Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine (AZA) Days 1 - 3 | Drug | — | UNRESOLVED |
| Azacitidine (AZA) Days 1 - 5 | Drug | — | UNRESOLVED |
| Best Supportive Care (BSC) | Other | — | UNRESOLVED |
| Decitabine (DAC) | Drug | Decitabine | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Azacitidine (AZA) - Days 1 - 3
- description
- Azacitidine (AZA) Azacitidine 75 mg/m2 by vein or subcutaneously daily for 3 days (days 1-3) approximately every 28 days.
- interventionNames
- Drug: Azacitidine (AZA) Days 1 - 3
- type
- EXPERIMENTAL
- label
- Azacitidine (AZA) - Days 1 - 5
- description
- Azacitidine (AZA) 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.
- interventionNames
- Drug: Azacitidine (AZA) Days 1 - 5
- type
- EXPERIMENTAL
- label
- Decitabine (DAC)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Sign an IRB-approved informed consent document. 2. Age \>/= 18 years. 3. IPSS low- or intermediate-1-risk MDS, including CMML-1 4. ECOG performance status of \</= 3 at study entry. 5. Organ function defined as: Serum creatinine \</= 2 mg/dL; Total bilirubin \</= 2 x ULN; ALT (SGPT) \</= 2 x ULN; AST (SGOT) \</= 2 x ULN 6. 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: 1. Breast feeding females 2. Prior therapy with decitabine or azacitidine
References
Publications (0)
Data not yet available