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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-30
SponsorNational Cancer Institute (NCI)

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

461 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.