AFR10 - Combination Therapy of Imatinib Mesylate (IM) + Alpha-2A Interferon for Chronic Phase CML Patients Resistant or Refractory to IM Used as Single Therapy for at Least One Year

Study Overview
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Brief Summary
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Sixty % of CML patients treated by Imatinib mesylate achieved a major cytogenetic responses (CCR) at 18 months. So, 40% of the patients must receive additional treatment. In vitro, it has been shown that IM and Interféron-alpha have synergic anti-proliferative effect on chromosome Ph+ cell lines. By using Peg-Interféron and IM combination, we hope to increase the cytogenetic response of patients.

Official Title
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A Phase II Study Evaluating the Efficacy and Tolerance of Combination Therapy of Imatinib Mesylate (IM) +-2A Interféron for Chronic Phase CML Patients Resistant or Refractory to IM Used as Single Therapy for at Least One Year

Conditions
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Chronic Myeloid Leukemia

Intervention / Treatment
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* Drug: Imatinib mesylate 600mg/day
* Drug: Peg-Interféron at 90 microg/week


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic phase Philadelphia positive CML, confirmed by karyotyping (or FISH) analysis, in complete hematologic response with IM. Lack of major cytogenetic response after at least one year of STI 571 as single therapy. Male and female * 18 years old. Informed consent signed up. Performance status grade 0 - 2 (ECOG). SGOT and SGPT <3N Serum bilirubin < 1.5 N Serum creatinine < 1.5 N No HSC graft planned B-HCG negative for female with potential childbearing Exclusion Criteria: Absence of complete hematologic response Extramedullar involvement Previous extra-hematologic intolerance of Interféron at a dose superior or equal to 25 MUI/week Depressive syndrome not controlled Not controlled dysthyroidy Auto-immune pathology not controlled Women with childbearing potential who are unwilling or unable to use an adequate method to avoid pregnancy for the entire period of the study Significant cardiac disease (grade 3 or more) Known seropositivity for HIV Active viral hepatitis Other malignant disease Other experimental medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

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

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Imatinib mesylate 600mg/day|nan|
|Drug: Peg-Interféron at 90 microg/week|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study the maintenance of a complete hematologic response, the cytogenetic and molecular responses, and the overall survival of the patients population |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the tolerance of a combination of STI571 and alpha-interferon |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic myeloid leukaemia, resistant, refractory, Imatinib mesylate