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Study identifier: NCT04546399 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Down Syndrome · Recurrent B Acute Lymphoblastic Leukemia  ·  Sponsor: National Cancer Institute (NCI)

PhasePhase 2
Planned participants461
Who can joinAll sexes, 1 Year to 30 Years
Healthy volunteersNo

About this study

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. Giving nivolumab in combination with blinatumomab may cause the cancer to stop growing for a period of time, and for some patients, it may lessen the symptoms, such as pain, that are caused by the cancer.

This description comes directly from the study's public registry record.

Talk to the study team

Contact details are listed per location below or on the registry record.

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Locations (225)

Children's Hospital of AlabamaBirmingham, Alabama, United StatesRecruiting
USA Health Strada Patient Care CenterMobile, Alabama, United StatesRecruiting
Providence Alaska Medical CenterAnchorage, Alaska, United StatesSuspended
Kingman Regional Medical CenterKingman, Arizona, United StatesSuspended
Banner Children's at DesertMesa, Arizona, United StatesRecruiting
Phoenix Childrens HospitalPhoenix, Arizona, United StatesRecruiting
Banner University Medical Center - TucsonTucson, Arizona, United StatesRecruiting
Arkansas Children's HospitalLittle Rock, Arkansas, United StatesRecruiting
Kaiser Permanente-AnaheimAnaheim, California, United StatesRecruiting
PCR OncologyArroyo Grande, California, United StatesSuspended
Kaiser Permanente-BellflowerBellflower, California, United StatesSuspended
Kaiser Permanente Downey Medical CenterDowney, California, United StatesRecruiting

+ 213 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04546399