Status:
WITHDRAWN
A Study of Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma
Lead Sponsor:
Incyte Corporation
Conditions:
Mantle Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2034
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04849715
Start Date
March 11 2022
End Date
July 7 2034
Last Update
April 29 2022
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