Autologous Stem Cell Transplants for Chronic Myelogenous Leukemia

• Status: Withdrawn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

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 endpoints are neutrophil engraftment and survival.

Secondary Objectives:

1. To evaluate the toxicity of ex-vivo purged autologous cells when used to support high-dose chemotherapy.

2. To evaluate the rate and duration of cytogenetic remissions achieved with this strategy.

3. To determine the time to platelet recovery to 20,000/mm3.

4. To determine the one-year survival rate.

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

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Busulfan; Cyclophosphamide; Sargramostim

Criteria

Inclusion Criteria:

• 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
• 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 Criteria:

• 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.