NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT03274492

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Diffuse Large B-Cell Lymphoma

Interventions: Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine

Countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Czechia

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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
* 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.

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

Locations (209)

Birmingham, Alabama, United States
Daphne, Alabama, United States
Duarte, California, United States
Los Angeles, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Fort Myers, Florida, United States
St. Petersburg, Florida, United States
St. Petersburg, Florida, United States
Atlanta, Georgia, United States
Arlington Heights, Illinois, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
St Louis, Missouri, United States
Buffalo, New York, United States
Harrison, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
+ 179 more on CT.gov