Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia
第3相
実施中(募集終了)
NCT02003222
| 対象疾患 | Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative |
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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 | 488 名 |
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| 介入(薬剤) | Allogeneic Hematopoietic Stem Cell Transplantation, Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration, Bone Marrow Biopsy |
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| 開始日 | 2014年5月19日 |
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| 完了日 | 2023年6月23日 |
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| 結果公開日 | 2024年9月24日 |
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概要
This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy 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. 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. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.
Overall Survival (OS) Among Patients Who Were MRD Negative After Induction and Intensification Chemotherapy
Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years · months
| MRD Negative - Blinatumomab + Chemotherapy | NA months |
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| MRD Negative - Chemotherapy | NA months |
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| p-value | 0.003 |
| Hazard Ratio (HR) | 0.44 (95% CI 0.25–0.76) |
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