Phase II Decitabine (DAC) Versus Azacitidine (AZA) in Myelodysplastic Syndrome (MDS)
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring Leukemia, Myelodysplastic syndrome, MDS, Low or intermediate-1 risk, Transfusion-dependent, Transfusion-independent, Best supportive care, BSC, Azacitidine, 5-Azacytidine, 5-AZA, Vidaza, 5-AZC, AZA-CR, Ladakamycin, NSC-102816, Azacytidine, Decitabine, Dacogen
Eligibility Criteria
Inclusion Criteria:
- Sign an IRB-approved informed consent document.
- Age >/= 18 years.
- IPSS low- or intermediate-1-risk MDS, including CMML-1
- ECOG performance status of </= 3 at study entry.
- Organ function defined as: Serum creatinine </= 2 mg/dL; Total bilirubin </= 2 x ULN; ALT (SGPT) </= 2 x ULN; AST (SGOT) </= 2 x ULN
- Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and will also need to use contraceptives. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
Exclusion Criteria:
- Breast feeding females
- Prior therapy with decitabine or azacitidine
Sites / Locations
- Moffitt Cancer Center
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Dana-Farber Cancer Institute
- NYP/Weill Cornell Medical Center
- Cleveland Clinic Foundation
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Other
Azacitidine (AZA) - Days 1 - 3
Azacitidine (AZA) - Days 1 - 5
Decitabine (DAC)
Best Supportive Care (BSC)
Azacitidine (AZA) Azacitidine 75 mg/m2 by vein or subcutaneously daily for 3 days (days 1-3) approximately every 28 days.
Azacitidine (AZA) 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.
Decitabine 20 mg/m2 by vein for 3 days (days 1-3) approximately every 28 days.
Participants receive standard of care as chosen by study doctor. Best supportive care for transfusion-independent participants only.