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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

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Civil Hospices of Lyon

Status and phase

Unknown
Phase 2

Conditions

Chronic Myeloid Leukemia

Treatments

Drug: Imatinib mesylate 600mg/day
Drug: Peg-Interféron at 90 microg/week

Study type

Interventional

Funder types

Other

Identifiers

NCT00146913
2003.317

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 90 years old

Volunteers

No 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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