A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 80
Updated:3/23/2019
Start Date:November 16, 2017
End Date:April 15, 2023
Contact:Reference Study ID Number: GO39942 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination With Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma

This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy,
safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants
with previously untreated diffuse large B-cell lymphoma (DLBCL).


Inclusion Criteria:

- Previously untreated participants with cluster of differentiation 20 (CD20)-positive
DLBCL, including one of the following diagnoses by 2016 World Health Organization
(WHO) classification of lymphoid neoplasms: DLBCL, not otherwise specified (NOS)
including germinal center B-cell type, activated B-cell type; T-cell/histiocyte-rich
large B-cell lymphoma; Epstein-Barr virus-positive DLBCL, NOS; anaplastic lymphoma
kinase (ALK)-positive large B-cell lymphoma; human herpesvirus-8 (HHV8)-positive
DLBCL, NOS; High-grade B-cell lymphoma with MYC and B-cell lymphoma 2 (BCL2) and/or
B-cell lymphoma 6 (BCL6) rearrangements (double-hit or triple-hit lymphoma);
High-grade B-cell lymphoma, NOS

- Availability of archival or freshly collected tumor tissue before study enrolment

- International Prognostic Index (IPI) score of 2-5

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

- Life expectancy greater than or equal to (>/=)12 months

- Left ventricular ejection fraction (LVEF) >/= 50 percent (%) on cardiac multiple-gated
acquisition (MUGA) scan or cardiac echocardiogram (ECHO)

- Adequate hematologic function

Exclusion Criteria:

- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies or known sensitivity or allergy to murine products

- Contraindication to any of the individual components of CHOP, including prior receipt
of anthracyclines

- Prior organ transplantation

- Current Grade greater than (>) 1 peripheral neuropathy by clinical examination

- Demyelinating form of Charcot-Marie-Tooth disease

- History of indolent lymphoma

- History of follicular lymphoma grade 3B

- B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and
classical Hodgkin lymphoma (grey-zone lymphoma)

- Primary mediastinal (thymic) large B-cell lymphoma

- Burkitt lymphoma

- Prior treatment with cytotoxic drugs within 5 years of screening for any condition
(example [e.g.], cancer, rheumatoid arthritis) or prior use of any anti-CD20 antibody

- Prior use of any monoclonal antibody within 3 months of the start of Cycle 1

- Prior therapy for DLBCL, with the exception of nodal biopsy

- Corticosteroid use >30 mg/day of prednisone or equivalent, for purposes other than
lymphoma symptom control

- Participants with central nervous system (CNS) lymphoma (primary or secondary
involvement), primary effusion DLBCL, and primary cutaneous DLBCL

- Vaccination with live vaccines within 28 days prior to the start of Cycle 1

- Any investigational therapy within 28 days prior to the start of Cycle 1

- History of other malignancy that could affect compliance with the protocol or
interpretation of results

- Evidence of significant, uncontrolled, concomitant diseases that could affect
compliance with the protocol or interpretation of results, including significant
cardiovascular disease or pulmonary disease

- Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for
diagnosis

- History or presence of an abnormal electrocardiogram (ECG) that is clinically
significant in the investigator's opinion, including complete left bundle branch
block, second- or third-degree heart block, or evidence of prior myocardial infarction

- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
(excluding fungal infections of nail beds) at study enrollment or significant
infections within 2 weeks before the start of Cycle 1

- Clinically significant liver disease, including active viral or other hepatitis,
current alcohol abuse, or cirrhosis

- Prior radiotherapy to the mediastinal/pericardial region

- Participants with suspected active or latent tuberculosis

- Positive test results for chronic hepatitis B and hepatitis C infection

- Known history of human immunodeficiency virus (HIV) seropositive status

- Positive results for the human T-lymphotrophic 1 virus (HTLV-1)

- Participants with a history of progressive multifocal leukoencephalopathy
We found this trial at
55
sites
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Arlington Heights, Illinois 60005
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Austin, Texas 78705
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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450 Brookline Avenue
Boston, Massachusetts 02115
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Charleston, South Carolina 29403
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2200 East 3rd Street
Chattanooga, Tennessee 37404
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320 West 10th Avenue
Columbus, Ohio 43210
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650 Commack Rd
Commack, New York 11725
(631) 623-4000
Memorial Sloan-Kettering Cancer Center at Commack Memorial Sloan Kettering Cancer Center - the world's oldest...
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Concord, New South Wales
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Daphne, Alabama 36526
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Detroit, Michigan 48202
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Duarte, California 91010
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Eugene, Oregon 97401
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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3050 Mack Road
Fairfield, Ohio 45014
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15681 New Hampshire Court
Fort Myers, Florida 33901
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Greenville, South Carolina 29605
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500 Westchester Avenue
Harrison, New York 10604
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7415 Las Colinas Boulevard
Irving, Texas 75063
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Irving, Texas 75063
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Kansas City, Missouri 64132
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601 South Floyd Street
Louisville, Kentucky 40202
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225 Summit Avenue
Montvale, New Jersey 07645
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1 Medical Center Dr # 1000
Morgantown, West Virginia 26506
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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160 East 34th Street
New York, New York 10016
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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333 Cottman Avenue
Philadelphia, Pennsylvania 19111
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
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660 South Euclid Avenue
Saint Louis, Missouri 63110
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Saint Petersburg, Florida 33705
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825 Eastlake Avenue East
Seattle, Washington 98101
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West Palm Beach, Florida 33401
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Winchester, Virginia 22601
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808 North 39th Avenue
Yakima, Washington 98902
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