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OP RESEARCH PRO00037014 / SHAH BMS CA055-026 AZACITIDINE RANDOMIZED SCREENING	

Types:      Research Oncology Treatment
Synonyms:  MYELODYSPLASTIC SYNDROME, MDS, ORAL-AZA, ONUREG, SUPPORTIVE CARE, BSC, PLACEBO, IPSS-R

Screening (	Repeat 1 time	Cycle length: 28 days	Day -28	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Informed Consent - An eligible participant is considered enrolled only when a protocol specific informed consent is signed. Must be obtained prior to performing any screening procedures.
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Inclusion / Exclusion Criteria
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	MDS Diagnosis, WHO Classification, and IPSS-R Score - MDS diagnosis, WHO classification (Appendix 7), and IPSS-R risk classification will be prospectively determined by independent central pathology and cytogenetics review, and applicable central laboratory results.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	IRT Assignment - Sites will use the IRT for participant number assignment.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Demographics
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Medical History - All medical history relevant to disease under study.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Physical Examination
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include temperature, blood pressure, pulse, and respiration rate.
		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Prior / Concomitant Medications
		  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Prior / Concomitant Procedures
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Monitor for Adverse Events (AEs) and Serious Adverse Events (SAEs) - Continuous starting after informed consent signature, until 28 days after the last dose of Investigational Product or End of Treatment Visit, whichever occurs later.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Electrocardiogram will be performed locally at screening. The investigator will review and assess the results.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	pRBC and Platelet Transfusions - Transfusion history will be collected for a minimum of 112 days prior to randomization.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	A sample for hematology, without G-CSF/GM-CSF administration within 3 days or without Pegylated G-CSF administration within 14 days, must be collected within 7 days of first dose to determine baseline ANC, baseline platelet counts, baseline hemoglobin, etc. Any or all laboratory assessments may be repeated more frequently if clinically indicated. All samples will be analyzed by the central laboratory.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Serum chemistry parameters samples will be analyzed by the central laboratory. Any or all laboratory assessments may be repeated more frequently if clinically indicated.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: --	Occurrences: --	Comments:	Urine sample will be analyzed by local laboratory.  Urinalysis panel includes, at minimum, glucose, protein, blood, leukocyte esterase, and nitrites (dipstick testing). A microscopic examination (including casts, RBCs, and WBCs) will be performed in the event of a positive result for, at minimum, blood, leukocyte esterase, or nitrites.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	CORD BLOOD EVALUATION	Interval: --	Occurrences: --	Comments:	Or Indirect Coombs; Performed at the local laboratory and documented in the eCRF.
		  	ANTIBODY SCREEN	Interval: --	Occurrences: --	Comments:	Or Direct Coombs; Performed at the local laboratory and documented in the eCRF.
		  	RETICULOCYTE COUNT	Interval: --	Occurrences: --	Comments:	Performed at the local laboratory and documented in the eCRF.
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For Women of Childbearing Potential (WOCBP) only.  For WOCBP, a medically supervised serum pregnancy test is to be obtained and verified negative at screening. Note that the screening pregnancy test can be used as the test prior to starting study therapy in the treatment phase if it is performed within the 72-hour time frame. The participant may not receive Investigatonal Product until the investigator has verified that the result of the pregnancy test is negative. Serum pregnancy test during screening should be submitted to the local laboratory.
		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Females LESS than 55 years only.  Females under the age of 55 years must have a serum follicle-stimulating hormone (FSH) level GREATER than 40 mIU/mL to confirm menopause. This will be collected locally.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirate and biopsy samples together with peripheral blood samples must be collected at screening. Blood samples at screening should be collected on the same day as the bone marrow aspirate/biopsy procedure. Instructions for submission of bone marrow slides, sample collection, processing, storage, and shipment procedures are provided in the study's Central Laboratory Manual.  Bone marrow biopsy aspirate samples must be submitted to the central laboratory for analysis.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples will be appropriately processed for DNA/RNA isolation, and single cell enrichment (i.e., scRNAseq, cell processing for immune analyses). Samples will be bio-banked for retrospective analyses.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --