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C5691003_A Randomized, Double-blind, Placebo-Controlled, Active-Comparator, Multicenter, Phase 3 Study of Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) ECHELON-3

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503384-41-00
Acronym
SGN35-031
Enrollment
84
Registered
2023-10-13
Start date
2020-12-22
Completion date
Unknown
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Brief summary

OS (Overall Survival)

Detailed description

PFS (progression-free survival) per Lugano 2014 by investigator, CR (complete response) rate per Lugano 2014 by investigator, DOR (duration of response) per Lugano 2014 by investigator, Incidence, severity, and seriousness of adverse events (AEs) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, OS in CD30-positive participants, ORR (objective response rate) per Lugano 2014 by investigator

Interventions

DRUGRITUXIMAB
DRUGBRENTUXIMAB VEDOTIN
DRUGPlacebo BRENTUXIMAB"VEDOTIN"
DRUGRevlimid 5 mg hard capsules

Sponsors

Seagen Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
OS (Overall Survival)—

Secondary

MeasureTime frame
PFS (progression-free survival) per Lugano 2014 by investigator, CR (complete response) rate per Lugano 2014 by investigator, DOR (duration of response) per Lugano 2014 by investigator, Incidence, severity, and seriousness of adverse events (AEs) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, OS in CD30-positive participants, ORR (objective response rate) per Lugano 2014 by investigator—

Countries

Belgium, Czechia, Denmark, France, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026