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
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
- Anaplastic Large-Cell Lymphoma
- Non-Hodgkin Lymphoma
- T-Cell Lymphoma
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
-
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
-
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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