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 because the information has not been verified recently.
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00146913
First received: September 5, 2005
Last updated: April 26, 2007
Last verified: April 2007
  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: 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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00146913     History of Changes
Other Study ID Numbers: 2003.317
Study First Received: September 5, 2005
Last Updated: April 26, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on October 30, 2014