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

NCT00707408 | Completed Phase 2

• 1 other identifier: BRD 03/3-B
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

AML

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• % blasts in bone marrow,
• % 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

You may not qualify if:

• Previous treatment by Imatinib
• Secondary AML

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hopspital

Nantes, 44093, France

Location

MeSH Terms

Interventions

Imatinib Mesylate

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: June 30, 2008
• Study Start: February 1, 2004
• Study Completion: January 1, 2009
• Last Updated: February 2, 2009

Record last verified: 2009-01

Locations

FR (1)