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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00146913
First Posted: September 7, 2005
Last Update Posted: April 27, 2007
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.
Information provided by:
Hospices Civils de Lyon
  Purpose
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 Intervention Phase
Chronic Myeloid Leukemia Drug: Imatinib mesylate 600mg/day Drug: Peg-Interféron at 90 microg/week Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

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

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

Estimated Enrollment: 30
Study Start Date: March 2004
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00146913


Locations
France
Franck NICOLINI
Lyon, France, 69437
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Mauricette MICHALLET, MD Hospices Civils de Lyon
  More Information

ClinicalTrials.gov Identifier: NCT00146913     History of Changes
Other Study ID Numbers: 2003.317
First Submitted: September 5, 2005
First Posted: September 7, 2005
Last Update Posted: April 27, 2007
Last Verified: April 2007

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

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