Trial · NCT02939014
Brentuximab Vedotin in Chinese Participants With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL)
NCT02939014, Phase 2, Completed, Takeda; results first posted 2019-09-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Brentuximab Vedotin in Chinese Participants With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL). Trials, record NCT02939014. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02939014
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brentuximab Vedotin in Chinese Participants With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL)
- NCT number
- NCT02939014
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 39 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Hodgkin Disease, Lymphoma, Large-Cell, Anaplastic
- Interventions
- Brentuximab Vedotin
- First posted
- 2016-10-19
- Last updated
- 2021-02-24
- Results first posted
- 2019-09-06
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Baseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment until disease progression death or end of treatment (approximately 12 months) | ORR is defined as the percentage of participants who have achieved complete remission (CR)=disappearance of all evidence of disease or partial remission (PR)=regression of greater than or equal to 50% of measurable disease and no new site by end of treatment (EOT) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. |
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | First dose of study drug up to 30 days after last dose of study drug (approximately 12 months) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs or worsens after receiving study drug. |
| Primary | Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events | First dose of study drug up to 30 days after last dose of study drug (approximately 12 months) | Clinical Laboratory tests included tests of Chemistry, Hematology and Urinalysis prespecified in the protocol. Abnormal laboratory values assessed by the investigator that lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or were considered by the investigator to be clinically significant changes from Baseline were recorded as Adverse Events. Neutropenia (pooled) includes preferred terms Neutropenia and Neutrophil count decreased. |
| Primary | Number of Participants With Abnormal Vital Signs Reported as Adverse Events | First dose of study drug up to 30 days after last dose of study drug (approximately 12 months) | Vital signs included blood pressure in the sitting position, pulse rate, axillary temperature and weight. Abnormal vital sign values considered by the investigator to be clinically significant were recorded as Adverse Events. |
| Secondary | Complete Remission (CR) Rate | Baseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment, and every 12 weeks during PFS follow-up period, until disease progression death or end of treatment (approximately 12 months) | CR rate is defined as the percentage of participants who have achieved CR by EOT. CR is defined as disappearance of all evidence of disease per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. |
| Secondary | Duration of Response (DOR) | Up to 3.2 years | DOR is defined as the time between the first documentation of objective tumor response (CR or PR) and the first subsequent documentation of objective tumor progression or death due to any cause, whichever occurs first. CR is defined as disappearance of all evidence of disease. PR is defined as regression of greater than or equal to 50% of measurable disease and no new sites. |
| Secondary | Progression Free Survival (PFS) | Up to 3.2 years | PFS is defined as the time from the start of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. |
| Secondary | Overall Survival (OS) | Up to 3.2 years | Overall survival is defined as the time from the start of treatment to the date of death. |
| Secondary | B Symptom Resolution Rate | Day 1 of each cycle (each cycle was of 3 weeks) up to 30 days after last dose of study drug (approximately 12 months) | B Symptom Resolution Rate is defined as the percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss \>10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period. |
| Secondary | Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC) | Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
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) | Baseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment until disease progression death or end of treatment (approximately 12 months) | Modified Intent-to-Treat (mITT) Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin. | percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | First dose of study drug up to 30 days after last dose of study drug (approximately 12 months) | Safety Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events | First dose of study drug up to 30 days after last dose of study drug (approximately 12 months) | Safety Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Vital Signs Reported as Adverse Events | First dose of study drug up to 30 days after last dose of study drug (approximately 12 months) | Safety Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Complete Remission (CR) Rate | Baseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment, and every 12 weeks during PFS follow-up period, until disease progression death or end of treatment (approximately 12 months) | mITT Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Up to 3.2 years | mITT Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin. Only responders were analyzed for this outcome measure. | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | Up to 3.2 years | mITT Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to 3.2 years | mITT Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin. | months | MEDIAN |
