CompletedPhase 2

Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

United States, Australia46 participantsStarted 2020-08-20

Plain-language summary

This was a Phase 2 trial evaluating the effectiveness and safety of tislelizumab in participants with relapsed or hard-to-treat classical Hodgkin lymphoma (cHL). Participants were grouped by prior treatments. The main outcome was to assess overall response rate (ORR) across both cohorts. Participants continued receiving the study treatment until their disease got worse, side effects became too severe, or they chose to stop for other reasons.

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

. Participants had a histologically confirmed diagnosis of relapsed or refractory classical Hodgkin lymphoma (cHL).
. Participants had either:
. Had failed to achieve a response or had experienced disease progression following autologous HSCT (a transplant using the participant's own stem cells).
. Were not considered candidates for additional autologous or allogeneic HSCT (a transplant using donor stem cells).
. Were not considered candidates for autologous or allogeneic HSCT.
. Had received at least one prior systemic therapy regimen for cHL.
. Participants had measurable disease, defined as at least one positron emission tomography (PET)-positive, 2-\\\[18F\] fluoro-2-deoxy-D-glucose (FDG)-avid nodal lesion greater than 1.5 centimeters (cm) in longest diameter, or at least one FDG-avid extranodal lesion (hepatic nodule) greater than 1.0 cm in longest diameter.

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

Overall Response Rate (ORR)

Timeframe: From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.

Trial details

NCT IDNCT04318080

SponsorBeiGene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-12

Results submitted2025-08-25

View on ClinicalTrials.gov More Classical Hodgkin Lymphoma trials

Plain-language summary

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

. Participants had a histologically confirmed diagnosis of relapsed or refractory classical Hodgkin lymphoma (cHL).
. Participants had either:
. Had failed to achieve a response or had experienced disease progression following autologous HSCT (a transplant using the participant's own stem cells).
. Were not considered candidates for additional autologous or allogeneic HSCT (a transplant using donor stem cells).
. Were not considered candidates for autologous or allogeneic HSCT.
. Had received at least one prior systemic therapy regimen for cHL.
. Participants had measurable disease, defined as at least one positron emission tomography (PET)-positive, 2-\\\[18F\] fluoro-2-deoxy-D-glucose (FDG)-avid nodal lesion greater than 1.5 centimeters (cm) in longest diameter, or at least one FDG-avid extranodal lesion (hepatic nodule) greater than 1.0 cm in longest diameter.

Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria