Safety and Efficacy of Imatinib in Chronic Myelogenous Patients in Relapse After Stem Cell Transplantation
The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase who are in relapse after stem cell transplantation.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial to Study the Tolerability and the Effectiveness of Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase in Relapse After Allogeneic Stem Cell Transplantation|
- - to assess the tolerability of Imatinib given at a daily dose of 400mg
- - to evaluate the hematologic, cytogenetic and molecular responses at various check points.
- - to assess donor/recipient chimerism during Imatinib therapy
- - to evaluate the survival
|Study Start Date:||May 2002|
|Estimated Study Completion Date:||July 2007|
Patients will received Imatinib at a dose of 400mg daily. The tolerability of Imatinib given at a daily dose of 400mg will be assessed. The hematologic, cytogenetic and molecular responses will be evaluated at various check points.
Donor/recipient chimerism during Imatinib therapy will be assessed. Survival will be estimated.
|Poitiers, France, 86021|
|Study Chair:||François GUILHOT, MD||Department of Oncology Hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE|
|Principal Investigator:||Agnès DEVERGIE, MD||University Hospital "Saint-Louis" - Department of Hematology and Oncology - 75475 PARIS Cedex 10 (FRANCE)|