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Sponsored by: |
Bristol-Myers Squibb |
---|---|
Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00454753 |
This protocol allows CML and Ph+ ALL subjects who are resistant to or intolerant of imatinib mesylate, to potentially benefit from dasatinib. It is intended to provide patients with access to dasatinib while awaiting reimbursement decision in Korea and it will also provide additional data on the safety of dasatinib in Korean population
Condition | Intervention |
---|---|
Leukemia |
Drug: Dasatinib |
Study Type: | Expanded Access |
Official Title: | Study of Dasatinib (BMS-354825) in Subjects With Chronic Phase or Advanced Chronic Myelogenous Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Who Are Resistant to or Intolerant of Imatinib Mesylate |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Korea, Republic of | |
Local Institution | |
Seoul, Korea, Republic of, 150-713 | |
Local Institution | |
Seoul, Korea, Republic of, 110-744 | |
Local Institution | |
Seoul, Korea, Republic of, 138-736 | |
Local Institution | |
Jellanamdo, Korea, Republic of, 519-809 | |
Local Institution | |
Daejeon, Korea, Republic of, 301-721 | |
Local Institution | |
Daegu, Korea, Republic of, 701-600 | |
Local Institution | |
Daegu, Korea, Republic of, 700-721 | |
Local Institution | |
Seoul, Korea, Republic of, 134-701 | |
Local Institution | |
Seoul, Korea, Republic of, 135-710 | |
Local Institution | |
Seoul, Korea, Republic of, 158-710 | |
Local Institution | |
Busan, Korea, Republic of, 602-739 | |
Local Institution | |
Seoul, Korea, Republic of, 120-752 | |
Local Institution | |
Seoul, Korea, Republic of, 134-060 | |
Local Institution | |
Gyeonggi-do, Korea, Republic of, 431-070 | |
Local Institution | |
Seoul, Korea, Republic of, 136-705 | |
Local Institution | |
Busan, Korea, Republic of, 602-702 | |
Local Institution | |
Jeollabuk-do, Korea, Republic of, 561-712 | |
Local Institution | |
Seoul, Korea, Republic of, 137-701 | |
Local Institution | |
Incheon, Korea, Republic of, 400-711 | |
Local Institution | |
Daegu, Korea, Republic of, 705-030 | |
Local Institution | |
Ulsan, Korea, Republic of, 682-061 | |
Local Institution | |
Daegu, Korea, Republic of, 700-310 | |
Local Institution | |
Daegu, Korea, Republic of, 705-825 | |
Local Institution | |
Seoul, Korea, Republic of, 130-050 | |
Local Institution | |
Busan, Korea, Republic of, 602-739 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb, Korea |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CA180-109 |
Study First Received: | March 30, 2007 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00454753 |
Health Authority: | Korea: Food and Drug Administration |
Myeloid, Chronic Lymphocytic, Acute |
Philadelphia Chromosome Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Chronic myelogenous leukemia Hematologic Diseases Myeloproliferative Disorders Leukemia, Myeloid |
Imatinib Leukemia Lymphatic Diseases Dasatinib Leukemia, Myelogenous, Chronic, BCR-ABL Positive Lymphoproliferative Disorders Bone Marrow Diseases Lymphoma |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases |
Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |