Nivolumab and Combination Chemotherapy in Treating Participants With Diffuse Large B-Cell Lymphoma (NCT03704714) | Clinical Trial Compass
SuspendedPhase 1/2
Nivolumab and Combination Chemotherapy in Treating Participants With Diffuse Large B-Cell Lymphoma
Stopped: Protocol being amended for stats/accrual changes as per PI
United States30 participantsStarted 2018-11-20
Plain-language summary
This phase I/II trial studies the side effects and best dose of nivolumab and how well it works when giving together with combination chemotherapy in treating participants with diffuse large B-cell lymphoma. Monoclonal antibodies, such as nivolumab, interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, 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 and combination chemotherapy may work better in treating participants with diffuse large B-cell lymphoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient must have a confirmed diagnosis of:
* De novo DLBCL including the clinical subtypes of primary mediastinal, - cell/histiocyte-rich large B-cell lymphoma and intravascular DLBCL OR
* De novo transformed DLBCL from follicular lymphoma (FL) OR
* Any high grade CD20+ B-cell lymphoma per World Health Organization (WHO) 2016 OR
* CD20+ aggressive B-cell lymphoma unclassifiable.
* Patient must be deemed an appropriate candidate for R-CHOP therapy.
* Patients must be naive to prior therapy for the study diagnosis.
* Patient must have advanced stage III/IV early stage disease where provider determines single modality therapy with chemo-immunotherapy is most appropriate (i.e radiation deferred).
* Patient must have measurable disease (defined as \>= 1.5 cm in diameter) with correlated fludeoxyglucose F-18 (FDG)-avidity on positron emission tomography (PET) scan with Deauville score of 4 or 5 at time of diagnosis.
* Patient must have Eastern Cooperative Oncology Group (ECOG) performance status =\< 2.
* Absolute neutrophil count (ANC) \>= 1000/mm\^3, independent of growth factor support or \>= 500/mm\^3 in cases of ongoing bone marrow involvement (in either case, these must be independent of transfusion support) documented =\< 28 days prior to registration.
* Platelets \>= 100,000/mm\^3, or \>= 50,000 in cases of ongoing bone marrow involvement (In either case, these must be independent of transfusion support) documented =\< 28 days prior to regist…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose (MTD) for the combination treatment of nivolumab and R-CHOP