Clinical trial NCT04849715: A Study of Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Mantle Cell Lymphoma
Keywords: parsaclisib
newly diagnosed
bendamuastine
rituximab
PI3Kδ
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2021-04-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: 7 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 10 years
measure: Objective Response Rate
timeFrame: 7 Years
measure: Complete Response Rate
timeFrame: 7 Years
measure: Duration of Response
timeFrame: 7 Years
measure: Duration Of Complete Response
timeFrame: 7 Years
measure: Disease Control Rate
timeFrame: 7 Years
measure: Event Free Survival
timeFrame: 7 Years
measure: Time To Next anti-Lymphoma Treatment
timeFrame: 7 Years
measure: Progression-Free Survival on next anti-lymphoma treatment
timeFrame: 7 Years
measure: Treatment Emergent Adverse Events
timeFrame: 7 Years
Other outcomes:
Locations:
Study officials:
References: