Nivolumab + Chemotherapy for Non-Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen byDavid A Bond, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: David Bond, MD

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase II trial studies how well nivolumab works with the DA-REPOCH chemotherapy regimen in treating patients with aggressive B-cell non-Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body?s immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as dose-adjusted rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (DA-REPOCH), work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab with DA-REPOCH may work better in treating patients with aggressive B-cell non-Hodgkin lymphoma.

Eligibility Criteria

This trial is for adults with aggressive B-cell non-Hodgkin lymphoma who can consent to the study, have measurable or PET avid disease, are in fair health (ECOG 0-2), and have normal organ function. Women of childbearing potential must test negative for pregnancy and use birth control; men must also agree to contraception. Exclusions include known drug hypersensitivity, prior chemotherapy (except certain cases), active CNS lymphoma, major surgery within 3 weeks before treatment, other malignancies affecting compliance or results interpretation.

Inclusion Criteria

Creatinine clearance should be calculated per institutional standard

My kidney function, measured by creatinine or GFR, is within the required range.

Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 X ULN (within 16 days of treatment initiation)

+13 more

Exclusion Criteria

I have hepatitis C with cirrhosis.

Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment

I am a man and will use effective birth control during and 3 months after the study.

+18 more

Participant Groups

The trial tests how well nivolumab works alongside DA-REPOCH chemotherapy (rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, doxorubicin hydrochloride) in treating aggressive B-cell non-Hodgkin lymphoma. Nivolumab is an immunotherapy that may boost the immune system's attack on cancer cells while DA-REPOCH aims to stop cancer cell growth.

1Treatment groups

Experimental Treatment

Group I: Treatment (nivolumab, DA-REPOCH)Experimental Treatment7 Interventions

Patients receive rituximab IV and nivolumab IV over 60 minutes on day 1. Patients also receive etoposide, vincristine sulfate and doxorubicin hydrochloride IV continuously over 96 hours, cyclophosphamide IV bolus, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After course 6, patients receive nivolumab IV over 60 minutes on day 1 every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.