BENITIONSClinical Trial Intelligence

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

Phase 3 Active, not recruiting NCT02003222

ConditionAcute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
PhasePhase 3
SponsorNational Cancer Institute (NCI)
StatusActive, not recruiting
Enrollment488 participants
InterventionsAllogeneic Hematopoietic Stem Cell Transplantation, Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration, Bone Marrow Biopsy
Start dateMay 19, 2014
Completion dateJun 23, 2023
Results postedSep 24, 2024

Summary

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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