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

AML Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707408
• Other study ID #: BRD 03/3-B
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2008
• Last updated: January 30, 2009
• Start date: February 2004
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AML
• Leukemia, Myeloid, Acute

Intervention

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.

Locations

Country	Name	City	State
France	Nantes University Hopspital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France,