NCT00146913

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Imatinib mesylate 600mg/day
DRUG	Peg-Interféron at 90 microg/week

Timeline

• Start date: 2004-03-01
• First posted: 2005-09-07
• Last updated: 2007-04-27

Locations

1 site across 1 country: France