A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Summary

This phase II trial studies the effect of nivolumab in combination with blinatumomab compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in this study. Blinatumomab is an antibody, which is a protein that identifies and targets specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a medicine that may boost a patient's immune system.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Down Syndrome
• Recurrent B Acute Lymphoblastic Leukemia

Eligibility basics and study details

Study type

Interventional

Phase

Phase 2

Ages

1 year to 30 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

National Cancer Institute (NCI)

Last updated on ClinicalTrials.gov

September 1, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

+2 more sites listed on ClinicalTrials.gov