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



Status:Terminated
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Start Date:August 2016
End Date:May 15, 2018

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Trial Summary
Trial Overview
Inclusion Criteria

An Open Label Phase 2 Study of Denintuzumab Mafodotin (SGN-CD19A) in Combination With RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) or RCHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone) Compared With RCHOP Alone as Frontline Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) Grade 3b

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.

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).

Inclusion Criteria:

- Treatment-naive patients with histologically confirmed systemic de novo or transformed
diffuse large B-cell lymphoma (DLBCL) (from follicular or marginal zone lymphoma), or
follicular lymphoma (FL) Grade 3b;

- patients must have high intermediate or high risk disease

- Tumor tissue available from most recent biopsy to determine cell of origin

- Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease
greater than 1.5cm diameter

- Eastern Cooperative Oncology Group performance status ≤2

- Age 18 years or older

- Adequate study baseline laboratory parameters

Exclusion Criteria:

- Previous history of treated indolent lymphoma

- History of another primary invasive cancer, hematologic malignancy, or myelodysplastic
syndrome that has not been in remission for at least 3 years

- History of progressive multifocal leukoencephalopathy

- Cerebral/meningeal disease related to the underlying malignancy

- Patients with the following ocular conditions: corneal disorders, monocular vision
(ie. best corrected visual acuity greater than or equal to 20/200 in one eye), or
active ocular disorders requiring treatment
We found this trial at
35
sites
University of Michigan Comprehensive Cancer Center
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
Principal Investigator: Sumana Devata, MD
Phone: 734-232-0773
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Amitkumar Mehta, MD
Phone: 205-975-2076
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Montefiore Medical Center - Bronx
Bronx, New York 10467
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Bronx, NY
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Gabrail Cancer Center Research LLC
Canton, Ohio 44718
Principal Investigator: Nashat Gabrail, MD
Phone: 330-492-3345
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Canton, OH
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Hollings Cancer Center
Charleston, South Carolina 29425
Principal Investigator: Valeriy Sedov, MD
Phone: 843-792-8856
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Charleston, SC
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University Hospitals Seidman Cancer Center
Cleveland, Ohio 44106
Principal Investigator: Paolo Caimi, MD
Phone: 216-983-0771
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Cleveland, OH
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University of Colorado Health Memorial Hospital
1400 East Boulder Street
Colorado Springs, Colorado 80909
Principal Investigator: Visha Rana, MD
Phone: 719-365-9645
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Colorado Springs, CO
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Baylor Health - Baylor University Medical Center
Dallas, Texas 75226
Principal Investigator: Moshe Yair Levy, MD
Phone: 214-818-8472
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City of Hope
Duarte, California 91010
Principal Investigator: Elizabeth Budde, MD
Phone: 626-218-0563
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Duarte, CA
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Duke Univ Med Ctr
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Matthew McKinney, MD
Phone: 919-668-4769
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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San Juan Oncology Associates
Farmington, New Mexico 87401
Principal Investigator: Sadar Imam, MD
Phone: 505-564-6874
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Poudre Valley Hospital Harmony Campus
2127 East Harmony Road
Fort Collins, Colorado 80528
Principal Investigator: Steven Schuster, MD
Phone: 970-297-6150
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Compassionate Cancer Care Medical Group, Inc
Fountain Valley, California 92708
Principal Investigator: Haresh Jhangiani, MD
Phone: 714-698-0300
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Hattiesburg Clinic (Forrest General Hospital)
301 South 28th Avenue
Hattiesburg, Mississippi 39401
Principal Investigator: John Hrom, MD
Phone: 601-261-1700
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University of Iowa Hospitals and Clinics
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Umar Farooq, MD
Phone: 319-353-8914
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Saint Bernards Cancer Center
405 East Jackson Avenue
Jonesboro, Arkansas 72401
Principal Investigator: Marc Monte, MD
Phone: 870-207-8177
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Jonesboro, AR
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Research Medical Center
2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
Principal Investigator: Suman Kambhampati, MD
Phone: 816-276-9786
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
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Kadlec Clinic Hematology and Oncology
Kennewick, Washington 99336
Principal Investigator: Ying Zhou, MD
Phone: 509-783-4637
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Norton Cancer Institute
Louisville, Kentucky 40207
Principal Investigator: Don Stevens, MD
Phone: 502-899-3366
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Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas 79410
Principal Investigator: Donald Quick, MD
Phone: 806-725-8068
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Central Georgia Cancer Care
Macon, Georgia 31201
Principal Investigator: Bradley Sumrall, MD
Phone: 478-743-7068
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Loyola University Medical Center
2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Scott Smith, MD
Phone: 708-327-3228
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Virginia Piper Cancer Institute
Minneapolis, Minnesota 55408
Principal Investigator: Michaela Tsai, MD
Phone: 612-863-9466
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Minneapolis, MN
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Montgomery Cancer Center
Mount Sterling, Kentucky 40353
Principal Investigator: Muhammed-Ali Zaydan, MD
Phone: 859-499-1000
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Tennessee Oncology / Sarah Cannon Research Institute
Nashville, Tennessee 37203
Principal Investigator: Ian Flinn, MD
Phone: 615-329-7236
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Tulane University Hospital & Clinic
New Orleans, Louisiana 70112
Principal Investigator: Nakhle Saba, MD
Phone: 504-988-6311
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New Orleans, LA
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Mount Sinai Hosp
New York, New York 10029
Principal Investigator: Joshua Brody, MD
Phone: 212-824-7822
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New York, NY
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Vista Oncology Inc. PS
Olympia, Washington 98502
Principal Investigator: Joseph Ye, MD
Phone: 360-352-2900
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Olympia, WA
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Thomas Jefferson University Hospital
111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Onder Alpdogan, MD
Phone: 215-955-5769
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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University of Pittsburgh Medical Center
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Jing-Zhou Hou, MD
Phone: 412-647-8571
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Ponce Medical School Foundation
388 Zona Ind Reparada 2
Ponce, 00716
Principal Investigator: Anna DiMarco, MD
Phone: (787) 840-2575
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Pacific Hematology Oncology Associates
San Francisco, California 94115
Principal Investigator: Caroline Behler, MD
Phone: 415-600-5766
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Northwest Medical Specialties
Tacoma, Washington 98405
Principal Investigator: Jorge Chaves, MD
Phone: 253-428-8752
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Tacoma, WA
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Scott and White Memorial Hospital - Temple
2401 South 31st Street
Temple, Texas 76508
Principal Investigator: Vinit Karur, MD
Phone: 254-724-1291
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Regional Medical Oncology Center
2624 Ortho Drive
Wilson, North Carolina 27893
Principal Investigator: Keith Lerro, MD
Phone: 252-991-5261
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