Clinical trial · Interventional
Autologous Transplantation for Chronic Myelogenous Leukemia
Busulfan, Cyclophosphamide, Imatinib Mesylate and Autologous Stem Cell Transplantation in Patients With Chronic Myelogenous Leukemia
- 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 is to learn if treatment with high-dose busulfan and cyclophosphamide plus autologous bone marrow transplantation followed by treatment with Gleevec (imatinib mesylate) is effective in treating chronic myelogenous leukemia (CML). Objectives: 1. To assess the efficacy of high dose busulfan-cyclophosphamide and autologous hematopoietic transplantation with post transplant Imatinib mesylate for the treatment of CML. The primary endpoint of the study is to determine the proportion of patients with CML alive in cytogenetic remission at one year following this treatment. 2. Secondary endpoints are time to progression and survival.
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 |
|---|---|---|---|
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Busulfan | Drug | Busulfan | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Imatinib Mesylate | Drug | Imatinib Mesylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous Transplantation
- description
- Busulfan 130 mg/m\^2 intravenous (IV) every 24 hours Days -7 to -4; Cyclophosphamide 60 mg/kg over 4 hours Day -3 and -2; Imatinib Mesylate Starting dose 100 mg/day, and Autologous Stem Cell Transplantation on Day 0.
- interventionNames
- Drug: Busulfan
- Drug: Cyclophosphamide
- Drug: Imatinib Mesylate
- Procedure: Autologous Stem Cell Transplantation
Primary outcomes (1)
- measure
- Number of participants with CML alive in cytogenetic remission at one year following treatment
- timeFrame
- Baseline to 1 Year post treatment, up to 18 months
- description
- Cytogenetic complete remission confirmed via bone marrow examination for morphology, cytogenetics or Fluorescence in situ hybridization (FISH).
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Criteria for hematopoietic stem cell collection and cryopreservation: a- Patients with Philadelphia chromosome positive CML \< age 70 who achieve a cytogenetic remission (no Ph+ cells on bone marrow cytogenetics, at least twenty metaphases counted) are eligible for hematopoietic stem cell collection and cryopreservation. b- Patients must have a Zubrod PS \<2. c.Creatinine \< 1.8 mg/dl d.Serum bilirubin \< 1.5 mg/dl e. SGPT \< 3 x normal values f. Patients with an HLA identical sibling are eligible if they refuse allogeneic transplantation. 2. Patients are eligible for high dose therapy and autologous transplantation if they meet the following criteria (numbered 2-13): - Cytogenetic relapse characterized by \> 10% Ph+ metaphases (by FISH analysis or \> 2 of 20 Ph+ metaphases on 2 consecutive cytogenetic studies at least 1 month apart). 3. Cytogenetic relapse (as above) with hematologic remission or chronic phase disease, or 4. Accelerated phase or second or subsequent chronic phase. 5. Availability of stored autologous hematopoietic stem cells collected when the patient was in cytogenetic complete remission (0 of \>= 20 metaphases positive for Ph+ cells).A minimum of 0.5 x 10 6 CD34 positive cells/kg or 1 x 10 8 total nucleated cells/Kg must be available. 6. Age \< 70 years. 7. Zubrod PS \<=2. 8. Creatinine \< 1.8 mg/dL. 9. Cardiac ejection fraction \> 40%. 10. DLCO \> 50% of the predicted value. 11. Serum bilirubin \< 1.5 mg/dL. 12. SGPT \< 3 x normal values. 13. Patients with an HLA identical sibling are eligible if they refuse allogeneic transplantation. Exclusion Criteria: 1. Uncontrolled life-threatening infections or comorbid condition that could impair tolerance to the regimen. 2. HIV positivity. 3. Pregnant or lactating women. 4. Blast crisis (\>30% blasts in blood or marrow) 5. Hepatitis B or C positivity.
References
Publications (0)
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