Protocol Index	

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OP RESEARCH PRO00035985 EA9181 NCT04530565 STEP 0 PRE-REGISTRATION SHAH	

Types:      Research Oncology Treatment
Synonyms:  

Cycle 1	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA9181-Shah
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Physical Examination
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	AEs
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Appointment Requests
  	IR LUMBAR PUNCTURE	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 1 week prior to registration
			Procedures
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	Bone Marrow Aspirate, and Biopsy - 
o To be completed LESS than or EQUAL to 1 week prior to registration. 
o Can either be performed on bone marrow or peripheral blood specimen (according to investigator discretion).
Submit two (2) original karyotypes per clone, FISH results, institution's cytogenetic laboratory report, and the Leukemia Cytogenetic Form (#365R) via Medidata Rave. Cytogenetics are only required at time of initial diagnosis and are optional at all later time points. Direct questions to Sarina Sherpa at Tel: (212) 639-8835
			Labs
  	FLOW CYTOMETRY EVALUATION	Interval: --	Occurrences: --	Comments:	o To be completed LESS than or EQUAL to 1 week prior to registration. 
o Can either be performed on bone marrow or peripheral blood specimen (according to investigator discretion).
Submit two (2) original karyotypes per clone, FISH results, institution's cytogenetic laboratory report, and the Leukemia Cytogenetic Form (#365R) via Medidata Rave. Cytogenetics are only required at time of initial diagnosis and are optional at all later time points. Direct questions to Sarina Sherpa at Tel: (212) 639-8835
		  	CYTOLOGY (NON-GYNECOLOGICAL) REQUEST	Interval: --	Occurrences: --	Comments:	Cytogenetics - 
o To be completed LESS than or EQUAL to 1 week prior to registration. 
o Can either be performed on bone marrow or peripheral blood specimen (according to investigator discretion).
Submit two (2) original karyotypes per clone, FISH results, institution's cytogenetic laboratory report, and the Leukemia Cytogenetic Form (#365R) via Medidata Rave. Cytogenetics are only required at time of initial diagnosis and are optional at all later time points. Direct questions to Sarina Sherpa at Tel: (212) 639-8835
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Bone marrow specimen must be submitted to ECOG-ACRIN Leukemia Bank at MD Anderson Cancer Center for the central establishment of BCR/ABL status to confirm patient's eligibility for registration to Step 1. If a diagnosis of BCR-ABL positive ALL has been established locally, the patient may be registered to Step 1 without waiting for central confirmation. Peripheral Blood is only acceptable if there is circulating blasts
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 1 week prior to registration.
Bone marrow aspirates are required to be submitted for centralized Multiparameter Flow and BCR-ABL status testing via FISH following preregistration to determine patient eligibility or evaluability as outlined in Section 10. Submit to the ECOG-ACRIN Leukemia Laboratory at MD Anderson Cancer Center. The centralized Flow and BCR-ABL status testing is mandatory for participation in this study. Results will be forwarded to the submitting institution within 48 hours of receipt of the specimen. In cases where the bone marrow aspiration may be inadequate, peripheral blood (10mL EDTA tube) may be submitted, given that adequate circulating blasts (>10%) are present.
The laboratory will accept any amount as long as it represents the first pull). Ideally, 2-3mL of aspirate from separate aspiration site should be submitted
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	To be completed LESS than or EQUAL to 1 week prior to registration. 
Bone marrow aspirates are required to be submitted for centralized Multiparameter Flow and BCR-ABL status testing via FISH following preregistration to determine patient eligibility or evaluability as outlined in Section 10. Submit to the ECOG-ACRIN Leukemia Laboratory at MD Anderson Cancer Center. The centralized Flow and BCR-ABL status testing is mandatory for participation in this study. Results will be forwarded to the submitting institution within 48 hours of receipt of the specimen. In cases where the bone marrow aspiration may be inadequate, peripheral blood (10mL EDTA tube) may be submitted, given that adequate circulating blasts (>10%) are present.
The EA Leukemia Laboratory will forward residual nucleic acids from the baseline diagnostic specimen to Fred Hutchinson Cancer Research Center for retrospective confirmation of the BCR-ABL status.
			Labs
  	ECG 12-LEAD	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	All required pre-study chemistry should be done LESS than or EQUAL 1 week before registration to each step - unless specifically required on Day 1 as per protocol. If abnormal, they must be repeated within 48 hours prior to registration. Serum creatinine and total/direct bilirubin must be completed LESS than or EQUAL to 48 hours before registration.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	CBCs (with differential and platelet count) which includes WBC, ANC, Platelets, Hgb, and Hct required for protocol therapy must be done LESS than  24 hours prior to registration
		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --	Comments:	Required for protocol therapy must be done LESS than 24 hours prior to registration
		  	HLA SPECIMEN	Interval: --	Occurrences: --	Comments:	HLA typing - For patients who are considered to be SCT candidates. High resolution class I and class II typing should be performed
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	o To be completed LESS than 1 week prior to registration. 
o LFTs must be done LESS than or EQUAL to  48 hours before registration to Step 1. If abnormal, they must be repeated within 48 hours prior to registration. Serum creatinine and total/direct bilirubin must be completed LESS than ot EQUAL to 48 hours before registration.
		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	LFTs must be done LESS than or EQUAL to  48 hours before registration to Step 1. If abnormal, they must be repeated within 48 hours prior to registration. Serum creatinine and total/direct bilirubin must be completed LESS than ot EQUAL to 48 hours before registration.
		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	Prior to registration
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	Prior to registration
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	Prior to registration
		  	D-DIMER	Interval: --	Occurrences: --	Comments:	Prior to registration
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	o All patients of childbearing potential must have a negative [blood test or urine test] within 14 days prior to Step 1 registration to rule out pregnancy. 
o Order urine pregnancy test if appropriate.
		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	Prior to registration
		  	HEPATITIS B CORE ANTIBODY IGM	Interval: --	Occurrences: --	Comments:	Prior to registration
		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --	Comments:	Prior to registration