiratory rate, temperature)
		☑	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:	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:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-9984); on C1/D1 and C1/D15, ECGs will be in triplicate at pre-dose, and 2 and 4 hours post-dose.
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Cycle 2	Repeat 1 time	Cycle length: 21 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: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		☑	LIPID PANEL	Interval: --	Occurrences: --		☑	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, heart rate, respiratory rate, temperature)
		☑	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:	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:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-9984).
			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	Interval: --	Occurrences: --	Comments:	General Toxicities:
Any grade 3 toxicity, if clinically significant and not manageable by supportive care: 

1. Interrupt study drug up to 2 weeks (14 days), until toxicity resolves to LESS THAN or EQUAL TO Grade 1. 
2. Restart study drug at next lower dose (or 25% reduction, whichever is the smaller increment, rounded down to the nearest pill strength); monitor as clinically indicated. 

Any grade 4 toxicity - discontinue study treatment.

Chemistries:

AST and/or ALT is GREATER THAN 5.0 and LESS THAN 20.0 × ULN  -  Interrupt study drug up to 2 weeks (14 days) until the toxicity has resolved to LESS THAN or EQUAL TO Grade 1. Restart study drug at next lower dose.

AST and/or ALT is GREATER THAN OR EQUAL TO 20.0 × ULN - discontinue study treatment.

ALT GREATER THAN 3.0 × ULN, ALP LESS THAN 2 × ULN, and bilirubin GREATER THAN or EQUAL TO 2.0 × ULN (Hy's Law), and no other immediately apparent possible cause of aminotransferase elevation and hyperbilirubinemia, including, but not limited to, viral hepatitis, pre-existing chronic or acute liver disease, or the administration of other drug(s) known to be hepatotoxic - discontinue treatment.

Hematology:

For TGB: Leukemia (any), AML, or myelodysplastic syndrome (MDS), thrombocytopenia, neutropenia, and anemia should be managed as per institutional standard.

For all others:

Platelets:  LESS THAN 50:  Hold study treatment until resolved to GREATER THAN or EQUAL TO 75; monitor CBC about every 3 days.
LESS THAN 25:  discontinue study treatment if accompanied with clinical symptoms.

ANC: LESS THAN 1.0:  Hold until resolved to GREATER THAN or EQUAL TO 1.5; monitor CBC approximately every 3 days. 
LESS THAN 0.5:  discontinue study treatment if accompanied with clinical symptoms. 

Hemoglobin LESS THAN 8.0:  Hold until resolved to GREATER THAN or EQUAL TO 10.0; monitor CBC approximately every 3 days.
LESS THAN 6.5:  discontinue study treatment if accompanied with clinical symptoms.
			Biologicals
  	PLACEHOLDER	Dose: --	Route: --		Start: S						Days 3,4,5	Perform every 1 day x3		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, respiratory rate, temperature)
		☑	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:	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:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-9984); on C1/D1 and C1/D15, ECGs will be in triplicate at pre-dose, and 2 and 4 hours post-dose.
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 11	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: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	Interval: --	Occurrences: --					
Cycle 3	Repeat 1 time	Cycle length: 21 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: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	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, respiratory rate, temperature)
		☑	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:	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:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-9984).
			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	Interval: --	Occurrences: --	Comments:	General Toxicities:
Any grade 3 toxicity, if clinically significant and not manageable by supportive care: 

1. Interrupt study drug up to 2 weeks (14 days), until toxicity resolves to LESS THAN or EQUAL TO Grade 1. 
2. Restart study drug at next lower dose (or 25% reduction, whichever is the smaller increment, rounded down to the nearest pill strength); monitor as clinically indicated. 

Any grade 4 toxicity - discontinue study treatment.

Chemistries:

AST and/or ALT is GREATER THAN 5.0 and LESS THAN 20.0 × ULN  -  Interrupt study drug up to 2 weeks (14 days) until the toxicity has resolved to LESS THAN or EQUAL TO Grade 1. Restart study drug at next lower dose.

AST and/or ALT is GREATER THAN OR EQUAL TO 20.0 × ULN - discontinue study treatment.

