Acute Lymphoblastic Leukemia Treatment with Blinatumomab in Combination with Nivolumab – Phase II

AALL1821: A Study to Compare Blinatumomab Alone to Blinatumomab with Nivolumab in Patients Diagnosed with First Relapse B-cell Acute Lymphoblastic Leukemia

Protocol Description

The goal of this multi-center Children’s Oncology Group study is to study the effects of the combination of blinatumomab and nivolumab on people who have experienced their first relapse of B-cell acute lymphoblastic leukemia (B-ALL) following prior treatment, as compared to treatment using blinatumomab without nivolumab.

Study Level: II

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling patients ages 1 through 30 years, who have been diagnosed with first bone marrow relapse of B-ALL. For participants under age 18, relapse must have occurred less than 24 months after initial diagnosis.
Males and Females: Ages 1 through 30 years


Participants will be randomly selected to receive, via intravenous infusion, either the medicine blinatumomab alone or with nivolumab as part of a 5-week immunotherapy cycle. Participants may receive up to 2 cycles of immunotherapy. Initial days of each cycle require hospitalization for observation and testing, and return visits are required throughout the cycle period. It is recommended that participants proceed to hematopoietic stem cell transplant upon completion of immunotherapy.
Visits: The number of visits varies based on participant response to therapy.
Duration: About 2-1/2 months for treatment in most cases, and 5 years for long term follow-up.

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (AALL1821)
National Cancer Institute

Primary Investigator

A. Kim Ritchey, MD

Contact Information

For more information about the study or enrollment, please contact the UPMC Children’s Hospital of Pittsburgh Hematology-Oncology research team, at: