Interferon Alfa and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia

Study Overview
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Brief Summary
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RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining interferon alfa with imatinib mesylate may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining interferon alfa with imatinib mesylate in treating patients who have chronic myelogenous leukemia.

Detailed Description
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OBJECTIVES: Determine whether interferon alfa in combination with imatinib mesylate adds to the hematologic, cytogenetic, and molecular response rates in patients with chronic phase chronic myelogenous leukemia that is newly diagnosed or has not achieved a complete cytogenetic response to imatinib mesylate alone. OUTLINE: Patients receive oral imatinib mesylate (STI-571) once daily for 9 months. At 9 months, patients with more than 35% Philadelphia chromosome-positive (Ph+) cells in bone marrow receive oral STI-571 twice daily for 3 more months. At 12 months, patients with more than 35% Ph+ cells in bone marrow receive oral STI-571 once daily and interferon alfa subcutaneously once daily. Treatment continues for at least 1 year in the absence of disease progression or unacceptable toxicity. Patients with an appropriate HLA-matched donor may choose to have a bone marrow transplantation at any time during the study. Patients are followed every 6 months for 3 years. PROJECTED ACCRUAL: A total of 80 patients (60 without an HLA-matched donor and 20 with an HLA-matched donor) will be accrued for this study within 5 years.

Official Title
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A Phase II Open Label Study to Determine Safety and Efficacy of Interferon-alpha in Combination With Imantinib Mesylate (Gleevec) in Patients With Chronic Phase Chronic Myelogenous Leukemia Who Have Not Achieved a Complete Cytogenetic Response to Gleevec as a Single Agent

Conditions
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Leukemia

Intervention / Treatment
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* Biological: recombinant interferon alfa
* Drug: imatinib mesylate


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of chronic phase chronic myelogenous leukemia Cytogenetically confirmed Philadelphia chromosome-positive disease or other variant of t(9;22) No secondary chromosomal abnormalities No more than 10% blasts in bone marrow Newly diagnosed OR Received prior imatinib mesylate as a single agent for no more than the past 9 months without achieving a complete cytogenetic response No evidence of extramedullary involvement except nodes, liver, or spleen PATIENT CHARACTERISTICS: Age Any age Performance status ECOG 0-3 Life expectancy Not specified Hematopoietic Platelet count greater than 100,000/mm^3 Absolute neutrophil count greater than 1,500/mm^3 Hepatic Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT no greater than 2 times ULN INR no greater than 1.5 times ULN* PTT no greater than 1.5 times ULN* NOTE: * Except patients on anticoagulants Renal Creatinine no greater than 2 times ULN Other Considered potentially reliable No history of noncompliance to medical regimens No other active malignancy requiring chemotherapy or radiotherapy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier-method contraception during and for at least 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy No prior interferon therapy No prior stem cell or bone marrow transplantation Chemotherapy No prior chemotherapy (except hydroxyurea and/or anagrelide to control counts) Endocrine therapy Not specified Radiotherapy Not specified Surgery At least 4 weeks since prior major surgery and recovered Other No concurrent grapefruit juice or grapefruit products No concurrent warfarin Concurrent low-molecular weight heparin allowed
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 |
| --- |
|Biological: recombinant interferon alfa|nan|
|Drug: imatinib mesylate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic myelogenous leukemia, BCR-ABL1 positive, chronic phase chronic myelogenous leukemia, childhood chronic myelogenous leukemia