Study Detail

CRITERIA

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion:

• Has histologically confirmed diagnosis of DLBCL by prior biopsy
• Has positron emission tomography (PET)-positive disease verified by blinded independent central review (BICR) at screening, defined as 4-5 on the Lugano response criteria 5-point scale
• Has received no prior treatment for DLBCL
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days prior to the start of study intervention

Exclusion:

• Has a history of transformation of indolent disease to DLBCL
• Has received solid organ transplant at any time
• Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL)
• Has clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication
• Has pericardial effusion or clinically significant pleural effusion
• Has ongoing Grade >1 peripheral neuropathy
• Has a demyelinating form of Charcot-Marie-Tooth disease
• History of a second malignancy unless potentially curative treatment has been completed with no evidence of malignancy for 2 years with the exception of participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous-cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder
• Has received prior radiotherapy within 28 days of start of study intervention
• Has ongoing corticosteroid therapy (exceeding 30 mg daily of prednisone equivalent)
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
• Has received a strong inhibitor or inducer of CYP3A4 (including itraconazole, ketoconazole, posaconazole, or voriconazole) within 7 days prior to the start of study intervention or expected requirement for chronic use of a strong CYP3A4 inhibitor until <30 days after the last dose
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study intervention
• Has known active central nervous system (CNS) lymphoma
• Has an active infection requiring systemic therapy
• Has a known history of human immunodeficiency virus (HIV) infection
• Has a known active hepatitis C virus infection
• Has a known active hepatitis B virus infection