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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Myeloid Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Imatinib mesylate 600mg/day

Intervention Type DRUG

Peg-Interféron at 90 microg/week

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Mauricette MICHALLET, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Franck NICOLINI

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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2003.317

Identifier Type: -

Identifier Source: org_study_id