OncRef

Clinical Trial: NCT02879695

Blinatumomab and Nivolumab With or Without Ipilimumab in Treating Patients With Poor-Risk Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-08-20

Study Overview

Brief Summary

This phase I trial studies the side effects and best dose of blinatumomab when given with nivolumab alone or nivolumab and ipilimumab in treating patients with poor-risk CD19+ precursor B-lymphoblastic leukemia that has come back after a period of improvement (relapsed) or has not responded to treatment (refractory). Immunotherapy with monoclonal antibodies, such as blinatumomab, nivolumab, and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Official Title

A Phase 1 Study of Blinatumomab in Combination With Checkpoint Inhibitor(s) of PD-1 (Nivolumab) or Both PD-1 (Nivolumab) and CTLA-4 (Ipilimumab) in Patients With Poor-Risk, Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia

Conditions

Recurrent B Acute Lymphoblastic Leukemia, Recurrent Mixed Phenotype Acute Leukemia, Refractory B Acute Lymphoblastic Leukemia, Refractory Mixed Phenotype Acute Leukemia

Intervention / Treatment

  • Procedure: Biospecimen Collection
  • Biological: Blinatumomab
  • Procedure: Bone Marrow Aspiration and Biopsy
  • Biological: Ipilimumab
  • Biological: Nivolumab

Other Study ID Numbers

  • NCI-2016-01300
  • NCI-2016-01300
  • ETCTN10030
  • 10030
  • 10030
  • UM1CA186691

Start Date (Actual)

2017-10-25

Primary Completion Date (Actual)

2023-05-22

Study Completion Date (Estimated)

2027-07-18

Enrollment (Actual)

28

Study Type

Interventional

Phase

Phase 1