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

NCT00146913 | Unknown Phase 2

• 1 other identifier: 2003.317
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Myeloid Leukemia

Keywords

Chronic myeloid leukaemia; resistant; refractory; Imatinib mesylate

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• Evaluate the tolerance of a combination of STI571 and alpha-interferon

Interventions

Imatinib mesylate 600mg/day DRUG

Peg-Interféron at 90 microg/week DRUG

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Franck NICOLINI

Lyon, 69437, France

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Mauricette MICHALLET, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 5, 2005
• First Posted: September 7, 2005
• Study Start: March 1, 2004
• Last Updated: April 27, 2007

Record last verified: 2007-04

Locations

FR (1)