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

Sponsored by:	Nantes University Hospital
Information provided by:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT00707408

Purpose

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.

Condition	Intervention	Phase
AML	Drug: Imatinib	Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Nantes University Hospital:

Enrollment:	15
Study Start Date:	February 2004

Intervention Details:

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.

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707408

Locations

France
Nantes University Hopspital
Nantes, France, 44093

Sponsors and Collaborators

Nantes University Hospital

More Information

Responsible Party:	( Dr Patrice Chevallier )
Study ID Numbers:	BRD 03/3-B
Study First Received:	June 26, 2008
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00707408
Health Authority:	France: French Data Protection Authority

Study placed in the following topic categories:

Imatinib
Leukemia
Acute myelogenous leukemia

Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009