A comparison of brentuximab vedotin and CHP with standard-of-care CHOP in the treatment of patients with CD30-positive mature T-cell lymphomas

A randomized, double-blind, placebo-controlled, phase 3 study of brentuximab vedotin and CHP (A+CHP) versus CHOP in the frontline treatment of patients with CD30-positive mature T-cell lymphomas - ECHELON-2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002751-42-CZ

Enrollment

300

Registered

2012-11-15

Start date

2013-02-13

Completion date

Unknown

Last updated

2020-12-07

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

Conditions

CD30-positive mature T-cell lymphomas MedDRA version: 18.1 Level: HLGT Classification code 10025321 Term: Lymphomas non-Hodgkin's T-cell System Organ Class: 10005329 - Blood and lymphatic system disorders

Interventions

Trade Name: Adcetris Product Name: Brentuximab vedotin Product Code: SGN-35 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Brentuximab vedotin CAS Number: 9

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - ECOG performance less than or equal to 2 - Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT - Patients with newly diagnosed, CD-30-positive mature T-cell lymphomas Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120

Exclusion criteria

Exclusion criteria: - Cerebral/meningeal disease related to the underlying malignancy - Current diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas or mycosis funoides - History of another primary invasive malignancy that has not been in remission for at least 3 years - History of progressive multifocal leukoencephalopathy (PML)

Design outcomes

Primary

Measure	Time frame
Main Objective: - To compare the progression-free survival (PFS) as determined by an independent review facility (IRF) between the 2 treatment arms;Secondary Objective: - To compare the PFS per IRF between the 2 treatment arms for patients with sALCL - To compare the remission rates per IRF following the completion of study treatment between the 2 treatment arms - To compare overall survival (OS) between the 2 treatment arms - To evaluate the safety and tolerability of the 2 treatment arms ;Primary end point(s): Progression-free survival per independent review facility (IRF);Timepoint(s) of evaluation of this end point: Until disease progression, subsequent anticancer chemotherapy, death, or study closure, up to 5 years post-treatment	—

Measure

Time frame

Main Objective: - To compare the progression-free survival (PFS) as determined by an independent review facility (IRF) between the 2 treatment arms;Secondary Objective: - To compare the PFS per IRF between the 2 treatment arms for patients with sALCL - To compare the remission rates per IRF following the completion of study treatment between the 2 treatment arms - To compare overall survival (OS) between the 2 treatment arms - To evaluate the safety and tolerability of the 2 treatment arms ;Primary end point(s): Progression-free survival per independent review facility (IRF);Timepoint(s) of evaluation of this end point: Until disease progression, subsequent anticancer chemotherapy, death, or study closure, up to 5 years post-treatment

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Secondary

Measure	Time frame
Secondary end point(s): 1. Progression-free survival per IRF in patients with sALCL 2. Complete remission rate per IRF at end of treatment 3. Overall survival 4. Objective response rate per IRF following the completion of study treatment 5. Type, incidence, severity, seriousness, and relatedness of adverse events 6. Incidence of laboratory abnormalities;Timepoint(s) of evaluation of this end point: 1. Until disease progression, subsequent anticancer chemotherapy, death, or study closure, up to 5 years post treatment 2. Through 1 month following last dose 3. Until death or study closure, up to 7-years post treatment 4. Through 1 month following last dose 5. Through 1 month following last dose 6. Through 1 month following last dose	—

Measure

Time frame

Secondary end point(s): 1. Progression-free survival per IRF in patients with sALCL 2. Complete remission rate per IRF at end of treatment 3. Overall survival 4. Objective response rate per IRF following the completion of study treatment 5. Type, incidence, severity, seriousness, and relatedness of adverse events 6. Incidence of laboratory abnormalities;Timepoint(s) of evaluation of this end point: 1. Until disease progression, subsequent anticancer chemotherapy, death, or study closure, up to 5 years post treatment 2. Through 1 month following last dose 3. Until death or study closure, up to 7-years post treatment 4. Through 1 month following last dose 5. Through 1 month following last dose 6. Through 1 month following last dose

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Countries

Australia, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Poland, Romania, Spain, Taiwan, United Kingdom, United States

Contacts

Public ContactMiguelle Doki-Thonon

Pharmaceutical Research Associates

DokiThononMiguelle@PRAIntl.com+3314318 8304-

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026