About this trial
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.
Eligibility criteria
Qualifiers
Patients must be >= 1 and < 31 years at time of enrollment
Isolated bone marrow relapse
Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse
Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes
Disqualifiers
Patients with B-lymphoblastic lymphoma (B-LLy)
Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia
Patients with Philadelphia chromosome positive (Ph+) B-ALL or ABL class Ph-like B-ALL (i.e. rearrangements involving ABL1, ABL2, CSF1R or PDGFRB and predicted to be sensitive to imatinib or dasatinib)
Patients with mixed phenotype acute leukemia (MPAL)
Trial design
Treatments tested in this trial
- 3-Dimensional Conformal Radiation Therapy
- Asparaginase Erwinia chrysanthemi
- Biospecimen Collection
- Blinatumomab
- Bone Marrow Aspiration
- Bone Marrow Biopsy
- Calaspargase Pegol
- Cytarabine
- Dexamethasone
- Hydrocortisone Sodium Succinate
- Lumbar Puncture
- Mercaptopurine
- Methotrexate
- Nivolumab
- Pegaspargase
- Vincristine Sulfate
Treatment groups
9
Treatment groupsSee each treatment group below.