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
This trial is active, not recruiting.
|Condition||chronic myeloid leukemia|
|Treatments||imatinib mesylate 600mg/day, peg-interféron at 90 microg/week|
|Sponsor||Hospices Civils de Lyon|
|Start date||March 2004|
|Trial size||30 participants|
|Trial identifier||NCT00146913, 2003.317|
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.
|Intervention model||single group assignment|
Study the maintenance of a complete hematologic response, the cytogenetic and molecular responses, and the overall survival of the patients population
Evaluate the tolerance of a combination of STI571 and alpha-interferon
Male or female participants from 18 years up to 90 years old.
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
|Official title||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|
|Principal investigator||Mauricette MICHALLET, MD|
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