Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia

3期进行中（已停止招募） NCT02003222

适应症	Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
分期	3期
申办方	National Cancer Institute (NCI)
状态	进行中（已停止招募）
受试者人数	488 人
干预（药物）	Allogeneic Hematopoietic Stem Cell Transplantation, Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration, Bone Marrow Biopsy
开始日期	2014年5月19日
完成日期	2023年6月23日
结果公布日	2024年9月24日

摘要

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
MRD Negative - Chemotherapy	NA months

p-value	0.003
Hazard Ratio (HR)	0.44 (95% CI 0.25–0.76)

在 BENITIONS 中查看查看 ClinicalTrials.gov 原文

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全部试验

本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。

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