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

Phase 2

• Conditions: Chronic Myeloid Leukemia

• Registration Number: NCT00146913
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2005-09-05
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-07
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-26
• Last Update Posted: 2007-04-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Study the maintenance of a complete hematologic response, the cytogenetic and molecular responses, and the overall survival of the patients population

Secondary Outcome Measures

Name	Time	Method
Evaluate the tolerance of a combination of STI571 and alpha-interferon

Trial Locations

Locations (1)

Franck NICOLINI; 🇫🇷 Lyon, France