Clinical trial · Interventional
Azacitidine After Allo Blood And Marrow Transplantation (BMT) for Chronic Myelogenous Leukemia (CML)
Azacitidine Maintenance Therapy After Allogeneic Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML)
NCT00813124CI-TRIAL-00050026completedPhase 2Results postedClinicalTrials.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)
The goal of this clinical research study is to learn if Vidaza (azacitidine) when given to patients with CML after an donor stem cell transplant will increase the likelihood of achieving a complete remission of CML.
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 |
| Stem Cell Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Busulfan | Drug | Busulfan | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Stem Cell Transplant | Procedure | — | UNRESOLVED |
| Thymoglobulin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Azacytidine Maintenance after allotx
- description
- Busulfan + Fludarabine + ATG + Azacytidine after allogeneic stem cell transplantation (allotx)
- interventionNames
- Drug: Fludarabine
- Drug: Busulfan
- Drug: Thymoglobulin
- Drug: Azacitidine
- Procedure: Stem Cell Transplant
Primary outcomes (1)
- measure
- Number of Participants With Molecular Response
- timeFrame
- 12 month post BMT
- description
- Molecular Remission defined as two consecutive bone marrow samples done one month apart with negative PCR( polymerase chain reaction) tor CML.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with age \<= 75 years with CML in first chronic phase, which has failed to achieve a cytogenetic or molecular complete remission or has progressed after imatinib treatment. Criteria for failure are the international consensus criteria (Appendix H). Patients intolerant to tyrosine kinase inhibitor therapy are also eligible. 2. Patients with age \<= 75 with CML in accelerated phase or blast crisis that have \<= 15% blasts in the blood and bone marrow at study entry. 3. Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch) or HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen mismatch). 4. Age 18 to 75 years. 5. Zubrod performance status \<= 2. 6. Left ventricular ejection fraction =\> 40%. 7. Pulmonary function test within the following parameters: forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) =\> 50% of expected, corrected for hemoglobin. 8. Serum creatinine \< 1.5 mg/dL or creatinine clearance greater or equal than 40 cc/min. 9. Serum direct bilirubin \< 1.5 mg/dL (unless Gilbert's syndrome) 10. Serum glutamate pyruvate transaminase (SGPT) \<= 200 IU/L unless related to patient's malignancy. 11. Patients treated with any tyrosine kinase inhibitor, interferon or any experimental therapy are eligible. 12. Patients with age \<75 years with CML in second or subsequent chronic phase. Exclusion Criteria: 1. Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. 2. Pleural/pericardial effusion or ascites estimated to be \>1L. 3. HIV-positive. 4. Breast feeding or pregnancy. Pregnancy means a positive beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization. 5. Known or suspected hypersensitivity to azacitidine or mannitol. 6. Patients with advanced malignant hepatic tumors.
References
Publications (0)
Data not yet available
No reference posted for this study.