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Anti-tumor antibiotic, Alkylating agents, Anti-metabolites

Nivolumab + Chemotherapy for Non-Hodgkin's Lymphoma

Phase 2

Waitlist Available

Led By David A Bond, MD

Research Sponsored by David Bond, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female subject of childbearing potential should have a negative serum pregnancy at screening

Measurable disease (defined as >= 1.5 cm in diameter) or at least one PET avid area of disease

Must not have

Positive hepatitis C antibody with evidence of cirrhosis

Clinically significant cardiovascular disease, including uncontrolled arrhythmia, New York Association class 2- 4 congestive heart failure, or history of myocardial infarction within 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying nivolumab in combination with DA-REPOCH to treat patients with aggressive B-cell non-Hodgkin lymphoma.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions related to the immune system attacking healthy organs (immunotherapy-related), infusion reactions from drugs being administered into the bloodstream directly as well as typical chemotherapy side effects like fatigue, nausea/vomiting/diarrhea (digestive issues), low blood counts leading to increased infection risk or bleeding tendencies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman who can have children and my pregnancy test was negative.

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My cancer can be measured or seen on a PET scan.

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My cancer is at stage II-IV according to the Ann Arbor classification.

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I can take care of myself and am up and about more than half of my waking hours.

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My platelet count is at least 75,000 without recent transfusions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have hepatitis C with cirrhosis.

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I do not have serious heart issues like recent heart attacks or uncontrolled irregular heartbeats.

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I have an autoimmune disease treated with strong medication in the last 2 years.

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

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I cannot swallow pills or have a condition that affects my stomach or intestines badly.

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I do not have any known allergies or severe side effects to the medications planned for my treatment.

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I have an active lymphoma in my brain or spinal cord.

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My CLL has transformed into a more aggressive form.

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I have an active infection needing IV treatment or an uncontrolled infection.

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I have HIV with a low CD4 count or a high viral load.

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I have an active tuberculosis infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS)

Secondary study objectives

Duration of response defined for all patients who have achieved an objective response (CR or PR)

Incidence of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Objective response rate

Other study objectives

Expression of PD-1 and PD-L1 with PFS

Major histocompatibility complex (MCH) class I and II expression

DNA

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Prednisone

2014

Completed Phase 4

~2500