Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Poitiers University Hospital Novartis |
---|---|
Information provided by: | Poitiers University Hospital |
ClinicalTrials.gov Identifier: | NCT00219726 |
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.
Condition | Intervention | Phase |
---|---|---|
Chronic Myeloid Leukemia |
Drug: Imatinib mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | May 2002 |
Estimated Study Completion Date: | June 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: François GUILHOT, MD | 33 5 49 44 42 01 | f.guilhot@chu-poitiers.fr |
France | |
University Hospital | Recruiting |
Poitiers, France, 86021 | |
Contact: François GUILHOT, MD 33 5 49 44 42 01 f.guilhot@chu-poitiers.fr | |
Principal Investigator: François GUILHOT, MD |
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) |
Study ID Numbers: | 020947, CSTI571AFR05 |
Study First Received: | September 13, 2005 |
Last Updated: | September 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00219726 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
CML Imatinib mesylate Stem cell transplantation |
Imatinib Leukemia Chronic myelogenous leukemia Hematologic Diseases |
Myeloproliferative Disorders Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Bone Marrow Diseases |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |