Overview

This trial is active, not recruiting.

Condition chronic myeloid leukemia
Treatments imatinib mesylate 600mg/day, peg-interféron at 90 microg/week
Phase phase 2
Sponsor Hospices Civils de Lyon
Start date March 2004
Trial size 30 participants
Trial identifier NCT00146913, 2003.317

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label

Primary Outcomes

Measure
Study the maintenance of a complete hematologic response, the cytogenetic and molecular responses, and the overall survival of the patients population
time frame:

Secondary Outcomes

Measure
Evaluate the tolerance of a combination of STI571 and alpha-interferon
time frame:

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in April 2007.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.