Status:
WITHDRAWN
PR1-Specific Cytotoxic T-Lymphocyte Infusion With Recurrent Chronic Myelogenous Leukemia (CML) After Allogeneic Hematopoietic Transplantation
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Chronic Myelogenous Leukemia
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
Primary Objective: To determine the maximally tolerated dose of donor PR1-specific cytotoxic T-lymphocytes (PR1-CTL) as treatment for relapsed or persistent chronic myelogenous leukemia (CML) after a...
Detailed Description
Before treatment starts, you will have a complete physical exam, including blood (about 2 tablespoons) tests. You will have a chest x-ray and bone marrow will be collected. To collect a bone marrow sa...
Eligibility Criteria
Inclusion
- Patients with chronic myelogenous leukemia (CML) who have previously undergone allogeneic hematopoietic transplantation and have evidence of disease, as defined by a,b or c (a) \>5% Philadelphia chromosome positive cells on cytogenetic studies \>/= 3 months post-transplant
- (b) For patients in cytogenetic remission post-transplant, molecular evidence of disease at any time, defined as recurrence of quantitative PCR positivity for bcr-abl after achieving a molecular remission confirmed by 2 assays, 3 months apart or sooner if clinically indicated; OR a \>10-fold increase in the relative expression of bcr-abl/abl detected and confirmed by a minimum of 2 consecutive PCR analysis, 3 months apart or sooner
- (c) Molecular evidence of persistent disease on Real time PCR (bcr-abl/ abl x 100 of 0.05 and not declining) \>3 months post-transplantation after treatment with imatinib mesylate.
- Patients must have an HLA compatible related or unrelated donor capable of donating peripheral blood stem cells using apheresis techniques. This must be the same donor used for the original allogeneic hematopoetic transplantation. Patient must be HLA-A2 positive
- ECOG performance status \< or = 2
- Serum bilirubin \< or = 2 mg/dl
- Serum transaminases \< 4 x normal
- Serum creatinine \< or = 2 mg/dl
- No active uncontrolled infection
- HIV negative
- No acute and/or chronic GVHD requiring systemic steroid therapy
- Patient is not pregnant or breast feeding.
- Signed informed consent
- Patients must be off all immunosuppressive medications for at least 2 weeks prior to study entry.
Exclusion
- None.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00866346
Start Date
March 1 2008
Last Update
March 4 2014
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