Phase
Condition
Lymphoma
Treatment
Rituximab Biosimilar
Cyclophosphamide
Doxorubicin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Has histologically confirmed diagnosis of germinal center B-cell (GCB) subtype ofdiffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the WorldHealth Organization (WHO) classification of neoplasms of the hematopoietic andlymphoid tissues.
Has positron emission tomography (PET) positive disease at screening, defined as 4to 5 on the Lugano 5-point scale.
Has received no prior treatment for their DLBCL.
Human immunodeficiency virus (HIV) infected participants must have well controlledHIV on antiretroviral therapy (ART).
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible ifthey have received hepatitis B virus (HBV) antiviral therapy and have undetectableHBV viral load prior to randomization.
Participants with history of hepatitis C virus (HCV) infection are eligible if HCVviral load is undetectable at screening.
Exclusion
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Has a history of transformation of indolent disease to DLBCL.
Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zonelymphoma.
Has Ann Arbor Stage I DLBCL.
Has clinically significant (i.e., active) cardiovascular disease: cerebral vascularaccident/stroke (<6 months prior to enrollment), myocardial infarction (<6 monthsprior to enrollment), unstable angina, congestive heart failure (New York HeartAssociation Classification Class ≥II), or serious cardiac arrhythmia requiringmedication.
Has clinically significant pericardial or pleural effusion.
Has ongoing Grade >1 peripheral neuropathy.
Has a demyelinating form of Charcot-Marie-Tooth disease.
HIV-infected participants with a history of Kaposi's sarcoma and/or MulticentricCastleman's Disease.
Has ongoing corticosteroid therapy.
Known additional malignancy that is progressing or has required active treatmentwithin the past 2 years.
Known active central nervous system (CNS) lymphoma.
Has active autoimmune disease that has required systemic treatment in the past 2years.
Has active infection requiring systemic therapy.
Has active HBV (defined as HBsAg positive and detectable HBV deoxyribonucleic acid (DNA)) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleicacid (RNA)) infection.
Has history of stem cell/solid organ transplant.
Study Design
Connect with a study center
Hopital de Jolimont ( Site 0304)
Haine Saint Paul, Hainaut 7100
BelgiumActive - Recruiting
UZ Leuven ( Site 0301)
Leuven, Vlaams-Brabant 3000
BelgiumActive - Recruiting
Universitaetsklinikum Wuerzburg ( Site 0401)
Wuerzburg, Bayern 97080
GermanyActive - Recruiting
Rambam Health Care Campus ( Site 0604)
Haifa, 3109601
IsraelActive - Recruiting
Haddasah Medical Center ( Site 0601)
Jerusalem, 9112001
IsraelActive - Recruiting
Sheba Medical Center ( Site 0603)
Ramat Gan, 5265601
IsraelActive - Recruiting
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0707)
Meldola, Forli-Cesena 47014
ItalyActive - Recruiting
Istituto Clinico Humanitas ( Site 0704)
Rozzano, Milano 20089
ItalyActive - Recruiting
Istituto Europeo di Oncologia ( Site 0701)
Milano, 20141
ItalyActive - Recruiting
Universita degli Studi di Napoli Federico II ( Site 0705)
Napoli, 80131
ItalyActive - Recruiting
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO ( Site 0702)
Palermo, 90146
ItalyActive - Recruiting
Arcispedale Santa Maria Nuova ( Site 0706)
Reggio Emilia, 42123
ItalyActive - Recruiting
National Hospital Organization Sendai Medical Center ( Site 1005)
Sendai, Miyagi 983-8520
JapanActive - Recruiting
Shimane University Hospital ( Site 1002)
Izumo, Shimane 693-8501
JapanActive - Recruiting
Nippon Medical School Hospital ( Site 1001)
Bunkyo, Tokyo 113-8603
JapanActive - Recruiting
Pratia MCM Krakow ( Site 0804)
Karkow, Malopolskie 30-727
PolandActive - Recruiting
Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu ( Site 0806)
Nowy Sącz, Malopolskie 33-300
PolandActive - Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0803)
Warszawa, Mazowieckie 02-781
PolandActive - Recruiting
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