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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospices Civils de Lyon
• Treatments: Imatinib Mesylate; Interferons

Criteria

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