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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


Phase 2
18 Years
90 Years
Not Enrolling
Both
AML

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Authority:

France: French Data Protection Authority

Study ID:

BRD 03/3-B

NCT ID:

NCT00707408

Start Date:

February 2004

Completion Date:

January 2009

Related Keywords:

  • AML
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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