Last updated on July 2018

Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma

Brief description of study

This is a Phase 2 study to evaluate the combination of denintuzumab mafodotin in combination with RCHOP or RCHP compared with RCHOP alone as front-line therapy in patients with diffuse large B-cell lymphoma or follicular lymphoma Grade 3b.

Detailed Study Description

In Part A of the study, patients will be randomized 1:1 to receive denintuzumab mafodotin plus RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) or denintuzumab mafodotin plus RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) to assess the safety of these 2 combination regimens. Part B of the study is designed to evaluate the antitumor activity and safety of denintuzumab mafodotin in combination with either RCHOP or RCHP (Experimental Arm) compared with RCHOP alone (Comparator Arm).

Clinical Study Identifier: NCT02855359

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Amitkumar Mehta, MD

University of Alabama at Birmingham
Birmingham, AL United States

Marc Monte, MD

Saint Bernards Cancer Center
Jonesboro, AR United States

Elizabeth Budde, MD

City of Hope
Duarte, CA United States

Haresh Jhangiani, MD

Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, CA United States

Caroline Behler, MD

Pacific Hematology Oncology Associates
San Francisco, CA United States

Visha Rana, MD

University of Colorado Health Memorial Hospital
Colorado Springs, CO United States

Steven Schuster, MD

Poudre Valley Hospital Harmony Campus
Fort Collins, CO United States

Bradley Sumrall, MD

Central Georgia Cancer Care
Macon, GA United States

Scott Smith, MD

Loyola University Medical Center
Maywood, IL United States

Umar Farooq, MD

University of Iowa Hospitals and Clinics
Iowa City, IA United States

Don Stevens, MD

Norton Cancer Institute
Louisville, KY United States

Muhammed-Ali Zaydan, MD

Montgomery Cancer Center
Mount Sterling, KY United States

Nakhle Saba, MD

Tulane University Hospital and Clinic
New Orleans, LA United States

Sumana Devata, MD

University of Michigan Comprehensive Cancer Center
Ann Arbor, MI United States

Michaela Tsai, MD

Virginia Piper Cancer Institute
Minneapolis, MN United States

John Hrom, MD

Hattiesburg Clinic (Forrest General Hospital)
Hattiesburg, MS United States

Suman Kambhampati, MD

Research Medical Center
Kansas City, MO United States

Sadar Imam, MD

San Juan Oncology Associates
Farmington, NM United States

Joshua Brody, MD

Mount Sinai Hospital
New York, NY United States

Murali Janakiram, MD

Montefiore Medical Center - Bronx
The Bronx, NY United States

Matthew McKinney, MD

Duke University Medical Center
Durham, NC United States

Keith Lerro, MD

Regional Medical Oncology Center
Wilson, NC United States

Nashat Gabrail, MD

Gabrail Cancer Center Research
Canton, OH United States

Paolo Caimi, MD

University Hospitals Seidman Cancer Center
Cleveland, OH United States

Onder Alpdogan, MD

Thomas Jefferson University Hospital
Philadelphia, PA United States

Jing-Zhou Hou, MD

University of Pittsburgh Medical Center
Pittsburgh, PA United States

Valeriy Sedov, MD

Hollings Cancer Center
Charleston, SC United States

Ian Flinn, MD

Tennessee Oncology / Sarah Cannon Research Institute
Nashville, TN United States

Moshe Yair Levy, MD

Baylor Health - Baylor University Medical Center
Dallas, TX United States

Donald Quick, MD

Joe Arrington Cancer Research and Treatment Center
Lubbock, TX United States

Vinit Karur, MD

Scott and White Memorial Hospital - Temple
Temple, TX United States

Ying Zhou, MD

Kadlec Clinic Hematology and Oncology
Kennewick, WA United States

Joseph Ye, MD

Vista Oncology INC PS
Olympia, WA United States

Jorge Chaves, MD

Northwest Medical Specialties, PLLC
Tacoma, WA United States

Anna DiMarco, MD

Ponce Medical School Foundation
Ponce, Puerto Rico