ALT GREATER THAN 3.0 × ULN, ALP LESS THAN 2 × ULN, and bilirubin GREATER THAN or EQUAL TO 2.0 × ULN (Hy's Law), and no other immediately apparent possible cause of aminotransferase elevation and hyperbilirubinemia, including, but not limited to, viral hepatitis, pre-existing chronic or acute liver disease, or the administration of other drug(s) known to be hepatotoxic - discontinue treatment.

Hematology:

For TGB: Leukemia (any), AML, or myelodysplastic syndrome (MDS), thrombocytopenia, neutropenia, and anemia should be managed as per institutional standard.

For all others:

Platelets:  LESS THAN 50:  Hold study treatment until resolved to GREATER THAN or EQUAL TO 75; monitor CBC about every 3 days.
LESS THAN 25:  discontinue study treatment if accompanied with clinical symptoms.

ANC: LESS THAN 1.0:  Hold until resolved to GREATER THAN or EQUAL TO 1.5; monitor CBC approximately every 3 days. 
LESS THAN 0.5:  discontinue study treatment if accompanied with clinical symptoms. 

Hemoglobin LESS THAN 8.0:  Hold until resolved to GREATER THAN or EQUAL TO 10.0; monitor CBC approximately every 3 days.
LESS THAN 6.5:  discontinue study treatment if accompanied with clinical symptoms.
			Biologicals
  	PLACEHOLDER	Dose: --	Route: --		Start: S						Days 3,4,5	Perform every 1 day x3		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, respiratory rate, temperature)
		☑	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:	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:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-9984); on C1/D1 and C1/D15, ECGs will be in triplicate at pre-dose, and 2 and 4 hours post-dose.
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 11	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: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	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: --		☑	PET CT SKULL BASE TO MID THIGH	Interval: --	Occurrences: --					
Cycle 4	Repeat 1 time	Cycle length: 21 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: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		☑	LIPID PANEL	Interval: --	Occurrences: --		☑	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, heart rate, respiratory rate, temperature)
		☑	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:	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:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-9984).
			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	Interval: --	Occurrences: --	Comments:	General Toxicities:
Any grade 3 toxicity, if clinically significant and not manageable by supportive care: 

1. Interrupt study drug up to 2 weeks (14 days), until toxicity resolves to LESS THAN or EQUAL TO Grade 1. 
2. Restart study drug at next lower dose (or 25% reduction, whichever is the smaller increment, rounded down to the nearest pill strength); monitor as clinically indicated. 

Any grade 4 toxicity - discontinue study treatment.

Chemistries:

AST and/or ALT is GREATER THAN 5.0 and LESS THAN 20.0 × ULN  -  Interrupt study drug up to 2 weeks (14 days) until the toxicity has resolved to LESS THAN or EQUAL TO Grade 1. Restart study drug at next lower dose.

AST and/or ALT is GREATER THAN OR EQUAL TO 20.0 × ULN - discontinue study treatment.

ALT GREATER THAN 3.0 × ULN, ALP LESS THAN 2 × ULN, and bilirubin GREATER THAN or EQUAL TO 2.0 × ULN (Hy's Law), and no other immediately apparent possible cause of aminotransferase elevation and hyperbilirubinemia, including, but not limited to, viral hepatitis, pre-existing chronic or acute liver disease, or the administration of other drug(s) known to be hepatotoxic - discontinue treatment.

Hematology:

For TGB: Leukemia (any), AML, or myelodysplastic syndrome (MDS), thrombocytopenia, neutropenia, and anemia should be managed as per institutional standard.

For all others:

Platelets:  LESS THAN 50:  Hold study treatment until resolved to GREATER THAN or EQUAL TO 75; monitor CBC about every 3 days.
LESS THAN 25:  discontinue study treatment if accompanied with clinical symptoms.

ANC: LESS THAN 1.0:  Hold until resolved to GREATER THAN or EQUAL TO 1.5; monitor CBC approximately every 3 days. 
LESS THAN 0.5:  discontinue study treatment if accompanied with clinical symptoms. 

