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

Mantle Cell Lymphoma Clinical Trial

— CITADEL-310  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04849715
• Other study ID #: INCB 50465-310
• Status: Withdrawn
• Phase: Phase 3
• Start date: March 11, 2022
• Est. completion date: July 7, 2034

Study information

• Verified date: April 2022
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 7, 2034
• Est. primary completion date: August 15, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	Defined as the time from the date of randomization until the date of first-documented disease progression, as determined by an Independent Review Committee (IRC) based on the Lugano criteria, or death from any cause, whichever happens first.	7 years
Secondary	Overall Survival	Defined as the time from the date of randomization until death from any cause.	10 years
Secondary	Objective Response Rate	Defined as the proportion of participants with a Complete Response (CR) or Partial Response (PR) as determined by an IRC- provided radiographic disease assessment of response according to response criteria for lymphomas.	7 Years
Secondary	Complete Response Rate	Defined as the proportion of participants with a CR as determined by an IRC- provided radiographic disease assessment of response according to response criteria for lymphomas.	7 Years
Secondary	Duration of Response	Defined as the time from first-documented evidence of CR or PR until first documented disease progression or death from any cause, whichever happens first, among participants who achieve an objective response, as determined by radiographic disease assessment provided by an IRC.	7 Years
Secondary	Duration Of Complete Response	Defined as the time from the first evidence of CR to the date of first documented disease progression or death from any cause, whichever happens first, among participants who achieve a CR, as determined by radiographic disease assessment provided by an IRC.	7 Years
Secondary	Disease Control Rate	Defined as the proportion of participants who achieved a response of CR, PR, or Stable Disease (SD) assessed by an IRC.	7 Years
Secondary	Event Free Survival	Defined as the time from date of randomization to date of first documented progression, as determined by radiographic disease assessment provided by an IRC, administration of a new anti lymphoma treatment, or death from any cause, whichever happens first.	7 Years
Secondary	Time To Next anti-Lymphoma Treatment	Defined as the time from date of randomization to date of first documented administration of a new anti-lymphoma treatment.	7 Years
Secondary	Progression-Free Survival on next anti-lymphoma treatment	Defined as the time from the date of randomization to the date of first documented disease progression as reported by investigator after next anti-lymphoma treatment or death from any cause, or start of a third anti-lymphoma treatment since randomization, whichever happens first.	7 Years
Secondary	Treatment Emergent Adverse Events	Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study drug/treatment.	7 Years