Trial · NCT01716806
A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)
NCT01716806, Phase 2, Completed, Seagen Inc.; results first posted 2024-06-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL). Trials, record NCT01716806. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01716806
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)
- NCT number
- NCT01716806
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 131 participants, actual
- Lead sponsor
- Seagen Inc.
- Conditions
- Hodgkin Disease, Peripheral T Cell Lymphoma
- Interventions
- brentuximab vedotin, bendamustine, dacarbazine, nivolumab
- First posted
- 2012-10-30
- Last updated
- 2024-06-11
- Results first posted
- 2024-06-11
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C) | Up to 81 months | Objective response rate (ORR) per investigator was defined as the percentage of subjects with complete response (CR) or partial response (PR) through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts A, B, and C the response was assessed using the Revised Response Criteria for Malignant Lymphoma (Cheson 2007). |
| Primary | ORR According to the Lugano Classification Revised Staging System for Nodal Non-Hodgkin and Hodgkin Lymphomas (Lugano Criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D) | Up to 60 months | Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Part D, the response was assessed using the Lugano Classification Revised Staging System for nodal non-Hodgkin and cHL (Lugano criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC). |
| Primary | ORR According to Modified Lugano Criteria Per Blinded Independent Central Review (BICR) (Parts E and F) | Up to 31 months | Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts E and F, the response was assessed per blinded independent central review (BICR) using the modified Lugano criteria. |
| Secondary | Number of Participants With Adverse Events | Up to 122 months | A treatment-emergent AE (TEAE) is defined as a newly occurring or worsening AE after the first dose of any study drug component. Treatment-related AEs are defined as treatment-emergent AEs that are determined by the investigator to be related to the treatment on study. TEAEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE. |
| Secondary | Number of Participants With Laboratory Abnormalities | Up to 30 months | Laboratory values were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE. |
| Secondary | Complete Response Rate | Up to 81 months | Complete response rate is defined as the percentage of patients with CR |
| Secondary | Duration of Complete Response | Up to 81 months | Duration of CR per investigator was defined as the time from start of the first documentation of CR to the first documentation of tumor progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR. |
| Secondary | Duration of Objective Response | Up to 81 months | Duration of response per investigator was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (PD) based on radiographic evidence of progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR. |
| Secondary | Progression-free Survival | Up to 83 months | Progression-free survival (PFS) per investigator was defined as the time from start of study treatment to first documentation of tumor progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR. |
| Secondary | Disease Control Rate | Up to 81 months | Disease control rate (DCR) per investigator was defined as the percentage of subjects with CR, PR, or SD, per investigator assessment of best clinical response per Cheson 2007. For Parts E and F, the assessment was per BICR. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
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) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C) | Up to 81 months | All subjects who received at least one dose of study drug | Percentage of participants | NUMBER |
| PRIMARY | ORR According to the Lugano Classification Revised Staging System for Nodal Non-Hodgkin and Hodgkin Lymphomas (Lugano Criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D) | Up to 60 months | All subjects who received at least one dose of study drug | Percentage of participants | NUMBER |
| PRIMARY | ORR According to Modified Lugano Criteria Per Blinded Independent Central Review (BICR) (Parts E and F) | Up to 31 months | All subjects who received at least one dose of study drug | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events | Up to 122 months | All subjects who received at least one dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Abnormalities | Up to 30 months | All subjects who received at least one dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Complete Response Rate | Up to 81 months | All subjects who received at least one dose of study drug | Percentage of participants | NUMBER |
| SECONDARY | Duration of Complete Response | Up to 81 months | All subjects with CR | Months | MEDIAN |
| SECONDARY | Duration of Objective Response | Up to 81 months | All subjects with CR/PR | Months | MEDIAN |
| SECONDARY | Progression-free Survival | Up to 83 months | All subjects who received at least one dose of study drug | Months | MEDIAN |
| SECONDARY | Disease Control Rate | Up to 81 months | All subjects who received at least one dose of study drug | Percentage of participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group770
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) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C) | Part A | 93 | 95% Confidence Interval 75.7 to 99.1 | Percentage of participants | |
| Objective Response Rate (ORR) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C) | Part B | 95 | 95% Confidence Interval 77.2 to 99.9 | Percentage of participants | |
| Objective Response Rate (ORR) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C) | Part C | 85 | 95% Confidence Interval 62.1 to 96.8 | Percentage of participants | |
ORR According to the Lugano Classification Revised Staging System for Nodal Non-Hodgkin and Hodgkin Lymphomas (Lugano Criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D) | Part D | 86 | 95% Confidence Interval 63.7 to 97.0 | Percentage of participants | |
| ORR According to Modified Lugano Criteria Per Blinded Independent Central Review (BICR) (Parts E and F) | Part E | 60 | 95% Confidence Interval 40.6 to 77.3 | Percentage of participants | |
| ORR According to Modified Lugano Criteria Per Blinded Independent Central Review (BICR) (Parts E and F) | Part F | 43 | 95% Confidence Interval 9.9 to 81.6 | Percentage of participants | |
| Number of Participants With Adverse Events | Part A | Any TEAE | 27 | Participants | |
| Number of Participants With Adverse Events | Part B | Any TEAE | 22 | Participants | |
| Number of Participants With Adverse Events | Part C | Any TEAE | 20 | Participants | |
| Number of Participants With Adverse Events | Part D | Any TEAE | 21 | Participants |
1 to 10 of 770Source ClinicalTrials.gov
See all 770 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A | 28 | |
| Overall Study | STARTED | Part B | 22 | |
| Overall Study | STARTED | Part C | 22 | |
| Overall Study | STARTED | Part D | 21 | |
| Overall Study | STARTED | Part E | 31 | |
| Overall Study | STARTED | Part F | 7 | |
| Overall Study | Received at Least One Dose of Study Drug | Part A | 27 | |
| Overall Study | Received at Least One Dose of Study Drug | Part B | 22 | |
| Overall Study | Received at Least One Dose of Study Drug | Part C | 20 | |
| Overall Study | Received at Least One Dose of Study Drug | Part D | 21 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,050
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 | Part A | 2 | 27 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Part B | 2 | 22 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Part C | 3 | 20 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Part D | 2 | 21 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Part E | 1 | 30 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Part F | 1 | 7 | 2 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Part A | 0 | 27 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Part B | 0 | 22 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Part C | 1 | 20 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Part D | 0 | 21 | 0 |
1 to 10 of 1,050Source ClinicalTrials.gov
See all 1,050 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A | 13 | 27 |
| Total, all-cause mortality | Part B | 9 | 22 |
| Total, all-cause mortality | Part C | 12 | 20 |
| Total, all-cause mortality | Part D | 4 | 21 |
| Total, all-cause mortality | Part E | 10 | 30 |
| Total, all-cause mortality | Part F | 5 | 7 |
| Total, other adverse events | Part A | 27 | 27 |
| Total, other adverse events | Part B | 22 | 22 |
| Total, other adverse events | Part C | 20 | 20 |
| Total, other adverse events | Part D | 21 | 21 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers4
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/NCT01716806
GET https://conductscience.org/api/trials/v1/NCT01716806/results?page=2