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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
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 outcome measures
Expression of PD-1 and PD-L1 with PFS
Major histocompatibility complex (MCH) class I and II expression
DNA
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
1995
Completed Phase 3
~3770
Rituximab
1999
Completed Phase 4
~1880
Vincristine Sulfate
2005
Completed Phase 3
~10110
Prednisone
2014
Completed Phase 4
~2370
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Etoposide
2010
Completed Phase 3
~2440
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
David Bond, MDLead Sponsor
3 Previous Clinical Trials
80 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,129,002 Total Patients Enrolled
David A Bond, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
37 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have hepatitis C with cirrhosis.My kidney function, measured by creatinine or GFR, is within the required range.I am a woman who can have children and my pregnancy test was negative.I am a man and will use effective birth control during and 3 months after the study.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I am willing to follow strict birth control measures or abstain from sex during and 5 months after the study.I have an autoimmune disease treated with strong medication in the last 2 years.I do not have serious heart issues like recent heart attacks or uncontrolled irregular heartbeats.I cannot swallow pills or have a condition that affects my stomach or intestines badly.I do not have any known allergies or severe side effects to the medications planned for my treatment.I have an active lymphoma in my brain or spinal cord.I have not had major surgery in the last 3 weeks.I have hepatitis B but it's under control with medication.I agree to use contraception and not donate sperm for 7 months after my last nivolumab dose.My cancer can be measured or seen on a PET scan.I am not on strong immune system suppressing drugs, except for low-dose or topical steroids.My cancer is at stage II-IV according to the Ann Arbor classification.My CLL has transformed into a more aggressive form.I have an active infection needing IV treatment or an uncontrolled infection.I was diagnosed with hepatitis C in the last 6 months.I am using effective birth control or am not of childbearing potential.My condition is early-stage primary mediastinal B-cell lymphoma or a type that's between DLBCL and Hodgkin’s.You have known allergies or bad reactions to any of the study drugs.I've had chemotherapy for lymphoma, but only used steroids or rituximab for mild cases.I have HIV with a low CD4 count or a high viral load.I can take care of myself and am up and about more than half of my waking hours.I have had another type of cancer that might interfere with this study.I have an active tuberculosis infection.My platelet count is at least 75,000 without recent transfusions.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nivolumab, DA-REPOCH)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Nivolumab has received FDA approval, correct?
"While there is some data suggesting that Nivolumab is safe, it only received a score of 2 because this is a Phase 2 trial and thus there is no efficacy data to support its use."
Answered by AI
How many people are included in the research project?
"This trial is not currently admitting patients. The listing for this clinical study was first posted on 1/2/2019 and last updated on 8/18/2022. However, there are 2415 trials for Nivolumab and 1895 studies for lymphoma that are enrolling patients at this time."
Answered by AI
Are we looking for participants in this clinical trial at the moment?
"According to the clinicaltrials.gov listing, this research is not presently looking for participants. This study was originally published on 2nd January 2019 and updated on 18th August 2020. Even though this specific trial has completed recruitment, there are 4310 other studies that are still enrolling patients."
Answered by AI
What other similar tests has Nivolumab undergone?
"As of now, 2415 Nivolumab trials are ongoing with 459 in Phase 3. The majority are based near Bethesda, Maryland; however, 98471 locations worldwide are running these sorts of tests."
Answered by AI
What are the main health conditions that Nivolumab is effective against?
"Nivolumab is a medication typically given to patients with prostate cancer, however it has also shown efficacy in the treatment of squamous cell carcinoma, pheochromocytomas, and ulcerative colitis."
Answered by AI
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