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Brief Title: Study of Imatinib-Combined Chemotherapy for BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL)
Official Title: Phase 2 Study of Imatinib-Combined Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia
Study ID: NCT00130195
Brief Summary: The purpose of this study is to determine the clinical efficacy and safety of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.
Detailed Description: Philadelphia chromosome (Ph) is a translocation abnormality leading to the formation of the BCR-ABL gene rearrangement. This genetic abnormality occurs in up to 30% of adult acute lymphoblastic leukemia (ALL), and its presence is known to be the most adverse prognostic factor for ALL. Because long-term survival cannot be achieved by conventional chemotherapy alone, there is a clear medical need for alternative treatment approaches. Imatinib is a potent selective inhibitor of the BCR-ABL protein kinase, and it has been reported that single-agent imatinib induced response in a substantial proportion of Ph-positive ALL (Ph+ALL) patients, but that the response was not durable. The Japan Adult Leukemia Study Group (JALSG) has therefore started a phase 2 study designed to evaluate the clinical effect of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.
Minimum Age: 15 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Department of Hematology, Nagoya University Graduate School of Medicine, Nagoya, , Japan
Name: Fumihiko Hayakawa, MD
Affiliation: Nagoya University
Role: STUDY_DIRECTOR
Name: Tomoki Naoe, MD
Affiliation: Nagoya University
Role: STUDY_CHAIR