A Study of Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma

A Phase 3, Randomized, Double-Blind Study Comparing Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab (BR), With Placebo and BR for the Treatment of Newly Diagnosed Mantle Cell Lymphoma

This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study of parsaclisib plus BR versus placebo plus BR as first-line treatment of participants with newly diagnosed MCL.

Inclusion Criteria:

• Male and female participants aged 18 years or older. (Japan aged 20 years or older.)
• Have received no previous systemic anti-lymphoma therapies.
• Pathologically confirmed MCL by local laboratory.
• Histologically confirmed CD20 expression (by flow cytometry or immunohistochemistry) of the MCL cells as assessed by pathology.
• Ineligible for high-dose chemotherapy and autologous stem cell transplantation.
• Radiographically (CT, MRI) measurable lymphadenopathy per the Lugano criteria for response assessment (Cheson et al 2014).
• ECOG PS of 0 to 2.
• Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

• Presence of any lymphoma other than MCL.
• Presence of CNS lymphoma (either primary or secondary) or leptomeningeal disease.
• Requires treatment with potent inducers and inhibitors of CYP3A4
• Inadequate organ functions including hematopoiesis, liver, and kidney significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, GI, endocrine, pulmonary, neurological, cerebral, or psychiatric disease.
• History of other malignancy within 2 years of study entry.
• Known HIV infection, HBV or HCV.
• HBV or HCV infection: Participants positive for HBsAg or anti-HBc will be eligible if they are negative for HBV-DNA; these participants must receive prophylactic antiviral therapy. Participant's positive for HCV antibody will be eligible if they are negative for HCV-RNA.
• Clinically significant cardiac disease, congestive heart failure, including unstable angina, acute myocardial infarction, or cardiac conduction issues, within 6 months of randomization.
• Abnormal ECG findings that are clinically meaningful per investigator's assessment.
• Women who are pregnant or breastfeeding
• Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.