Phase 2 Completed N=185 Randomized Treatment

Phase II Decitabine (DAC) Versus Azacitidine (AZA) in Myelodysplastic Syndrome (MDS)

leukemia

Source: ClinicalTrials.gov NCT02269280 ↗

Enrolled (actual)

185

Serious AEs

3.8%

Results posted

Aug 2025

Primary outcomePrimary: Event Free Survival (EFS) — 14.1; 18.0; 9.8; 13.3 Months

Summary

The goal of this clinical research study is to compare how 2 different drugs, decitabine and azacitidine, when given on a shorter than standard dosing schedule, may help to control MDS. The safety of each study drug given on these schedules will also be studied. This is an investigational study. Decitabine and azacitidine are both FDA approved and commercially available for use in patients with MDS. Giving these drugs on a different schedule than is standard is considered investigational. The study doctor can tell you how the study drugs are designed to work.

Outcome Measures

Outcome	Result	p-value
PRIMARY Event Free Survival (EFS)	14.1; 18.0; 9.8; 13.3	—
SECONDARY Number of Participants With Overall Improvement	22; 27; 29; 0	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02269280). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.