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

Nantes University Hospital15 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

AML

Interventions

ImatinibDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Nantes University Hopspital

Nantes, France

Data from ClinicalTrials.gov

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