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High-Dose Imatinib for Relapsed/Refractory c-Kit Positive Acute Myelogenous Leukemia (AML)

Sponsor
Nantes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00707408
Collaborator
(none)
15
Enrollment
1
Location
59
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multicenter open-label phase II trial of high dose imatinib mesylate in patients with AML in first or second relapse, or with refractory disease. Daily dosing of imatinib 600 mg/day is planned for one month or until progression of disease. Dose increase to 800 mg/ day imatinib is permitted for 2 additional months in the event of response failure. Response is assessed after 1, 2 and 3 months of treatment by bone marrow aspirate.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Daily dosing of imatinib 600 mg/day is planned for one month or until progression of disease. Dose increase to 800 mg/ day imatinib is permitted for 2 additional months in the event of response failure. Novartis provided supplies of imatinib for all patients included in the study.

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial Evaluating the Safety and the Efficacy of High-Dose Imatinib in Relapsed/Refractory c-Kit Positive and BCR-Abl Negative AML Patients
Study Start Date :
Feb 1, 2004
Actual Study Completion Date :
Jan 1, 2009

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age > 18 years,

    • AML in first or second relapse,

    • refractory AML

    • performance status of 0-2 on the Eastern Cooperative Oncology Group scale,

    • adequate hepatic and renal functions (AST or ALT <= 5 times the upper limit of normal

    • creatinine < 2 times the upper limit of normal)

    • 20% blasts in bone marrow,

    • 70% of bone marrow blast population c-kit positive as assessed by immunophenotyping

    • Bcr-Abl negative chromosomal analysis (assessed by fluorescence in situ hybridization; FISH), and no chromosome 5-12 translocation

    Exclusion Criteria:

    • Previous treatment by Imatinib

    • Secondary AML

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nantes University Hopspital Nantes France 44093

    Sponsors and Collaborators

    • Nantes University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00707408
    Other Study ID Numbers:
    • BRD 03/3-B
    First Posted:
    Jun 30, 2008
    Last Update Posted:
    Feb 2, 2009
    Last Verified:
    Jan 1, 2009
    Additional relevant MeSH terms:
    Imatinib Mesylate

    Study Results

    No Results Posted as of Feb 2, 2009