A Study of Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma
NCT ID: NCT04849715
Last Updated: 2022-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2022-03-11
2034-07-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment Group A
Participants will be administered parsaclisib once daily and will receive Bendamustine and Rituximab periodically for 6 months.
parsaclisib
parsaclisib will be administered orally once daily.
rituximab
rituximab is administered IV on Day 1 of each 28-day cycle for 6 cycles.
bendamustine
bendamustine is administered IV on Day 1 and 2 of each 28-day cycle for 6 cycles.
Treatment group B
Participants will be administered placebo once daily and will receive Bendamustine and Rituximab periodically for 6 months.
rituximab
rituximab is administered IV on Day 1 of each 28-day cycle for 6 cycles.
bendamustine
bendamustine is administered IV on Day 1 and 2 of each 28-day cycle for 6 cycles.
Placebo
placebo will be administered orally once daily
Interventions
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parsaclisib
parsaclisib will be administered orally once daily.
rituximab
rituximab is administered IV on Day 1 of each 28-day cycle for 6 cycles.
bendamustine
bendamustine is administered IV on Day 1 and 2 of each 28-day cycle for 6 cycles.
Placebo
placebo will be administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Other Identifiers
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INCB 50465-310
Identifier Type: -
Identifier Source: org_study_id
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