Autologous Transplantation for Chronic Myelogenous Leukemia

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Busulfan; Cyclophosphamide; Imatinib Mesylate

Criteria

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.