A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination With Nivolumab (NSC # 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/= 1 to < 31 Years Old With First Relapse

Summary

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.

Description

Eligibility

Age range

1–30 years

Sex

All

Healthy volunteers

No

Interventions

• Radiation
  3-Dimensional Conformal Radiation Therapy

  Undergo 3D-CRT

• Procedure
  Biospecimen Collection

  Undergo blood, urine and cerebrospinal fluid collection

• Biological
  Blinatumomab

  Given IV

• Procedure
  Bone Marrow Aspiration

  Undergo bone marrow aspiration

• Procedure
  Bone Marrow Biopsy

  Undergo bone marrow biopsy

• Drug
  Calaspargase Pegol

  Given IV

• Drug
  Cytarabine

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