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

This study has been completed.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00707408
First received: June 26, 2008
Last updated: January 30, 2009
Last verified: January 2009
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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: NCT00707408

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

No publications provided

Responsible Party: Dr Patrice Chevallier
ClinicalTrials.gov Identifier: NCT00707408     History of Changes
Other Study ID Numbers: BRD 03/3-B
Study First Received: June 26, 2008
Last Updated: January 30, 2009
Health Authority: France: French Data Protection Authority

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

ClinicalTrials.gov processed this record on August 26, 2014