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Study Summary
No. ID02-901:.......Blood And Marrow Transplantation......Richard E. Champlin......Stem Cell Transplantation and Cellular Therapy
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Study Summary Title
Study Summary
Number:		ID02-901
Study Title:IMATINIB MESYLATE, BUSULFAN, FLUDARABINE, ATG AND ALLOGENEIC STEM CELL TRANSPLANTATION FOR CHRONIC MYELOGENOUS LEUKEMIA
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Physician New Patient Referral
Name:Richard E. ChamplinPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Stem Cell Transplantation and Cellular TherapyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-8750
Contact us about clinical trials
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General Information
Disease Group:Blood And Marrow TransplantationSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		Patients are followed continuously at MDACC until 100 days post transplant then
q 3 mo for one year and yearly for 5 years.
Treatment
Agents:		Antithymocyte Globulin
Busulfan
Etidronate Disodium		Home Care:none required, but home care may be used for supportive care if clinically
indicated
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		average 28 days
Description/
Intervention:		The goal of this clinical research study is to learn if using a combination of
imatinib mesylate, (Gleevec), fludarabine, busulfan, and antithymocyte globulin
(ATG) in patients receiving a bone marrow or blood stem cell transplantation
can help to control CML.
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Study Objectives / Outcomes
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 CML not in blastic transformation

Secondary endpoints include response to post transplant Imatinib mesylate therapy for 12 weeks as treatment of residual disease, response to 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.
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Study Status Information
Study Activation / Registration Date:02/12/2003
IRB Review and Approval Date:01/15/2003
Study Type:Therapeutic
Recruitment Status:Terminated
Projected Accrual:90
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Diagnosis of Ph+ 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.

2) 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.

3) 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.
Exclusion Criteria:1) Zubrod PS >=2, uncontrolled infection, Creatinine > 2.0 mg/dl; Ejection fraction < 40%; DLCO < 45% of predicted; Serum bilirubin > 2 gm/dl; elevated GPT or GOT > 3 x normal values. Patients should not be HIV seropositive or pregnant.

2) Patients should not have progressed to accelerated phase or blast crisis while receiving imatinib mesylate containing therapy.
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Links
Registration Number: NCT00499889
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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