Study Information
Summary / Purpose
This study looks at how well blinatumomab and nivolumab combined works compared to blinatumomab alone when given to children and young adults with first marrow relapse of B-ALL. Study doctors want to see if the combination of blinatumomab with nivolumab makes blinatumomab more effective.
Study Type: Interventional
Accepts Healthy Volunteers: No
Who Can Participate
Eligibility Criteria: - Children and Adults 3 - 31 years of age
- Patients must have first relapse of CD19+ B-ALL
- Must have fully recovered from the acute toxic effects of all prior therapy
- Must have adequate renal, cardiac, and lung function
What's Involved
Participation in the study will include: - Assignment to a treatment group based on when and where the leukemia came back
- Random assignment to receive either blinatumomab alone or blinatumomab plus nivolumab
- Chemotherapy, which may include vincristine, dexamethasone, methotrexate, cytarabine, mercaptopurine, and asparaginase-type drugs (pegaspargase, calaspargase pegol, or pegcrisantaspase), depending on your treatment group
- Blinatumomab, an antibody that helps your immune system find and attack leukemia cells
- Nivolumab, a medicine that boosts the immune system, for participants assigned to that group
- Bone marrow aspiration and bone marrow biopsy to check how the leukemia is responding
- Lumbar puncture, a procedure that uses a needle to collect fluid from around the spinal cord
- Radiation therapy, if needed
- Sample collection for research
Principal Investigator
Additional Information
Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.