| SECONDARY | B Symptom Resolution Rate | Day 1 of each cycle (each cycle was of 3 weeks) up to 30 days after last dose of study drug (approximately 12 months) | Participants from the mITT Population, all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin, who had lymphoma-related B symptoms at baseline. | percentage of participants | NUMBER |
| SECONDARY | Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC) | Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose | Pharmacokinetic (PK)-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist. | micrograms/milliliter (ug/mL) | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group164
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) | Brentuximab Vedotin 1.8 mg/kg (HL) | 70.0 | 95% Confidence Interval 50.60 to 85.27 | percentage of participants | |
| Overall Response Rate (ORR) | Brentuximab Vedotin 1.8 mg/kg (sALCL) | 66.7 | 95% Confidence Interval 29.93 to 92.51 | percentage of participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Brentuximab Vedotin 1.8 mg/kg (HL) | 30 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Brentuximab Vedotin 1.8 mg/kg (sALCL) | 9 | Participants | ||
| Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events | Brentuximab Vedotin 1.8 mg/kg (HL) | Alanine aminotransferase increased | 18 | Participants | |
| Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events | Brentuximab Vedotin 1.8 mg/kg (sALCL) | Alanine aminotransferase increased | 6 | Participants | |
| Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events | Brentuximab Vedotin 1.8 mg/kg (HL) | Aspartate aminotransferase increased | 17 | Participants | |
| Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events | Brentuximab Vedotin 1.8 mg/kg (sALCL) | Aspartate aminotransferase increased | 6 | Participants | |
| Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events | Brentuximab Vedotin 1.8 mg/kg (HL) | Gamma-glutamyltransferase increased | 3 | Participants | |
| Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events | Brentuximab Vedotin 1.8 mg/kg (sALCL) | Gamma-glutamyltransferase increased | 4 | Participants |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Brentuximab Vedotin 1.8 mg/kg (HL) | 30 | |
| Overall Study | STARTED | Brentuximab Vedotin 1.8 mg/kg (sALCL) | 9 | |
| Overall Study | COMPLETED | Brentuximab Vedotin 1.8 mg/kg (HL) | 25 | |
| Overall Study | COMPLETED | Brentuximab Vedotin 1.8 mg/kg (sALCL) | 6 | |
| Overall Study | NOT COMPLETED | Brentuximab Vedotin 1.8 mg/kg (HL) | 5 | |
| Overall Study | NOT COMPLETED | Brentuximab Vedotin 1.8 mg/kg (sALCL) | 3 |
Source ClinicalTrials.gov
Adverse events202
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 | Alanine aminotransferase increased | Investigations | Brentuximab Vedotin 1.8 mg/kg (HL) | 18 | 30 | |
| other | Alanine aminotransferase increased | Investigations | Brentuximab Vedotin 1.8 mg/kg (sALCL) | 6 | 9 | |
| other | Aspartate aminotransferase increased | Investigations | Brentuximab Vedotin 1.8 mg/kg (HL) | 17 | 30 | |
| other | Aspartate aminotransferase increased | Investigations | Brentuximab Vedotin 1.8 mg/kg (sALCL) | 6 | 9 | |
| other | Gamma-glutamyltransferase increased | Investigations | Brentuximab Vedotin 1.8 mg/kg (HL) | 3 | 30 | |
| other | Gamma-glutamyltransferase increased | Investigations | Brentuximab Vedotin 1.8 mg/kg (sALCL) | 4 | 9 | |
| other | Blood bilirubin increased | Investigations | Brentuximab Vedotin 1.8 mg/kg (HL) | 0 | 30 | |
| other | Blood bilirubin increased | Investigations | Brentuximab Vedotin 1.8 mg/kg (sALCL) | 2 | 9 | |
| other | Total bile acids increased | Investigations | Brentuximab Vedotin 1.8 mg/kg (HL) | 0 | 30 | |
| other | Total bile acids increased | Investigations | Brentuximab Vedotin 1.8 mg/kg (sALCL) | 2 | 9 |
1 to 10 of 202Source ClinicalTrials.gov
See all 202 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brentuximab Vedotin 1.8 mg/kg (HL) | 4 | 30 |
| Total, all-cause mortality | Brentuximab Vedotin 1.8 mg/kg (sALCL) | 3 | 9 |
| Total, other adverse events | Brentuximab Vedotin 1.8 mg/kg (HL) | 30 | 30 |
| Total, other adverse events | Brentuximab Vedotin 1.8 mg/kg (sALCL) | 9 | 9 |
| Total, serious adverse events | Brentuximab Vedotin 1.8 mg/kg (HL) | 1 | 30 |
| Total, serious adverse events | Brentuximab Vedotin 1.8 mg/kg (sALCL) | 1 | 9 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34275403 | DERIVED |
Source PubMed
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Brentuximab Vedotin 1.8 mg/kg (HL) vs Brentuximab Vedotin 1.8 mg/kg (sALCL): Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Trial comparisons |
| Brentuximab Vedotin 1.8 mg/kg (HL) vs Brentuximab Vedotin 1.8 mg/kg (sALCL): deaths from any cause | Trial comparisons |
| Brentuximab Vedotin 1.8 mg/kg (HL) vs Brentuximab Vedotin 1.8 mg/kg (sALCL): 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.
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