Hemoglobin LESS THAN 8.0:  Hold until resolved to GREATER THAN or EQUAL TO 10.0; monitor CBC approximately every 3 days.
LESS THAN 6.5:  discontinue study treatment if accompanied with clinical symptoms.
			Biologicals
  	PLACEHOLDER	Dose: --	Route: --		Start: S						Day 11	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: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	Interval: --	Occurrences: --					
Cycle 5	Repeat 1 time	Cycle length: 21 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: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	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, respiratory rate, temperature)
		☑	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:	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:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-9984).
			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	Interval: --	Occurrences: --	Comments:	General Toxicities:
Any grade 3 toxicity, if clinically significant and not manageable by supportive care: 

1. Interrupt study drug up to 2 weeks (14 days), until toxicity resolves to LESS THAN or EQUAL TO Grade 1. 
2. Restart study drug at next lower dose (or 25% reduction, whichever is the smaller increment, rounded down to the nearest pill strength); monitor as clinically indicated. 

Any grade 4 toxicity - discontinue study treatment.

Chemistries:

AST and/or ALT is GREATER THAN 5.0 and LESS THAN 20.0 × ULN  -  Interrupt study drug up to 2 weeks (14 days) until the toxicity has resolved to LESS THAN or EQUAL TO Grade 1. Restart study drug at next lower dose.

AST and/or ALT is GREATER THAN OR EQUAL TO 20.0 × ULN - discontinue study treatment.

ALT GREATER THAN 3.0 × ULN, ALP LESS THAN 2 × ULN, and bilirubin GREATER THAN or EQUAL TO 2.0 × ULN (Hy's Law), and no other immediately apparent possible cause of aminotransferase elevation and hyperbilirubinemia, including, but not limited to, viral hepatitis, pre-existing chronic or acute liver disease, or the administration of other drug(s) known to be hepatotoxic - discontinue treatment.

Hematology:

For TGB: Leukemia (any), AML, or myelodysplastic syndrome (MDS), thrombocytopenia, neutropenia, and anemia should be managed as per institutional standard.

For all others:

Platelets:  LESS THAN 50:  Hold study treatment until resolved to GREATER THAN or EQUAL TO 75; monitor CBC about every 3 days.
LESS THAN 25:  discontinue study treatment if accompanied with clinical symptoms.

ANC: LESS THAN 1.0:  Hold until resolved to GREATER THAN or EQUAL TO 1.5; monitor CBC approximately every 3 days. 
LESS THAN 0.5:  discontinue study treatment if accompanied with clinical symptoms. 

Hemoglobin LESS THAN 8.0:  Hold until resolved to GREATER THAN or EQUAL TO 10.0; monitor CBC approximately every 3 days.
LESS THAN 6.5:  discontinue study treatment if accompanied with clinical symptoms.
			Biologicals
  	PLACEHOLDER	Dose: --	Route: --		Start: S						Day 11	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: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	Interval: --	Occurrences: --					
Cycle 6	Repeat 1 time	Cycle length: 21 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: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	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, respiratory rate, temperature)
		☑	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:	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:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-9984).
			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	Interval: --	Occurrences: --	Comments:	General Toxicities:
Any grade 3 toxicity, if clinically significant and not manageable by supportive care: 

1. Interrupt study drug up to 2 weeks (14 days), until toxicity resolves to LESS THAN or EQUAL TO Grade 1. 
2. Restart study drug at next lower dose (or 25% reduction, whichever is the smaller increment, rounded down to the nearest pill strength); monitor as clinically indicated. 

Any grade 4 toxicity - discontinue study treatment.

Chemistries:

AST and/or ALT is GREATER THAN 5.0 and LESS THAN 20.0 × ULN  -  Interrupt study drug up to 2 weeks (14 days) until the toxicity has resolved to LESS THAN or EQUAL TO Grade 1. Restart study drug at next lower dose.

AST and/or ALT is GREATER THAN OR EQUAL TO 20.0 × ULN - discontinue study treatment.

ALT GREATER THAN 3.0 × ULN, ALP LESS THAN 2 × ULN, and bilirubin GREATER THAN or EQUAL TO 2.0 × ULN (Hy's Law), and no other immediately apparent possible cause of aminotransferase elevation and hyperbilirubinemia, including, but not limited to, viral hepatitis, pre-existing chronic or acute liver disease, or the administration of other drug(s) known to be hepatotoxic - discontinue treatment.

Hematology:

For TGB: Leukemia (any), AML, or myelodysplastic syndrome (MDS), thrombocytopenia, neutropenia, and anemia should be managed as per institutional standard.

For all others:

Platelets:  LESS THAN 50:  Hold study treatment until resolved to GREATER THAN or EQUAL TO 75; monitor CBC about every 3 days.
LESS THAN 25:  discontinue study treatment if accompanied with clinical symptoms.

