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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00146913
Recruitment Status : Unknown
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
First Posted : September 7, 2005
Last Update Posted : April 27, 2007
Information provided by:
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia Drug: Imatinib mesylate 600mg/day Drug: Peg-Interféron at 90 microg/week Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : March 2004

Primary Outcome Measures :
  1. Study the maintenance of a complete hematologic response, the cytogenetic and molecular responses, and the overall survival of the patients population

Secondary Outcome Measures :
  1. Evaluate the tolerance of a combination of STI571 and alpha-interferon

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00146913

Lyon, France, 69437
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Mauricette MICHALLET, MD Hospices Civils de Lyon Identifier: NCT00146913     History of Changes
Other Study ID Numbers: 2003.317
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: April 27, 2007
Last Verified: April 2007

Keywords provided by Hospices Civils de Lyon:
Chronic myeloid leukaemia
Imatinib mesylate

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action