Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia
2상
진행 중(모집 완료)
NCT02143414
| 대상 질환 | Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia With t; BCR-ABL1, Recurrent Acute Lymphoblastic Leukemia |
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| 임상 단계 | 2상 |
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| 스폰서 | National Cancer Institute (NCI) |
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| 상태 | 진행 중(모집 완료) |
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| 참여자 수 | 53 명 |
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| 중재(약물) | Biopsy Procedure, Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration and Biopsy, Computed Tomography |
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| 시작일 | 2015년 6월 30일 |
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| 완료일 | 2022년 6월 1일 |
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| 결과 공개일 | 2023년 1월 25일 |
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요약
This phase II trial studies the side effects and how well blinatumomab and combination chemotherapy or dasatinib, prednisone, and blinatumomab work in treating older patients with acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as prednisone, vincristine sulfate, methotrexate, and mercaptopurine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab with combination chemotherapy or dasatinib and prednisone may kill more cancer cells.
Overall Survival Rate (Cohort I)
From the day of registration on study until death from any cause, assessed at 3 years · percentage of participants
| Cohort I (Ph-) | 34 percentage of participants |
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Incidence of Dose-limiting Toxicity (Cohort II)
Up to day 42 of post-remission therapy · Participants
| Cohort II (Ph+/Ph-like) | 0 Participants |
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