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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2021-11-30

Study results available
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Summary

This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care CHOP in patients with CD30-positive mature T-cell lymphomas.

Conditions

Interventions

DRUG

brentuximab vedotin

1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles

DRUG

doxorubicin

50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

DRUG

prednisone

100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles

DRUG

vincristine

1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles

DRUG

cyclophosphamide

750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY
  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Manley, MD · Seagen Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2018-08-15
Completion
2020-10-02

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Poland
  • Romania
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01777152 on ClinicalTrials.gov