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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00707408
First Posted: June 30, 2008
Last Update Posted: February 2, 2009
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:
Nantes University Hospital
  Purpose
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 Intervention Phase
AML Drug: Imatinib Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Enrollment: 15
Study Start Date: February 2004
Study Completion Date: January 2009
Intervention Details:
    Drug: Imatinib
    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.
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.
  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:

  • 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
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): NCT00707408


Locations
France
Nantes University Hopspital
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
  More Information

Responsible Party: Dr Patrice Chevallier
ClinicalTrials.gov Identifier: NCT00707408     History of Changes
Other Study ID Numbers: BRD 03/3-B
First Submitted: June 26, 2008
First Posted: June 30, 2008
Last Update Posted: February 2, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action