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

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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

February 2021