Status:
WITHDRAWN
Autologous Stem Cell Transplants for Chronic Myelogenous Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
Brief Summary
Primary Objective: 1\. To study ex-vivo purging of autologous hematopoietic stem cells that will be used to support high-dose chemotherapy in patients with chronic myelogenous leukemia (CML). Major e...
Detailed Description
Before treatment starts, you will have a complete physical exam. You will have about 4 tablespoons of blood drawn for tests to check on the status of the disease, to check organ functions, and to chec...
Eligibility Criteria
Inclusion
- Patients with Philadelphia (Ph) chromosome positive CML \< age 65 and older than 21 years.
- Ph positive CML that is either in: 1. late 1st chronic phase (\> 2 years from diagnosis) 2. early chronic phase who did not achieve complete cytogenetic remission after one year on imatinib 3. beyond first chronic phase 4. accelerated phase 5. blastic phase that has responded to therapy (characterized by the presence of \< 10% bone marrow and/or circulating blasts at consent signing) 6. chronic phase, developing imatinib resistance (loss of molecular remission defined as at least a 1 log increase in the BCR-ABL/ABL ratio, in 2 time points at least 1 month apart, or loss of cytogenetic remission)
- Patients must have a Zubrod PS \< 3. Creatinine \< 1.8 mg/dl
- Serum bilirubin \</= 1.5 mg/dl
- Serum glutamate pyruvate transaminase (SGPT) \< 3 x normal values
- Patients with an HLA identical sibling are eligible if they refuse allogeneic transplantation, or if they are ineligible for allogeneic transplantation due to age.
- DLCO \>/= 50% of predicted
- Cardiac Ejection fraction \>/= 40%
Exclusion
- Uncontrolled life-threatening infections or comorbid condition that could impair tolerance to the regimen.
- HIV positivity.
- Pregnant or lactating women.
- CML in blastic phase that has not responded to therapy given prior to enrollment in this study (characterized by the presence of more than 9% bone marrow and/or peripheral blood blasts at the time of consent signing)
- Hepatitis B or C virus infection. Hepatitis B infection defined by positive DNA test, positive E and / or surface antigen.
- CML in first molecular remission.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00446173
Start Date
March 1 2007
End Date
January 1 2009
Last Update
August 25 2015
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030