ANC: LESS THAN 1.0:  Hold until resolved to GREATER THAN or EQUAL TO 1.5; monitor CBC approximately every 3 days. 
LESS THAN 0.5:  discontinue study treatment if accompanied with clinical symptoms. 

Hemoglobin LESS THAN 8.0:  Hold until resolved to GREATER THAN or EQUAL TO 10.0; monitor CBC approximately every 3 days.
LESS THAN 6.5:  discontinue study treatment if accompanied with clinical symptoms.
			Biologicals
  	PLACEHOLDER	Dose: --	Route: --		Start: S						Day 11	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: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	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: --		☑	PET CT SKULL BASE TO MID THIGH	Interval: --	Occurrences: --					
Cycle 7	Repeat 1 time	Cycle length: 21 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: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		☑	LIPID PANEL	Interval: --	Occurrences: --		☑	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, heart rate, respiratory rate, temperature)
		☑	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:	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:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-9984).
			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	Interval: --	Occurrences: --	Comments:	General Toxicities:
Any grade 3 toxicity, if clinically significant and not manageable by supportive care: 

1. Interrupt study drug up to 2 weeks (14 days), until toxicity resolves to LESS THAN or EQUAL TO Grade 1. 
2. Restart study drug at next lower dose (or 25% reduction, whichever is the smaller increment, rounded down to the nearest pill strength); monitor as clinically indicated. 

Any grade 4 toxicity - discontinue study treatment.

Chemistries:

AST and/or ALT is GREATER THAN 5.0 and LESS THAN 20.0 × ULN  -  Interrupt study drug up to 2 weeks (14 days) until the toxicity has resolved to LESS THAN or EQUAL TO Grade 1. Restart study drug at next lower dose.

AST and/or ALT is GREATER THAN OR EQUAL TO 20.0 × ULN - discontinue study treatment.

ALT GREATER THAN 3.0 × ULN, ALP LESS THAN 2 × ULN, and bilirubin GREATER THAN or EQUAL TO 2.0 × ULN (Hy's Law), and no other immediately apparent possible cause of aminotransferase elevation and hyperbilirubinemia, including, but not limited to, viral hepatitis, pre-existing chronic or acute liver disease, or the administration of other drug(s) known to be hepatotoxic - discontinue treatment.

Hematology:

For TGB: Leukemia (any), AML, or myelodysplastic syndrome (MDS), thrombocytopenia, neutropenia, and anemia should be managed as per institutional standard.

For all others:

Platelets:  LESS THAN 50:  Hold study treatment until resolved to GREATER THAN or EQUAL TO 75; monitor CBC about every 3 days.
LESS THAN 25:  discontinue study treatment if accompanied with clinical symptoms.

ANC: LESS THAN 1.0:  Hold until resolved to GREATER THAN or EQUAL TO 1.5; monitor CBC approximately every 3 days. 
LESS THAN 0.5:  discontinue study treatment if accompanied with clinical symptoms. 

Hemoglobin LESS THAN 8.0:  Hold until resolved to GREATER THAN or EQUAL TO 10.0; monitor CBC approximately every 3 days.
LESS THAN 6.5:  discontinue study treatment if accompanied with clinical symptoms.
			Biologicals
  	PLACEHOLDER	Dose: --	Route: --		Start: S						Day 11	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: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	Interval: --	Occurrences: --					
End of Treatment	Repeat 1 time	Cycle length: 21 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: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		☑	LIPID PANEL	Interval: --	Occurrences: --		☑	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, heart rate, respiratory rate, temperature)
		☑	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:	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:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-9984); on C1/D1 and C1/D15, ECGs will be in triplicate at pre-dose, and 2 and 4 hours post-dose.
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Safety Follow Up	Repeat 1 time	Cycle length: 84 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: --		☑	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	If total bilirubin is abnormal.
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MANUAL DIFFERENTIAL	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If applicable
		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		☑	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, heart rate, respiratory rate, temperature)
		☑	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:	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:	12-lead ECG - Study staff to perform (Contact CCAT at 713-441-9984); on C1/D1 and C1/D15, ECGs will be in triplicate at pre-dose, and 2 and 4 hours post-dose.
			Pharmacokinetic Instructions
☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --