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

Chronic Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00146913
• Other study ID #: 2003.317
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 5, 2005
• Last updated: April 26, 2007
• Start date: March 2004

Study information

• Verified date: April 2007
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase

Intervention

Drug:
• Imatinib mesylate 600mg/day

• Peg-Interféron at 90 microg/week

Locations

Country	Name	City	State
France	Franck NICOLINI	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study the maintenance of a complete hematologic response, the cytogenetic and molecular responses, and the overall survival of the patients population
Secondary	Evaluate the tolerance of a combination of STI571 and alpha-interferon