Study of Pembrolizumab With Bendamustine in Hodgkin Lymphoma (NCT04510636) | Clinical Trial Compass
RecruitingPhase 2
Study of Pembrolizumab With Bendamustine in Hodgkin Lymphoma
Canada40 participantsStarted 2021-12-20
Plain-language summary
This is a phase 2 open-label study to test the safety and effectiveness of combining pembrolizumab and bendamustine in patients with relapsed (cancer that has come back or started getting worse) or refractory (cancer that is not responding or has stopped responding to treatment) Hodgkin 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:
* Be willing and able to provide written informed consent for the trial and adhere to trial procedures.
* Be age ≥18 years at the time of signing informed consent.
* Have histologically confirmed relapsed (disease progression after most recent therapy) or refractory (failure to achieve CR or PR to most recent therapy) classical Hodgkin Lymphoma (RR HL).
* Must have received at least standard first line chemotherapy for classical Hodgkin Lymphoma, containing an anthracycline, i.e. ABVD or BEACOPP.
* Must have failed or declined autologous stem cell transplantation (ASCT), or not be a candidate for ASCT (as per institutional criteria).
* May have received prior therapy with pembrolizumab (or an equivalent checkpoint inhibitor or anti-PD-L1 antibody), but not in combination with bendamustine.
* May have received a prior autologous stem cell transplant but must be at least ≥100 days post-auto-transplant, and all transplant- related adverse events must have resolved to a grade 1 or less, and patients are not on immunosuppression, and meet all other eligibility criteria.
* Must have measurable or evaluable disease, as defined as at least one lesion that can be accurately measured in at least 2 dimensions by CT/PET scan. The minimum measurement must be \>15 mm in the longest dimension or \>10 mm in the short axis. Baseline FDG-PET scan must be positive (i.e. FDG-avid HL). Measurements must be done within 28 days prior to trial inclusion..
* Must have Eastern Coo…
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
Overall response rate
Timeframe: 5 years
2
Complete response rate as determined by Lugano criteria