Safety and Efficacy of Imatinib in Chronic Myelogenous Patients in Relapse After Stem Cell Transplantation
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|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|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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)|