Trial · NCT01712490
A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma
NCT01712490, Phase 3, Completed, Takeda; results first posted 2018-11-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma. Trials, record NCT01712490. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01712490
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma
- NCT number
- NCT01712490
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,334 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Hodgkin Lymphoma
- Interventions
- brentuximab vedotin, doxorubicin, bleomycin, vinblastine, dacarbazine
- First posted
- 2012-10-23
- Last updated
- 2026-02-27
- Other registries' IDs
- eudract:2011-005450-60
- Results first posted
- 2018-11-27
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF) | Baseline until PD or death or receipt of any subsequent anticancer therapy for HL after completion of frontline therapy (approximately up to 4 years) | mPFS was defined as the time from the date of randomization to the date of the first of documentation of progressive disease (PD), death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for Hodgkin lymphoma (HL) after completion of frontline therapy. PD was defined as any new lesion or increase by greater than or equal to (\>=) 50 percent (%) of previously involved sites from nadir. Frontline therapy is the part of standard set of treatments. |
| Secondary | Overall Survival (OS) | Baseline until death (approximately up to 4 years) | OS was defined as the time from the date of randomization to the date of death. Participants without documented death at the time of analysis were censored at the date last known to be alive. |
| Secondary | Complete Remission (CR) Rate at the End of Randomized Regimen Per IRF | Baseline up to end of randomized regimen (approximately 1 year) | CR rate at the end of randomized regimen per investigator was defined as the percentage of participants who achieved CR at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by IRF. CR was defined as disappearance of all evidence of disease. |
| Secondary | Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | Baseline up to 30 days after last dose of study drug (approximately 1 year) | |
| Secondary | Number of Participants With Abnormal Clinical Laboratory Values | Baseline up to 30 days after last dose of study drug (approximately 1 year) | |
| Secondary | Event-free Survival (EFS) Per IRF | Baseline until PD or discontinuation of treatment or death, whichever occurs first (approximately up to 4 years) | EFS was defined as the time from randomization until any cause of treatment failure: PD, premature discontinuation of randomized treatment for any reason, or death due to any cause, whichever occurs first. PD was defined as any new lesion or increase by \>=50% of previously involved sites from nadir per IRF. |
| Secondary | Disease-free Survival (DFS) Per IRF | From CR until PD or death (approximately up to 4 years) | DFS per IRF was defined as the time from CR to disease progression as determined by an IRF or to death from lymphoma or acute toxicity from treatment. CR was defined as disappearance of all evidence of disease. |
| Secondary | Overall Response Rate (ORR) Per IRF | Baseline up to end of randomized regimen (approximately 1 year) | ORR per IRF was defined as the percentage of participants who achieved CR or partial remission (PR) at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by an IRF. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites. |
| Secondary | Duration of Response (DOR) Per IRF | From first documented response until PD (approximately 4 years) | DOR per IRF in participants with response was the time between first documentation of response (PR or CR) and PD as determined by an IRF. PD was defined as any new lesion or increase by \>=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites. |
| Secondary | Duration of Complete Remission (DOCR) Per IRF | From first documentation of CR until PD (approximately 4 years) | DOCR per IRF in participants with CR was the time between first documentation of CR and PD as determined by an IRF. PD was defined as any new lesion or increase by \>=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease. |
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 | Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF) | Baseline until PD or death or receipt of any subsequent anticancer therapy for HL after completion of frontline therapy (approximately up to 4 years) | The ITT population included all participants randomized to treatment. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Baseline until death (approximately up to 4 years) | The ITT population included all participants randomized to treatment. | months | MEDIAN |
