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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02879695
Phase
PHASE1
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Blinatumomab — BIOLOGICAL
    Given IV
  • Bone Marrow Aspiration and Biopsy — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Ipilimumab — BIOLOGICAL
    Given IV
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Oct 25, 2017
Status verified
Jan 2026
Primary completion
May 22, 2023
Completion
Jul 18, 2026

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (blinatumomab, nivolumab, ipilimumab)
    Patients receive blinatumomab IV continuously on days 1-28. Treatment repeats every 42 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes on day 11 and then every 2 weeks for up to year. Some patients also receive ipilimumab IV over 90 minutes on day 11 and then every 6 weeks for up to 1 year. Patients also undergo bone marrow aspiration and biopsy and blood sample collection throughout the study.

Primary Outcome Measure

Number of Participants Experiencing Grade 3, 4, or 5 Adverse Events [ Time Frame: Up to 5.5 years ]

Locations (7)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06520-
University of Kentucky/Markey Cancer CenterLexingtonKentucky40536-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-

Find similar trials in New Haven, CT

By research site
Yale University· New Haven, CTUniversity of Kentucky/Markey Cancer Center· Lexington, KYJohns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MDDana-Farber Cancer Institute· Boston, MAOhio State University Comprehensive Cancer Center· Columbus, OHUniversity of Pittsburgh Cancer Institute (UPCI)· Pittsburgh, PA

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