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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diffuse Large B-Cell Lymphoma

In brief

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).

Key facts

Study ID: NCT03274492
Run by: Hoffmann-La Roche
People needed: 1000
Starts: 2017-11-16
Expected to finish: 2026-04-30
Last updated by the study team: 2026-05-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and refrain from donating eggs.
Male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agreement to refrain from donating sperm.

You may not qualify if…

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

Where it is running

Southern Cancer Center — Daphne, Alabama, United States
City of Hope — Duarte, California, United States
Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
Rocky Mountain Cancer Centers, LLP — Aurora, Colorado, United States
Georgetown University Medical Center — Washington D.C., District of Columbia, United States
Florida Cancer Specialists - Fort Myers (New Hampshire Ct) — Fort Myers, Florida, United States
Florida Cancer Specialists & Research Institute — St. Petersburg, Florida, United States
Florida Cancer Specialists & Research Institute — St. Petersburg, Florida, United States
Emory University — Atlanta, Georgia, United States
Illinois Cancer Specialists — Arlington Heights, Illinois, United States
James Graham Brown Cancer Center — Louisville, Kentucky, United States
Ochsner Medical Center — New Orleans, Louisiana, United States
University of Maryland — Baltimore, Maryland, United States
The Johns Hopkins Hospital — Baltimore, Maryland, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Dana Farber Cancer Institute — Boston, Massachusetts, United States
University of Michigan Health System — Ann Arbor, Michigan, United States
Karmanos Cancer Center — Detroit, Michigan, United States
Washington University — St Louis, Missouri, United States
Roswell Park Cancer Institute — Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center at Westchester — Harrison, New York, United States
New York University Cancer Cen — New York, New York, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Memorial Sloan Kettering Cancer Center - Commack — New York, New York, United States
University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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