| SECONDARY | Complete Remission (CR) Rate at the End of Randomized Regimen Per IRF | Baseline up to end of randomized regimen (approximately 1 year) | The ITT population included all participants randomized to treatment. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | Baseline up to 30 days after last dose of study drug (approximately 1 year) | The safety population included all enrolled participants who received at least 1 dose of any study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Abnormal Clinical Laboratory Values | Baseline up to 30 days after last dose of study drug (approximately 1 year) | The safety population included all enrolled participants who received at least 1 dose of any study drug. | participants | NUMBER |
| SECONDARY | Event-free Survival (EFS) Per IRF | Baseline until PD or discontinuation of treatment or death, whichever occurs first (approximately up to 4 years) | The ITT population included all participants randomized to treatment. | months | MEDIAN |
| SECONDARY | Disease-free Survival (DFS) Per IRF | From CR until PD or death (approximately up to 4 years) | The ITT included all participants randomized to treatment. The ITT population where participants achieved CR. | months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) Per IRF | Baseline up to end of randomized regimen (approximately 1 year) | The ITT population included all participants randomized to treatment. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Per IRF | From first documented response until PD (approximately 4 years) | The ITT population included all participants randomized to treatment. The ITT population where participants achieved confirmed response of CR or PR. | months | MEDIAN |
| SECONDARY | Duration of Complete Remission (DOCR) Per IRF | From first documentation of CR until PD (approximately 4 years) | The ITT population included all participants randomized to treatment. The ITT population where participants achieved CR. | months | MEDIAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group47
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF) | A+AVD | NA | 95% Confidence Interval 48.2 to NA | months | |
| Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF) | ABVD | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival (OS) | A+AVD | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival (OS) | ABVD | NA | 95% Confidence Interval NA to NA | months | |
| Complete Remission (CR) Rate at the End of Randomized Regimen Per IRF | A+AVD | 73 | percentage of participants | ||
| Complete Remission (CR) Rate at the End of Randomized Regimen Per IRF | ABVD | 70 | percentage of participants | ||
| Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | A+AVD | TEAE | 653 | participants | |
| Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | ABVD | TEAE | 646 | participants | |
| Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | A+AVD | SAE | 284 | participants | |
| Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | ABVD | SAE | 178 | participants |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A+AVD | 664 | |
| Overall Study | STARTED | ABVD | 670 | |
| Overall Study | Treated | A+AVD | 662 | |
| Overall Study | Treated | ABVD | 659 | |
| Overall Study | COMPLETED | A+AVD | 0 | |
| Overall Study | COMPLETED | ABVD | 0 | |
| Overall Study | NOT COMPLETED | A+AVD | 664 | |
| Overall Study | NOT COMPLETED | ABVD | 670 |
Source ClinicalTrials.gov
Adverse events592
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 | A+AVD | 374 | 662 | 1,169 |
| other | Neutropenia | Blood and lymphatic system disorders | ABVD | 291 | 659 | 813 |
| other | Anaemia | Blood and lymphatic system disorders | A+AVD | 136 | 662 | 237 |
| other | Anaemia | Blood and lymphatic system disorders | ABVD | 65 | 659 | 97 |
| other | Leukopenia | Blood and lymphatic system disorders | A+AVD | 42 | 662 | 124 |
| other | Leukopenia | Blood and lymphatic system disorders | ABVD | 37 | 659 | 118 |
| other | Nausea | Gastrointestinal disorders | A+AVD | 346 | 662 | 673 |
| other | Nausea | Gastrointestinal disorders | ABVD | 369 | 659 | 735 |
| other | Constipation | Gastrointestinal disorders | A+AVD | 273 | 662 | 361 |
| other | Constipation | Gastrointestinal disorders | ABVD | 239 | 659 | 336 |
1 to 10 of 592Source ClinicalTrials.gov
See all 592 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A+AVD | 9 | 662 |
| Total, all-cause mortality | ABVD | 13 | 659 |
| Total, other adverse events | A+AVD | 644 | 662 |
| Total, other adverse events | ABVD | 632 | 659 |
| Total, serious adverse events | A+AVD | 284 | 662 |
| Total, serious adverse events | ABVD | 178 | 659 |
Source ClinicalTrials.gov
Papers9
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| A+AVD vs ABVD: Number of Participants With Abnormal Clinical Laboratory Values | Trial comparisons |
| A+AVD vs ABVD: deaths from any cause | Trial comparisons |
| A+AVD vs ABVD: 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/NCT01712490
GET https://conductscience.org/api/trials/v1/NCT01712490/results?page=2