Imatinib Mesylate After a Donor Stem Cell Transplant in Treating Patients With Philadelphia Chromosome-Positive Leukemia

Study Overview
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Brief Summary
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RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate after a donor stem cell transplant may prevent the recurrence of Philadelphia chromosome-positive leukemia. PURPOSE: This phase I/II trial is studying the side effects of giving imatinib mesylate after a donor stem cell transplant and to see how well it works in treating patients with Philadelphia chromosome-positive leukemia.

Detailed Description
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OBJECTIVES: Primary Determine the safety of adjuvant imatinib mesylate after allogeneic hematopoietic stem cell transplantation (AHSCT) in patients with high-risk Philadelphia chromosome-positive leukemia. Secondary Determine the bcr/abl transcript load during the first 90 days after AHSCT in patients treated with this drug from the time of engraftment. Determine the 1-year survival of patients treated with this drug. OUTLINE: This is an open-label, pilot, multicenter study. Beginning within 14-30 days after allogeneic stem cell transplantation, patients receive oral imatinib mesylate once daily until 1 year after transplantation. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed for survival. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Official Title
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A Multicenter Pilot Study Evaluating the Safety and Efficacy of Imatinib as Post-Transplant Therapy for High- Risk Philadelphia Chromosome-Positive Leukemias

Conditions
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Leukemia

Intervention / Treatment
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* Drug: imatinib mesylate
* Procedure: adjuvant therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of 1 of the following: Acute lymphoblastic leukemia or chronic myeloid leukemia (CML) characterized by p^190 and/or p^210 bcr/abl gene rearrangement Accelerated or blastic phase CML CML in second or greater chronic phase No imatinib mesylate-resistant leukemia Planned allogeneic hematopoietic stem cell transplantation Availability of an appropriately matched related or unrelated donor Autologous or nonmyeloablative transplantation is not allowed None of the following within 4 days after the date of neutrophil engraftment*: More than 5% marrow blasts Circulating peripheral blood leukemic blasts Aberrant antigen expression on marrow myeloblasts ≥ 1% by multidimensional flow cytometric assay Presence of bcr/abl in > 5% of marrow interphase nuclei by fluorescent in situ hybridization More than 1 of 20 Philadelphia chromosome-positive marrow metaphases CNS involvement by leukemia NOTE: *The date of neutrophil engraftment is defined as the second consecutive day at which the peripheral blood absolute neutrophil count exceeds 500/mm3 PATIENT CHARACTERISTICS: Performance status Not specified Life expectancy At least 2 months Hematopoietic See Disease Characteristics Absolute neutrophil count ≥ 1,200/mm^3 (use of filgrastim [G-CSF] allowed) Hepatic Not specified Renal Not specified Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known imatinib mesylate hypersensitivity No other disease that severely limits life expectancy PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: imatinib mesylate|nan|
|Procedure: adjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety at 90 days following transplant |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCR/ABL transcript load at 90 days following transplant |  |  | 
| Standard management of progressive minimal residual disease at 90 days following transplant |  |  | 
| Survival at 1 year |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, childhood chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia, adult acute lymphoblastic leukemia in remission, childhood acute lymphoblastic leukemia in remission