Trial · NCT02139592
Brentuximab Vedotin (Recombinant) for IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"
NCT02139592, Completed, Takeda; results first posted 2019-05-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Brentuximab Vedotin (Recombinant) for IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma". Trials, record NCT02139592. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02139592
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brentuximab Vedotin (Recombinant) for IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"
- NCT number
- NCT02139592
- Status
- Completed
- Enrollment
- 292 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma
- Interventions
- Brentuximab vedotin (recombinant)
- First posted
- 2014-05-15
- Last updated
- 2020-07-13
- Results first posted
- 2019-05-06
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE) | Up to Week 48 or until discontinuation of treatment | |
| Secondary | Percentage of Participants Who Achieve or Maintain Any Best Response | Up to Week 48 or until discontinuation of treatment | Best response is defined as the cumulative numbers of participants who achieve each level of best response including partial response (PR), complete response uncertain (CRu) (when no positron emission tomography \[PET\] data are available), and complete response (CR) after each cycle of treatment. Reported data are divided into 4 populations; Hodgkin's lymphoma (HL) participants with PET data, HL participants without PET data, anaplastic large cell lymphoma (ALCL) participants with PET data, and ALCL participants without PET data. PET is used in cancer diagnosis and treatment. |
| Secondary | Overall Survival (OS) | Up to Week 48 or until discontinuation of treatment | OS is defined as the period from the start of therapy in standard medical care to the time when death (regardless of the cause of death) is confirmed. Reported data as OS was point estimates of 1 year survival rate for HL and ALCL participants. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE) | Up to Week 48 or until discontinuation of treatment | Safety Analysis Set; The safety analysis set was defined as all participants who had the safety data defined on the protocol. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Who Achieve or Maintain Any Best Response | Up to Week 48 or until discontinuation of treatment | Efficacy assessment population; The efficacy assessment population was defined as participants who met the requirement of this study and had efficacy data available for analysis. The number analyzed is the number of participants with data available for analysis in the given timeframe. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Up to Week 48 or until discontinuation of treatment | Efficacy assessment population; The efficacy assessment population was defined as participants who met the requirement of this study and had efficacy data available for analysis. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE) | Brentuximab Vedotin Infusion | AE | 238 | Participants | |
| Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE) | Brentuximab Vedotin Infusion | SAE | 97 | Participants | |
| Percentage of Participants Who Achieve or Maintain Any Best Response | Brentuximab Vedotin Infusion | HL Participants with PET Data | 64.9 | 95% Confidence Interval 53.22 to 75.47 | Percentage of participants |
| Percentage of Participants Who Achieve or Maintain Any Best Response | Brentuximab Vedotin Infusion | HL Participants without PET Data | 36.5 | 95% Confidence Interval 26.29 to 47.62 | Percentage of participants |
| Percentage of Participants Who Achieve or Maintain Any Best Response | Brentuximab Vedotin Infusion | ALCL Participants with PET Data | 67.6 | 95% Confidence Interval 50.21 to 81.99 | Percentage of participants |
| Percentage of Participants Who Achieve or Maintain Any Best Response | Brentuximab Vedotin Infusion | ALCL Participants without PET Data | 57.1 | 95% Confidence Interval 40.96 to 72.28 | Percentage of participants |
| Overall Survival (OS) | Brentuximab Vedotin Infusion | HL Participants | 82.7 | 95% Confidence Interval 75.4 to 88.0 | Percentage of participants |
| Overall Survival (OS) | Brentuximab Vedotin Infusion | ALCL Participants | 79.3 | 95% Confidence Interval 68.4 to 86.7 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Brentuximab Vedotin Infusion | 292 | |
| Overall Study | COMPLETED | Brentuximab Vedotin Infusion | 284 | |
| Overall Study | NOT COMPLETED | Brentuximab Vedotin Infusion | 8 |
Source ClinicalTrials.gov
Adverse events85
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 | Lymphopenia | Blood and lymphatic system disorders | Brentuximab Vedotin Infusion | 22 | 284 | |
| other | Neutropenia | Blood and lymphatic system disorders | Brentuximab Vedotin Infusion | 153 | 284 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Brentuximab Vedotin Infusion | 17 | 284 | |
| other | Peripheral sensory neuropathy | Nervous system disorders | Brentuximab Vedotin Infusion | 129 | 284 | |
| other | Rash | Skin and subcutaneous tissue disorders | Brentuximab Vedotin Infusion | 15 | 284 | |
| other | Pyrexia | General disorders | Brentuximab Vedotin Infusion | 15 | 284 | |
| other | Infusion related reaction | Injury, poisoning and procedural complications | Brentuximab Vedotin Infusion | 31 | 284 | |
| serious | Bacteraemia | Infections and infestations | Brentuximab Vedotin Infusion | 1 | 284 | |
| serious | Epstein-Barr virus infection | Infections and infestations | Brentuximab Vedotin Infusion | 1 | 284 | |
| serious | Cytomegalovirus infection | Infections and infestations | Brentuximab Vedotin Infusion | 2 | 284 |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brentuximab Vedotin Infusion | 51 | 284 |
| Total, other adverse events | Brentuximab Vedotin Infusion | 238 | 284 |
| Total, serious adverse events | Brentuximab Vedotin Infusion | 97 | 284 |
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 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/NCT02139592
GET https://conductscience.org/api/trials/v1/NCT02139592/events?page=2