Clinical trial · Interventional
Azacitidine Maintenance Therapy After Allogeneic Bone Marrow Transplantation (Allo BMT)
Azacitidine Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for AML and MDS
NCT00350818CI-TRIAL-00007621completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Primary Objective: -To determine the dose and schedule combination of 5-Azacitidine, when used as maintenance treatment after allogeneic transplantation for high-risk AML / MDS. Secondary Objective: -To assess the effect of treatment on survival after allogeneic transplantation for high-risk AML / MDS.
Conditions
Conditions (2)
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 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Azacitidine
- description
- Azacitidine after Allogeneic Transplantation
- interventionNames
- Drug: Azacitidine
Primary outcomes (1)
- measure
- Time to Toxicity
- timeFrame
- Baseline with 30 day cycles (up to 4 cycles), approximately 116 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with a diagnosis of AML (WHO classification: \>=20% blasts in the bone marrow and / or peripheral blood), or MDS (IPSS intermediate-2 or higher) that at the time of allogeneic transplantation were in. 2. Induction Failure, relapsed disease or second or greater remission. 3. Patients in first complete remission that required more than 2 cycles of treatment to achieve the remission. 4. Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch) or 5. HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen mismatch) 6. Age 18 to 75 years and 7. Left ventricular ejection fraction \>40% and 8. FEV1, FVC and DLCO \>40% and 9. Serum creatinine \<1.6 mg/dL and 10. Serum bilirubin \< 1.6 mg/dL and 11. SGPT \< 3 X upper limit of normal and 12. All patients and donors or guardian should be able to understand and sign informed consent. 13. Women of childbearing potential (any female who has experienced menarche, and who has not undergone surgical sterilization or is not post-menopausal) must have a negative serum pregnancy test. Exclusion Criteria: 1. HIV positive 2. AML or MDS in first complete remission (defined as: bone marrow with less than 6% blasts, no circulating blasts, and a platelet count greater than 100,000 /mm\^3.) 3. Active uncontrolled infection 4. Pregnancy or breastfeeding
References
Publications (0)
Data not yet available
No reference posted for this study.