Safety and Efficacy of Imatinib in Chronic Myelogenous Patients 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219726
|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)|