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

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.

Trial Details

NCT ID
NCT04546399
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • 3-Dimensional Conformal Radiation Therapy
  • Asparaginase Erwinia chrysanthemi
  • Biospecimen Collection
  • Blinatumomab
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Kingman, Arizona, United States|35.18944,-114.05301
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Little Rock, Arkansas, United States|34.74648,-92.28959

Key Eligibility Criteria

  • Patients must be \>= 1 and \< 31 years at time of enrollment
  • Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories:
  • Isolated bone marrow relapse
  • Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse

For full eligibility, visit ClinicalTrials.gov.

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