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

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 2

Conditions: AML

Treatments: Drug: Imatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT00707408

BRD 03/3-B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)