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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Lymphoma, T-Cell	Drug: cyclophosphamide Drug: doxorubicin Drug: vincristine Drug: prednisone Drug: brentuximab vedotin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma Steroids

Drug Information available for: Cyclophosphamide Prednisone Vincristine sulfate Doxorubicin Doxorubicin hydrochloride Brentuximab vedotin

U.S. FDA Resources

Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:

Progression-free survival per independent review facility (IRF) [ Time Frame: Until disease progression, subsequent anticancer chemotherapy, death, or study closure, up to 5 years post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival per IRF in patients with systemic anaplastic large cell lymphoma (sALCL) [ Time Frame: Until disease progression, subsequent anticancer chemotherapy, death, or study closure, up to 5 years post-treatment ] [ Designated as safety issue: No ]
Complete remission rate per IRF at end of treatment [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Until death or study closure, up to 7 years post-treatment ] [ Designated as safety issue: No ]
Objective response rate per IRF at end of treatment [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
Type, incidence, severity, seriousness, and relatedness of adverse events [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	January 2013
Estimated Study Completion Date:	December 2019
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Standard-of-care	Drug: cyclophosphamide 750 mg/m2 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: vincristine 1.4 mg/m2 (maximum 2 mg) 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
Active Comparator: Experimental	Drug: cyclophosphamide 750 mg/m2 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: brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles Other Name: SGN-35

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777152

Contacts

Contact: Terri Lowe

866-333-7436

clinicaltrials@seagen.com

Locations

United States, Alabama
University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States, 35294-1608
Contact: Ronda Carlisle 205-975-2511 rcarlisle@uab.edu
Principal Investigator: Naresh Bellam, MD
United States, California
Stanford Cancer Center	Recruiting
Stanford, California, United States, 94305-5821
Contact: Sipra Choudhury 650-736-2563 schoudhury@stanford.edu
Principal Investigator: Ranjana Advani, MD
United States, Florida
MD Anderson Cancer Center Orlando	Recruiting
Orlando, Florida, United States, 32806
Contact: Casey Kulscar 321-841-4347 casey.kulscar@orlandohealth.com
Principal Investigator: Jose Sarriera, M.D.
United States, Maryland
University of Maryland	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Patricia Lesho 410-328-2577 plesho@umm.edu
Principal Investigator: Amy Kimball, M.D.
United States, Minnesota
Park Nicollet Institute	Recruiting
St. Louis Park, Minnesota, United States, 55426
Contact: Laura Maybon 952-993-5710 Laura.Maybon@parknicollet.com
Principal Investigator: Kendra Kubiak, MD
United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Sarah Larson 314-362-3257 salarson@dom.wustl.edu
Principal Investigator: Nancy Bartlett, MD
United States, New Jersey
Hackensack University Medical Center	Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Kelly A. Azzollini 551-996-3277 kazzollini@hackensackumc.org
Principal Investigator: Tatyana Feldman, MD
United States, New York
Columbia University Medical Center	Recruiting
New York, New York, United States, 10019
Contact: Ameet Narwal 212-326-5732 an2284@columbia.edu
Principal Investigator: Owen A. O'Connor, M.D.; PhD
United States, Ohio
Jewish Hospital, The	Recruiting
Cincinnati, Ohio, United States, 45236
Contact: Chris Hensley 513-686-3385 mchensley@health-partners.org
Principal Investigator: Miguel Islas-Ohlmayer, MD
Cleveland Clinic, The	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Elizabeth Gazdick 216-445-8907 gazdice@ccf.org
Principal Investigator: Deepa Jagadeesh, M.D.
United States, Tennessee
Sarah Cannon Research Institute	Recruiting
Nashville, Tennessee, United States, 37203
Contact: Terri Lowe 866-333-7436 clinicaltrials@seagen.com
Principal Investigator: Ian Flinn, M.D.
United States, Texas
Charles A. Sammons Cancer Center	Recruiting
Dallas, Texas, United States, 75246
Contact: Erica Goetz 214-818-8325 erica.goetz@baylorhealth.edu
Principal Investigator: Estil Vance, M.D.
MD Anderson Cancer Center /The University of Texas	Recruiting
Houston, Texas, United States, 77030-4000
Contact: Toni Hutto 713-792-1871 thutto@mdanderson.org
Principal Investigator: Michelle Fanale, MD
United States, Virginia
Virginia Commonwealth University Medical Center	Recruiting
Richmond, Virginia, United States, 23298
Contact: Kathy (Kathryn) Candler 804-828-4732 kcandler@vcu.edu
Principal Investigator: John McCarty, MD
United States, Washington
Virginia Mason Medical Center	Recruiting
Seattle, Washington, United States, 98101
Contact: Ponce Leila 206-342-6926 Leila.Ponce@vmmc.org
Principal Investigator: David Aboulafia, M.D.
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Centre	Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Debbie Jepson 604-877-6000 local 3567 djepson@bccancer.bc.ca
Principal Investigator: Kerry Savage, M.D.

Sponsors and Collaborators

Seattle Genetics, Inc.

Millennium Pharmaceuticals, Inc.

Investigators

Study Director:

Dana Kennedy, PharmD

Seattle Genetics, Inc.

More Information

No publications provided

Responsible Party:	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT01777152 History of Changes
Other Study ID Numbers:	SGN35-014
Study First Received:	January 23, 2013
Last Updated:	May 14, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:

Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Drug Therapy
Hematologic Diseases
Lymphoma

Immunotherapy
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, Large-Cell, Anaplastic
Monomethyl auristatin E

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Cyclophosphamide
Doxorubicin
Prednisone

Vincristine
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on May 23, 2013