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
Haddasah Medical Center ( Site 0601)
Jerusalem, 9112001
IsraelActive - Recruiting
Sheba Medical Center ( Site 0603)
Ramat Gan, 5265601
IsraelActive - Recruiting
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