BENITIONSClinical Trial Intelligence

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
第3相
スポンサーNational Cancer Institute (NCI)
ステータス実施中(募集終了)
参加者数488 名
介入(薬剤)Allogeneic Hematopoietic Stem Cell Transplantation, Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration, Bone Marrow Biopsy
開始日2014年5月19日
完了日2023年6月23日
結果公開日2024年9月24日

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 + ChemotherapyNA months
MRD Negative - ChemotherapyNA months
p-value0.003
Hazard Ratio (HR)0.44 (95% CI 0.25–0.76)

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