Brief 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
Official Title
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
Brief 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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Progression-free Survival Per Independent Review Facility (IRF)
Secondary Outcome
Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)
Condition
Anaplastic Large-Cell Lymphoma
Intervention
brentuximab vedotin
Study Arms / Comparison Groups
CHOP
Description: cyclophosphamide, doxorubicin, vincristine, and prednisone
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
452
Start Date
January 31, 2013
Completion Date
October 2, 2020
Primary Completion Date
August 15, 2018
Eligibility Criteria
Inclusion Criteria: - Patients with newly diagnosed, CD30-positive mature T-cell lymphomas - Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT - Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 Exclusion Criteria: - History of another primary invasive malignancy that has not been in remission for at least 3 years - Current diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas or mycosis fungoides - History of progressive multifocal leukoencephalopathy (PML) - Cerebral/meningeal disease related to the underlying malignancy
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Thomas Manley, MD, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT01777152
Organization ID
SGN35-014
Secondary IDs
2012-002751-42
Responsible Party
Sponsor
Study Sponsor
Seagen Inc.
Collaborators
Millennium Pharmaceuticals, Inc.
Study Sponsor
Thomas Manley, MD, Study Director, Seagen Inc.
Verification Date
November 2021