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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00146913

Enrollment

Registered

2005-09-07

Start date

2004-03-31

Completion date

Unknown

Last updated

2007-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia

Keywords

Chronic myeloid leukaemia, resistant, refractory, Imatinib mesylate

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.

Interventions

DRUGImatinib mesylate 600mg/day

DRUGPeg-Interféron at 90 microg/week

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Evaluate the tolerance of a combination of STI571 and alpha-interferon	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026