Safety and Efficacy of Imatinib in Chronic Myelogenous Patients in Relapse After Stem Cell Transplantation
|ClinicalTrials.gov Identifier: NCT00219726|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : August 29, 2012
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloid Leukemia||Drug: Imatinib mesylate||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2002|
|Estimated Study Completion Date :||July 2007|
- - 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)|