NCT02269280CompletedPhase 2
Phase II Decitabine (DAC) Versus Azacitidine (AZA) in Myelodysplastic Syndrome (MDS)
Phase II Randomized Study of Lower Doses of Decitabine (DAC; 20 mg/m2 IV Daily for 3 Days Every Month) Versus Azacitidine (AZA; 75 mg/m2 SC/IV Daily for 3 Days Every Month) Versus Azacitidine (AZA; 75 mg/m2 SC/IV Daily for 5 Days Every Month) in MDS Patients With Low and Intermediate-1 Risk Disease Transfusion-Dependent Versus Best Supportive Care (BSC) in MDS Patients With Low and Intermediate-1 Risk Disease Transfusion-Independent
Source: ClinicalTrials.gov · Last updated 7 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 185 (actual)
- First submitted
- 13 Oct 2014
- Start date
- 13 Oct 2014
- Primary completion date
- 25 Jul 2024
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Myelodysplastic syndromes
- NCT number
- NCT02269280
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 185
- From 13 Oct 2014 to the primary completion date, 25 Jul 2024
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior therapy with decitabine or azacitidine
Other
- Breast feeding females
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University/Sidney Kimmel Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| NYP/Weill Cornell Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.