Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia
第3相
実施中(募集終了)
NCT02101853
| 対象疾患 | Recurrent B Acute Lymphoblastic Leukemia |
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| 相 | 第3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 | 669 名 |
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| 介入(薬剤) | Allogeneic Hematopoietic Stem Cell Transplantation, Asparaginase, Blinatumomab, Cyclophosphamide, Cytarabine |
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| 開始日 | 2014年12月17日 |
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| 完了日 | 2021年6月30日 |
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| 結果公開日 | 2022年12月6日 |
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概要
This randomized phase III trial studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Immunotherapy with blinatumomab may allow the body's immune system to attack and destroy some types of leukemia cells. It is not yet known whether blinatumomab is more effective than standard combination chemotherapy in treating relapsed B-cell acute lymphoblastic leukemia.
Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients
Up to 2 years from date of randomization · percentage of participants
| Arm A (HR and IR Control) | 39.04 percentage of participants |
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| Arm B (HR and IR Blinatumomab) | 54.44 percentage of participants |
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Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients
Up to 3 years from date of randomization · percentage of participants
| Arm C (LR Control) | 58.94 percentage of participants |
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| Arm D (LR Blinatumomab) | 67.00 percentage of participants |
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