Trial · NCT03947255
A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma
NCT03947255, Phase 2, Terminated, Seagen Inc.; results first posted 2023-10-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma. Trials, record NCT03947255. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03947255
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma
- NCT number
- NCT03947255
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Seagen Inc.
- Conditions
- Hodgkin Lymphoma, Peripheral T Cell Lymphoma, Anaplastic Large Cell Lymphoma
- Interventions
- brentuximab vedotin
- First posted
- 2019-05-13
- Last updated
- 2023-10-13
- Results first posted
- 2023-10-13
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria | Up to 18.3 months | Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on BICR |
| Primary | Number of Participants With Adverse Events | Up to 36 months | An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs) are defined as events that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. |
| Primary | Number of Participants With Laboratory Abnormalities | Up to 36 months | Laboratory data was summarized by the worst post-baseline grade, by NCI CTCAE v5.0 or higher for each parameter. |
| Secondary | Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria | Up to 17.1 months | Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first. |
| Secondary | Progression-free Survival (PFS) Per BICR According to Modified Lugano Response Criteria | up to 18.3 months | PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first. |
| Secondary | Overall Survival (OS) | Up to 35.8 months | OS is defined as the time from date of enrollment to date of death due to any cause. |
| Secondary | Rate of Complete Response (CR) Per BICR According to Modified Lugano Response Criteria | Up to 18.3 months | CR rate is defined as the percentage of participants with CR according to the modified Lugano Criteria for Response Assessment (Cheson 2014) |
| Secondary | ORR Per Investigator Assessment According to Modified Lugano Response Criteria | Up to 18.3 months | Objective Response Rate (ORR) is defined as the percentage of participants with CR or PR according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on investigator assessment |
| Secondary | DOR Per Investigator Assessment According to Modified Lugano Response Criteria | Up to 17.1 months | Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first. |
| Secondary | Progression-free Survival Per Investigator Assessment According to Modified Lugano Response Criteria | Up to 18.3 months | PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria | Up to 18.3 months | The full analysis set includes participants who received at least one dose of study treatment. | percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Adverse Events | Up to 36 months | The full analysis set includes participants who received at least one dose of study treatment. | Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria | Up to 17.1 months | The full analysis set includes participants who received at least one dose of study treatment. This is a subset analysis of participants with complete response or partial response. | months | MEDIAN |
| PRIMARY | Number of Participants With Laboratory Abnormalities | Up to 36 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival (PFS) Per BICR According to Modified Lugano Response Criteria | up to 18.3 months | The full analysis set includes participants who received at least one dose of study treatment. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to 35.8 months | The full analysis set includes participants who received at least one dose of study treatment. | Months | MEDIAN |
| SECONDARY | Rate of Complete Response (CR) Per BICR According to Modified Lugano Response Criteria | Up to 18.3 months | The full analysis set includes participants who received at least one dose of study treatment. | Percentage of Participants | NUMBER |
| SECONDARY | ORR Per Investigator Assessment According to Modified Lugano Response Criteria | Up to 18.3 months | The full analysis set includes participants who received at least one dose of study treatment. | Percentage of Participants | NUMBER |
| SECONDARY | DOR Per Investigator Assessment According to Modified Lugano Response Criteria | Up to 17.1 months | The full analysis set includes participants who received at least one dose of study treatment. This is a subset analysis of participants with complete response or partial response. | Months | MEDIAN |
| SECONDARY | Progression-free Survival Per Investigator Assessment According to Modified Lugano Response Criteria | Up to 18.3 months | The full analysis set includes participants who received at least one dose of study treatment. | Months | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group128
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria | Classic Hodgkin Lymphoma | 40.0 | 95% Confidence Interval 5.3 to 85.3 | percentage of participants | |
| Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria | PTCL | 83.3 | 95% Confidence Interval 35.9 to 99.6 | percentage of participants | |
| Number of Participants With Adverse Events | Classic Hodgkin Lymphoma | Any TEAE | 5 | Participants | |
| Number of Participants With Adverse Events | PTCL | Any TEAE | 6 | Participants | |
| Number of Participants With Adverse Events | Classic Hodgkin Lymphoma | Treatment-related TEAE | 4 | Participants | |
| Number of Participants With Adverse Events | PTCL | Treatment-related TEAE | 5 | Participants | |
| Number of Participants With Adverse Events | Classic Hodgkin Lymphoma | Any Treatment-Emergent SAE | 0 | Participants | |
| Number of Participants With Adverse Events | PTCL | Any Treatment-Emergent SAE | 2 | Participants | |
| Number of Participants With Adverse Events | Classic Hodgkin Lymphoma | Discontinuation of treatment due to TEAE | 1 | Participants | |
| Number of Participants With Adverse Events | PTCL | Discontinuation of treatment due to TEAE | 3 | Participants |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Classic Hodgkin Lymphoma | 6 | |
| Overall Study | STARTED | PTCL | 6 | |
| Overall Study | COMPLETED | Classic Hodgkin Lymphoma | 0 | |
| Overall Study | COMPLETED | PTCL | 0 | |
| Overall Study | NOT COMPLETED | Classic Hodgkin Lymphoma | 6 | |
| Overall Study | NOT COMPLETED | PTCL | 6 |
Source ClinicalTrials.gov
Adverse events68
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 | Neutropenia | Blood and lymphatic system disorders | Classic Hodgkin Lymphoma | 0 | 5 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | PTCL | 2 | 6 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | Classic Hodgkin Lymphoma | 0 | 5 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | PTCL | 1 | 6 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Classic Hodgkin Lymphoma | 0 | 5 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | PTCL | 1 | 6 | 1 |
| other | Nausea | Gastrointestinal disorders | Classic Hodgkin Lymphoma | 2 | 5 | 2 |
| other | Nausea | Gastrointestinal disorders | PTCL | 1 | 6 | 1 |
| other | Chills | General disorders | Classic Hodgkin Lymphoma | 0 | 5 | 0 |
| other | Chills | General disorders | PTCL | 1 | 6 | 1 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Classic Hodgkin Lymphoma | 0 | 6 |
| Total, all-cause mortality | PTCL | 2 | 6 |
| Total, other adverse events | Classic Hodgkin Lymphoma | 5 | 5 |
| Total, other adverse events | PTCL | 6 | 6 |
| Total, serious adverse events | Classic Hodgkin Lymphoma | 0 | 5 |
| Total, serious adverse events | PTCL | 2 | 6 |
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 |
|---|---|
| Classic Hodgkin Lymphoma vs PTCL: deaths from any cause | Trial comparisons |
| Classic Hodgkin Lymphoma vs PTCL: 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/NCT03947255
GET https://conductscience.org/api/trials/v1/NCT03947255/results?page=2