Status:
COMPLETED
Autologous Transplantation for Chronic Myelogenous Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Chronic Myelogenous Leukemia
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE2
Brief 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 mesyla...
Detailed Description
Busulfan and cyclophosphamide are chemotherapy drugs which were designed to kill leukemia cells. An autologous bone marrow transplant is given after treatment with busulfan and cyclophosphamide to hel...
Eligibility Criteria
Inclusion
- 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.
- 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).
- Cytogenetic relapse (as above) with hematologic remission or chronic phase disease, or
- Accelerated phase or second or subsequent chronic phase.
- 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.
- Age \< 70 years.
- Zubrod PS \<=2.
- Creatinine \< 1.8 mg/dL.
- Cardiac ejection fraction \> 40%.
- DLCO \> 50% of the predicted value.
- Serum bilirubin \< 1.5 mg/dL.
- SGPT \< 3 x normal values.
- Patients with an HLA identical sibling are eligible if they refuse allogeneic transplantation.
Exclusion
- Uncontrolled life-threatening infections or comorbid condition that could impair tolerance to the regimen.
- HIV positivity.
- Pregnant or lactating women.
- Blast crisis (\>30% blasts in blood or marrow)
- Hepatitis B or C positivity.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01003054
Start Date
March 1 2005
End Date
October 1 2009
Last Update
November 2 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77070