Trial · NCT01777152
ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas
NCT01777152, Phase 3, Completed, Seagen Inc.; results first posted 2019-07-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas. Trials, record NCT01777152. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01777152
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas
- NCT number
- NCT01777152
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 452 participants, actual
- Lead sponsor
- Seagen Inc.
- Conditions
- Anaplastic Large-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma
- Interventions
- brentuximab vedotin, doxorubicin, prednisone, vincristine, cyclophosphamide
- First posted
- 2013-01-28
- Last updated
- 2021-11-30
- Other registries' IDs
- eudract:2012-002751-42
- Results first posted
- 2019-07-30
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival Per Independent Review Facility (IRF) | Up to 60 months | The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first. |
| Secondary | Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL) | Up to 60 months | The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first. |
| Secondary | Complete Remission (CR) Rate Per IRF at End of Treatment (EOT) | Up to 8.34 months | The count of participants with CR per IRF following the completion of study treatment (at end of treatment or at the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma. |
| Secondary | Overall Survival (OS) | Up to 90 months | The time from randomization to death due to any cause. |
| Secondary | Objective Response Rate (ORR) Per IRF at End of Treatment | Up to 8.34 months | The count of participants with CR or partial response (PR) per IRF following the completion of study treatment (at end of treatment or the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma. |
| Secondary | Incidence of Adverse Events (AEs) | Up to 8.28 months | Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. |
| Secondary | Incidence of Laboratory Abnormalities | Up to 8.28 months | Number of participants who experienced a Grade 3 or higher laboratory toxicity. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival Per Independent Review Facility (IRF) | Up to 60 months | The Intent-to-Treat (ITT) Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received. | months | MEDIAN |
| SECONDARY | Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL) | Up to 60 months | This analysis population includes only patients with systemic anaplastic large cell lymphoma (sALCL). | months | MEDIAN |
| SECONDARY | Complete Remission (CR) Rate Per IRF at End of Treatment (EOT) | Up to 8.34 months | The ITT Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | Up to 90 months | The Intent-to-Treat (ITT) Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Per IRF at End of Treatment | Up to 8.34 months | The ITT Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Adverse Events (AEs) | Up to 8.28 months | The Safety Analysis Set includes all patients who receive any amount of brentuximab vedotin or any component of CHOP. Treatment group will be determined using the actual treatment received, regardless of the randomization treatment assignment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Laboratory Abnormalities | Up to 8.28 months | The Safety Analysis Set includes all patients who receive any amount of brentuximab vedotin or any component of CHOP. Treatment group will be determined using the actual treatment received, regardless of the randomization treatment assignment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival Per Independent Review Facility (IRF) | A+CHP | 48.20 | Inter-Quartile Range 8.87 to NA | months | |
| Progression-free Survival Per Independent Review Facility (IRF) | CHOP | 20.80 | Inter-Quartile Range 4.70 to NA | months | |
| Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL) | A+CHP | 55.66 | Inter-Quartile Range 15.61 to NA | months | |
| Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL) | CHOP | 32.03 | Inter-Quartile Range 4.57 to NA | months | |
| Complete Remission (CR) Rate Per IRF at End of Treatment (EOT) | A+CHP | 153 | Participants | ||
| Complete Remission (CR) Rate Per IRF at End of Treatment (EOT) | CHOP | 126 | Participants | ||
| Overall Survival (OS) | A+CHP | NA | Full Range 0.0 to 86.5 | Months | |
| Overall Survival (OS) | CHOP | NA | Full Range 0.1 to 90.0 | Months | |
| Objective Response Rate (ORR) Per IRF at End of Treatment | A+CHP | 188 | Participants | ||
| Objective Response Rate (ORR) Per IRF at End of Treatment | CHOP | 163 | Participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A+CHP | 226 | |
| Overall Study | STARTED | CHOP | 226 | |
| Overall Study | COMPLETED | A+CHP | 131 | |
| Overall Study | COMPLETED | CHOP | 116 | |
| Overall Study | NOT COMPLETED | A+CHP | 95 | |
| Overall Study | NOT COMPLETED | CHOP | 110 |
Source ClinicalTrials.gov
Adverse events648
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+CHP | 87 | 223 | |
| other | Neutropenia | Blood and lymphatic system disorders | CHOP | 81 | 226 | |
| other | Neutropenia | Blood and lymphatic system disorders | A+CHP Subgroup | 0 | ||
| other | Anaemia | Blood and lymphatic system disorders | A+CHP | 64 | 223 | |
| other | Anaemia | Blood and lymphatic system disorders | CHOP | 49 | 226 | |
| other | Anaemia | Blood and lymphatic system disorders | A+CHP Subgroup | 0 | ||
| other | Thrombocytopenia | Blood and lymphatic system disorders | A+CHP | 21 | 223 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | CHOP | 14 | 226 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | A+CHP Subgroup | 0 | ||
| other | Leukopenia | Blood and lymphatic system disorders | A+CHP | 18 | 223 |
1 to 10 of 648Source ClinicalTrials.gov
See all 648 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A+CHP | 67 | 223 |
| Total, all-cause mortality | CHOP | 89 | 226 |
| Total, all-cause mortality | A+CHP Subgroup | 1 | 3 |
| Total, other adverse events | A+CHP | 220 | 223 |
| Total, other adverse events | CHOP | 218 | 226 |
| Total, other adverse events | A+CHP Subgroup | 0 | 0 |
| Total, serious adverse events | A+CHP | 89 | 223 |
| Total, serious adverse events | CHOP | 90 | 226 |
| Total, serious adverse events | A+CHP Subgroup | 0 | 0 |
Source ClinicalTrials.gov
Papers5
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| A+CHP vs CHOP: Objective Response Rate (ORR) Per IRF at End of Treatment | Trial comparisons |
| A+CHP vs CHOP: Complete Remission (CR) Rate Per IRF at End of Treatment (EOT) | 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/NCT01777152
GET https://conductscience.org/api/trials/v1/NCT01777152/results?page=2