Imatinib Mesylate, Busulfan, Fludarabine, and Antithymocyte Globulin for CML Patients
Stopped early · Phase 2
Conditions studied: Leukemia
In brief
Primary Objective: To estimate the probability of molecular complete remission at one year for the described sequential treatment approach, with nonablative hematopoietic transplantation, post transplant imatinib mesylate and donor lymphocyte infusion, in patients with Ph-positive Chronic Myelogenous Leukemia (CML) not in blastic transformation. Secondary Objective: Response to post transplant Imatinib mesylate therapy for 12 weeks as treatment of residual disease, response to donor lymphocyte infusion (DLI) for residual disease following imatinib mesylate therapy, as well as engraftment, toxicity, disease free survival and survival, effect of busulfan pharmacokinetics on study outcome.
Key facts
- Study ID
- NCT00499889
- Run by
- M.D. Anderson Cancer Center
- People needed
- 42
- Starts
- 2003-02-01
- Expected to finish
- 2009-11-01
- Last updated by the study team
- 2012-04-23
Who can join
Age: any, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of Ph+ chronic myelogenous leukemia (CML) in first chronic phase without a complete hematologic response after 3 months of Imatinib mesylate therapy, or >=35% Ph+ cells despite > 6 months of Imatinib mesylate treatment, or after disease progression from a complete or partial response. Any patient with accelerated phase or blast crisis who achieves a subsequent chronic phase is eligible. Patients must have an HLA matched related or unrelated donor or one antigen mismatched related donor.
- Patients should be less than 70 years of age. Patients less than 30 years of age who achieve a hematologic remission with imatinib therapy are eligible regardless of cytogenetic response.
- Patients are stratified as Group 1: First chronic phase, Group 2 Accelerated phase or blast crisis that achieved a hematologic remission with imatinib mesylate-based treatment.
You may not qualify if…
- Zubrod Performance Scale (PS) >=2, uncontrolled infection, Creatinine > 2.0 mg/dl; Ejection fraction < 40%; Carbon Monoxide Diffusing Capacity (DLCO) < 45% of predicted; Serum bilirubin > 2 gm/dl; GPT (Glutamic-pyruvic transaminase) or GOT (glutamic-oxaloacetic transaminase)> 3 times normal values. Patients should not be human immunodeficiency virus (HIV) seropositive or pregnant.
- Patients should not have progressed to accelerated phase or blast crisis while receiving imatinib mesylate containing therapy.
Where it is running
- UT MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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