Trial · NCT03646123
Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma
NCT03646123, Phase 2, Terminated, Seagen Inc.; results first posted 2023-12-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma. Trials, record NCT03646123. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03646123
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma
- NCT number
- NCT03646123
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 255 participants, actual
- Lead sponsor
- Seagen Inc.
- Conditions
- Hodgkin Lymphoma
- Interventions
- brentuximab vedotin, doxorubicin, vinblastine, dacarbazine, G-CSF, nivolumab
- First posted
- 2018-08-24
- Last updated
- 2025-08-28
- Results first posted
- 2023-12-21
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Febrile Neutropenia (FN) Rate (Part A) | 7.5 months | The FN rate is defined as the number of participants who experience treatment-emergent FN. |
| Primary | Complete Response (CR) Rate at EOT (Parts B and C) | 7.8 months | CR rate at EOT is defined as the percentage of participants with CR at EOT, according to the Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Cheson 2016), in participants with previously untreated cHL. |
| Secondary | Number of Participants With Adverse Events of Clinical Interest (AECI) (Part A) | Approximately up to 7.5 months | An adverse event (AE) was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with the treatment. Participants with peripheral neuropathy (PN) adverse events were summarized under AECI. |
| Secondary | Primary Refractory Disease Rate (Part A) | 10.2 months | The primary refractory disease rate is defined as the percentage of participants with less than complete response or relapse within 3 months of EOT, according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas |
| Secondary | Complete Response Rate (Part A) | 7.2 months | The complete response rate is defined as the percentage of participants with CR at EOT according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas (Cheson 2014). |
| Secondary | Physician-reported Progression Free Survival (PFS) (Part A) | 24 months | The physician-reported PFS rate at 2 years is estimated based on Kaplan-Meier methodology. The determination of antitumor activity will be based on response assessments made according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas (Cheson 2014). |
| Secondary | Number of Participants With Subsequent Anticancer Therapy Utilization (Part A) | 33.8 months | Number of participants with subsequent anticancer therapy have been reported in this outcome measure. |
| Secondary | Actual Dose Intensity: Brentuximab Vedotin (Part A) | 6.5 months | |
| Secondary | Actual Dose Intensity: Doxorubicin, Vinblastine, Dacarbazine (Part A) | 6.5 months | |
| Secondary | Relative Dose Intensity (Part A) | 6.5 months |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Febrile Neutropenia (FN) Rate (Part A) | 7.5 months | For Part A, the full analysis set included all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Complete Response (CR) Rate at EOT (Parts B and C) | 7.8 months | For Parts B and C, the full analysis set included all participants who enrolled and received any amount of the combination therapy in the study. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events of Clinical Interest (AECI) (Part A) | Approximately up to 7.5 months | For Part A, the full analysis set included all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Primary Refractory Disease Rate (Part A) | 10.2 months | For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | percentage of participants | NUMBER |
| SECONDARY | Complete Response Rate (Part A) | 7.2 months | For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | percentage of participants | NUMBER |
| SECONDARY | Physician-reported Progression Free Survival (PFS) (Part A) | 24 months | For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Subsequent Anticancer Therapy Utilization (Part A) | 33.8 months | For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Actual Dose Intensity: Brentuximab Vedotin (Part A) | 6.5 months | For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | mg/kg/week | MEAN |
| SECONDARY | Actual Dose Intensity: Doxorubicin, Vinblastine, Dacarbazine (Part A) | 6.5 months | For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | mg/m2/week | MEAN |
| SECONDARY | Relative Dose Intensity (Part A) | 6.5 months | For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | percentage of intended dose | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group384
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Febrile Neutropenia (FN) Rate (Part A) | Part A | Any treatment-emergent FN | 5 | Participants | |
| Febrile Neutropenia (FN) Rate (Part A) | Part A | Treatment-related treatment-emergent FN | 5 | Participants | |
| Febrile Neutropenia (FN) Rate (Part A) | Part A | Grade 3 or higher treatment-emergent FN | 5 | Participants | |
| Febrile Neutropenia (FN) Rate (Part A) | Part A | Grade 3 or higher treatment-related treatment-emergent FN | 5 | Participants | |
| Complete Response (CR) Rate at EOT (Parts B and C) | Part B | 88 | 95% Confidence Interval 76.3 to 94.9 | Percentage of participants | |
| Complete Response (CR) Rate at EOT (Parts B and C) | Part C | 92 | 95% Confidence Interval 86.0 to 95.4 | Percentage of participants | |
| Number of Participants With Adverse Events of Clinical Interest (AECI) (Part A) | Part A | 32 | Participants | ||
| Primary Refractory Disease Rate (Part A) | Part A | 10 | 95% Confidence Interval 2.8 to 23.7 | percentage of participants | |
| Complete Response Rate (Part A) | Part A | 80 | 95% Confidence Interval 64.4 to 90.9 | percentage of participants | |
| Physician-reported Progression Free Survival (PFS) (Part A) | Part A | 89.23 | 95% Confidence Interval 73.76 to 95.82 | percentage of participants |
1 to 10 of 384Source ClinicalTrials.gov
See all 384 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A | 41 | |
| Overall Study | STARTED | Part B | 58 | |
| Overall Study | STARTED | Part C | 156 | |
| Overall Study | Treated | Part A | 40 | |
| Overall Study | Treated | Part B | 57 | |
| Overall Study | Treated | Part C | 154 | |
| Overall Study | COMPLETED | Part A | 31 | |
| Overall Study | COMPLETED | Part B | 0 | |
| Overall Study | COMPLETED | Part C | 1 | |
| Overall Study | NOT COMPLETED | Part A | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,461
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 | 4 | 40 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Part B | 6 | 57 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Part C | 8 | 154 | 10 |
| other | Anaemia folate deficiency | Blood and lymphatic system disorders | Part A | 1 | 40 | 1 |
| other | Anaemia folate deficiency | Blood and lymphatic system disorders | Part B | 0 | 57 | 0 |
| other | Anaemia folate deficiency | Blood and lymphatic system disorders | Part C | 0 | 154 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Part A | 0 | 40 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Part B | 0 | 57 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Part C | 2 | 154 | 5 |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Part A | 0 | 40 | 0 |
1 to 10 of 1,461Source ClinicalTrials.gov
See all 1,461 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A | 2 | 40 |
| Total, all-cause mortality | Part B | 1 | 57 |
| Total, all-cause mortality | Part C | 1 | 154 |
| Total, other adverse events | Part A | 40 | 40 |
| Total, other adverse events | Part B | 57 | 57 |
| Total, other adverse events | Part C | 153 | 154 |
| Total, serious adverse events | Part A | 19 | 40 |
| Total, serious adverse events | Part B | 15 | 57 |
| Total, serious adverse events | Part C | 29 | 154 |
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/NCT03646123
GET https://conductscience.org/api/trials/v1/NCT03646123/registered?page=2