Trial · NCT03209973
A Study of Tislelizumab as Monotherapy in Relapsed or Refractory Classical Hodgkin Lymphoma
NCT03209973, Phase 2, Completed, BeiGene; results first posted 2020-10-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tislelizumab as Monotherapy in Relapsed or Refractory Classical Hodgkin Lymphoma. Trials, record NCT03209973. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03209973
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tislelizumab as Monotherapy in Relapsed or Refractory Classical Hodgkin Lymphoma
- NCT number
- NCT03209973
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- BeiGene
- Conditions
- Classical Hodgkin Lymphoma
- Interventions
- Tislelizumab
- First posted
- 2017-07-06
- Last updated
- 2025-02-05
- Results first posted
- 2020-10-12
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | From the date of first dose Up to approximately 3 year and 7 months | ORR is defined as the proportion of participants who achieve a best response of Complete Response (CR) or Partial Response (PR), as assessed by Independent Review committee (IRC) per the Lugano Classification |
| Secondary | Progression-free Survival (PFS) | From the date of first dose until end of study (Up to approximately 3 years and 7 months) | PFS is defined as the time from the first dose of tislelizumab to the date of Progressive Disease (PD) or death, whichever occurs first, assessed by IRC per the Lugano Classification |
| Secondary | Duration of Response (DOR) | From the date of first dose until end of study (Up to approximately 3 years and 7 months) | DOR is defined as the time from the date that response criteria are first met to the date that PD is objectively documented or death, whichever occurs first, assessed by IRC per the Lugano Classification |
| Secondary | Rate of Complete Response (CRR) | From the date of first dose until end of study (Up to approximately 3 years and 7 months) | CRR is defined as the percentage of participants who achieve a best response of CR, assessed by IRC per the Lugano Classification |
| Secondary | Time to Response (TTR) | From the date of first dose until end of study (Up to approximately 3 years and 7 months) | TTR is defined as the time from the date of the first dose of tislelizumab to the time the response criteria are first met, assessed by IRC per the Lugano Classification |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the date of first dose until end of study (Up to approximately 3 years and 7 months) | An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not. An SAE is any untoward medical occurrence that, at any dose: * Results in death. * Is life-threatening. * Requires hospitalization or prolongation of existing hospitalization * Results in disability/incapacity * Is a congenital anomaly/birth defect * Is considered a significant medical AE by the investigator based on medical judgement |
| Secondary | Number of Participants With Significant Changes in Clinical Laboratory Results | From the date of first dose until end of study (Up to approximately 3 years and 7 months) | Clinical laboratory (e.g. hematology, serum chemistry, urinalysis) values were evaluated for each laboratory parameter and participants with clinically significant changes are summarized. |
| Secondary | Number of Participants With Significant Changes in Electrocardiograms | From the date of first dose until end of study (Up to approximately 3 years and 7 months) |
Source ClinicalTrials.gov
Outcomes8
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 the date of first dose Up to approximately 3 year and 7 months | Modified Safety Analysis Set: All participants in the safety analysis set who had confirmed classical Hodgkin lymphoma. | Percentage of Participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | From the date of first dose until end of study (Up to approximately 3 years and 7 months) | Modified Safety Analysis set | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | From the date of first dose until end of study (Up to approximately 3 years and 7 months) | Modified Safety Analysis set; Participants with available data were included in the analysis. | Months | MEDIAN |
| SECONDARY | Rate of Complete Response (CRR) | From the date of first dose until end of study (Up to approximately 3 years and 7 months) | Modified safety analysis set | Percentage of participants | MEDIAN |
| SECONDARY | Time to Response (TTR) | From the date of first dose until end of study (Up to approximately 3 years and 7 months) | Modified safety analysis set; participants with available data were included in the analysis. | Weeks | MEDIAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the date of first dose until end of study (Up to approximately 3 years and 7 months) | The Safety Analysis Set included all participants who received any dose of tislelizumab. | Participants | NUMBER |
| SECONDARY | Number of Participants With Significant Changes in Clinical Laboratory Results | From the date of first dose until end of study (Up to approximately 3 years and 7 months) | The Safety Analysis Set included all participants who received any dose of tislelizumab. | Participants | NUMBER |
| SECONDARY | Number of Participants With Significant Changes in Electrocardiograms | From the date of first dose until end of study (Up to approximately 3 years and 7 months) | The Safety Analysis Set included all participants who received any dose of tislelizumab. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
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) | Tislelizumab | 87.1 | 95% Confidence Interval 77.0 to 93.9 | Percentage of Participants | |
| Progression-free Survival (PFS) | Tislelizumab | 31.5 | 95% Confidence Interval 16.53 to NA | Months | |
| Duration of Response (DOR) | Tislelizumab | 31.3 | 95% Confidence Interval 20.73 to NA | Months | |
| Rate of Complete Response (CRR) | Tislelizumab | 67.1 | 95% Confidence Interval 54.9 to 77.9 | Percentage of participants | |
| Time to Response (TTR) | Tislelizumab | 12.0 | Full Range 11.86 to 12.29 | Weeks | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Tislelizumab | Participants with At least one TEAE | 68 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Tislelizumab | SAE | 18 | Participants | |
| Number of Participants With Significant Changes in Clinical Laboratory Results | Tislelizumab | 0 | Participants | ||
| Number of Participants With Significant Changes in Electrocardiograms | Tislelizumab | Postbaseline corrected QT interval > 450 msec | 0 | Participants | |
| Number of Participants With Significant Changes in Electrocardiograms | Tislelizumab | ≥ 1 postbaseline electrocardiogram | 21 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tislelizumab | 70 | |
| Overall Study | Completed Primary Outcome Period | Tislelizumab | 66 | |
| Overall Study | COMPLETED | Tislelizumab | 0 | |
| Overall Study | NOT COMPLETED | Tislelizumab | 70 |
Source ClinicalTrials.gov
Adverse events79
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 | Tislelizumab | 9 | 70 | 18 |
| other | Leukopenia | Blood and lymphatic system disorders | Tislelizumab | 6 | 70 | 10 |
| other | Lymphopenia | Blood and lymphatic system disorders | Tislelizumab | 3 | 70 | 33 |
| other | Neutropenia | Blood and lymphatic system disorders | Tislelizumab | 4 | 70 | 6 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Tislelizumab | 4 | 70 | 9 |
| other | Hyperthyroidism | Endocrine disorders | Tislelizumab | 3 | 70 | 4 |
| other | Hypothyroidism | Endocrine disorders | Tislelizumab | 26 | 70 | 64 |
| other | Diarrhoea | Gastrointestinal disorders | Tislelizumab | 10 | 70 | 13 |
| other | Nausea | Gastrointestinal disorders | Tislelizumab | 6 | 70 | 7 |
| other | Toothache | Gastrointestinal disorders | Tislelizumab | 3 | 70 | 3 |
1 to 10 of 79Source ClinicalTrials.gov
See all 79 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tislelizumab | 8 | 70 |
| Total, other adverse events | Tislelizumab | 68 | 70 |
| Total, serious adverse events | Tislelizumab | 18 | 70 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03209973
GET https://conductscience.org/api/trials/v1/NCT03209973/events?page=2