Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia
第2相
実施中(募集終了)
NCT02143414
| 対象疾患 | Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia With t; BCR-ABL1, Recurrent Acute Lymphoblastic Leukemia |
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| 相 | 第2相 |
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| スポンサー | National Cancer Institute (NCI) |
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| ステータス | 実施中(募集終了) |
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| 参加者数 | 53 名 |
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| 介入(薬剤) | Biopsy Procedure, Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration and Biopsy, Computed Tomography |
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| 開始日 | 2015年6月30日 |
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| 完了日 | 2022年6月1日 |
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| 結果公開日 | 2023年1月25日 |
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概要
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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