Blinatumomab + Nivolumab (+/- Ipilimumab) for Acute Lymphoblastic Leukemia

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen byIvana Gojo

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ivana Gojo

Principal Investigator

JHU Sidney Kimmel Comprehensive Cancer Center LAO

Eligibility Criteria

This trial is for patients aged 16 or older with poor-risk CD19+ precursor B-lymphoblastic leukemia that's relapsed or refractory. It includes those over 60 who can't have standard treatment, and excludes pregnant women, breastfeeding mothers, and individuals with certain health conditions like uncontrolled illnesses or active CNS leukemia.

Inclusion Criteria

Adequate contraception agreement for women of child-bearing potential and men

Specific laboratory criteria including total bilirubin, AST/ALT, and serum creatinine or CrCl

My leukemia is Philadelphia chromosome positive.

See 9 more

Exclusion Criteria

I have lung disease that causes me symptoms.

I have a condition affecting my digestive system.

I have a diagnosed brain condition.

See 13 more

Treatment Details

Interventions

Blinatumomab (Monoclonal Antibodies)
Ipilimumab (Checkpoint Inhibitor)
Nivolumab (Checkpoint Inhibitor)

Trial OverviewThe study tests the safety and optimal doses of blinatumomab combined with nivolumab alone or alongside ipilimumab in treating specific leukemia. These are immunotherapies designed to help the immune system fight cancer by targeting tumor cells' growth.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (blinatumomab, nivolumab, ipilimumab)Experimental Treatment5 Interventions

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.