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

• Status: Not yet recruiting
• Trial end date: 2031-10-27
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Bendamustine Hydrochloride; Rituximab

Criteria

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.