Trial · NCT04318080
Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma
NCT04318080, Phase 2, Completed, BeiGene; results first posted 2025-09-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma. Trials, record NCT04318080. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04318080
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma
- NCT number
- NCT04318080
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- BeiGene
- Conditions
- Classical Hodgkin Lymphoma
- Interventions
- Tislelizumab
- First posted
- 2020-03-23
- Last updated
- 2025-09-24
- Other registries' IDs
- eudract:2019-002105-22
- Results first posted
- 2025-09-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | 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. | ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) by Positron Emission Tomography (PET) and Computed Tomography (CT) per the Lugano Classification and as determined by the investigator. CR was defined as the complete disappearance of all target lesions on PET-CT, with no new lesions detected. PR was defined as a significant reduction in metabolic activity or lesion size consistent with partial tumor shrinkage as per Lugano criteria. |
| Secondary | Complete Response Rate (CRR) | 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. | CRR was defined as the percentage of participants who achieved a best overall response of complete response (CR) by PET-CT or CT per the Lugano Classification and determined by the investigator. CR was defined as the complete disappearance of all target lesions on PET-CT or CT, with no new lesions detected. |
| Secondary | Duration of Response (DOR) | 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. | DOR was defined as the time from the date that response criteria (CR or PR) were first met to the date of objectively documented disease progression or death, whichever occurred first. Participants without an event were censored at the data cutoff or end of study, whichever occurred first. Participants who received new anti-lymphoma therapies, including Hematopoietic Stem Cell Transplantation (HSCT), before having an event were censored at the date of therapy initiation. Only participants with confirmed response were included in the analysis. Median DOR was estimated using the Kaplan-Meier method. |
| Secondary | Time to Response (TTR) | 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. | TRR was defined as the time from the date of the first dose of tislelizumab to the date the response criteria were first met CR or PR per the Lugano Classification, and was analyzed only in participants who achieved an overall response; CR was defined as complete disappearance of disease, PR as ≥50% reduction in tumor burden, and Overall Response Rate (ORR) included participants with either CR or PR. |
| Secondary | Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the date of the first dose of tislelizumab through 90 days after the last dose (maximum duration of tislelizumab exposure was 168 weeks) | Adverse events (AEs) were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Treatment-emergent adverse events (TEAEs) were defined as any AE that began or worsened in severity after the first dose of study treatment and up to 90 days following the last dose, regardless of initiation of new anti-lymphoma therapy. The following safety data are reported: Number of participants with any TEAEs: Participants who experienced at least one TEAE of any grade. Number of participants with any Grade ≥3 TEAEs: Participants who experienced at least one TEAE that was Grade 3 or higher in severity. Number of participants with any SAEs: Participants who experienced at least one serious adverse event, regardless of relationship to study treatment, occurring up to 90 days after the last dose. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | 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. | Safety Analysis Set | Percentage of Participants | NUMBER |
| SECONDARY | Complete Response Rate (CRR) | 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. | Safety Analysis Set | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | 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. | The responder analysis set only included participants with a confirmed response (CR) or partial response (PR). | months | MEDIAN |
| SECONDARY | Time to Response (TTR) | 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. | Safety Analysis Set. Only participants who had achieved an overall response were included in the analysis of time to response. | months | MEDIAN |
| SECONDARY | Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the date of the first dose of tislelizumab through 90 days after the last dose (maximum duration of tislelizumab exposure was 168 weeks) | Safety Analysis set | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Cohort 1 | 64.3 | 95% Confidence Interval 35.1 to 87.2 | Percentage of Participants | |
| Overall Response Rate (ORR) | Cohort 2 | 64.5 | 95% Confidence Interval 45.4 to 80.8 | Percentage of Participants | |
| Overall Response Rate (ORR) | Total | 64.4 | 95% Confidence Interval 48.8 to 78.1 | Percentage of Participants | |
| Complete Response Rate (CRR) | Cohort 1 | 42.9 | 95% Confidence Interval 17.7 to 71.1 | Percentage of Participants | |
| Complete Response Rate (CRR) | Cohort 2 | 25.8 | 95% Confidence Interval 11.9 to 44.6 | Percentage of Participants | |
| Complete Response Rate (CRR) | Total | 31.1 | 95% Confidence Interval 18.2 to 46.6 | Percentage of Participants | |
| Duration of Response (DOR) | Cohort 1 | 12.25 | 95% Confidence Interval 5.55 to 12.25 | months | |
| Duration of Response (DOR) | Cohort 2 | 6.64 | 95% Confidence Interval 2.79 to NA | months | |
| Duration of Response (DOR) | Total | 12.25 | 95% Confidence Interval 3.02 to NA | months | |
| Time to Response (TTR) | Cohort 1 | 2.69 | Full Range 2.1 to 5.5 | months |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 15 | |
| Overall Study | STARTED | Cohort 2 | 31 | |
| Overall Study | Treated | Cohort 1 | 14 | |
| Overall Study | Treated | Cohort 2 | 31 | |
| Overall Study | COMPLETED | Cohort 1 | 0 | |
| Overall Study | COMPLETED | Cohort 2 | 0 | |
| Overall Study | NOT COMPLETED | Cohort 1 | 15 | |
| Overall Study | NOT COMPLETED | Cohort 2 | 31 |
Source ClinicalTrials.gov
Adverse events308
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1 | 1 | 14 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2 | 4 | 31 | 4 |
| other | Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | Cohort 1 | 0 | 14 | 0 |
| other | Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | Cohort 2 | 1 | 31 | 1 |
| other | Eosinophilia | Blood and lymphatic system disorders | Cohort 1 | 1 | 14 | 1 |
| other | Eosinophilia | Blood and lymphatic system disorders | Cohort 2 | 0 | 31 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 1 | 0 | 14 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 2 | 1 | 31 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Cohort 1 | 0 | 14 | 0 |
| other | Sinus tachycardia | Cardiac disorders | Cohort 2 | 1 | 31 | 1 |
1 to 10 of 308Source ClinicalTrials.gov
See all 308 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 3 | 14 |
| Total, all-cause mortality | Cohort 2 | 9 | 31 |
| Total, other adverse events | Cohort 1 | 12 | 14 |
| Total, other adverse events | Cohort 2 | 30 | 31 |
| Total, serious adverse events | Cohort 1 | 4 | 14 |
| Total, serious adverse events | Cohort 2 | 9 | 31 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1 vs Cohort 2: deaths from any cause | Trial comparisons |
| Cohort 1 vs Cohort 2: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04318080
GET https://conductscience.org/api/trials/v1/NCT04318080/events?page=2