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Completed

NCT Number: NCT00707408

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

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.

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Key information

Conditions

AML

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nantes University Hopspital

Nantes, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imatinib

Drug

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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2009
First posted
Jun 30, 2008
Registry last updated
Feb 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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