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

NCT04849715 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: INCB 50465-310
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mantle Cell Lymphoma

Keywords

parsaclisib; newly diagnosed; bendamuastine; rituximab; PI3Kδ

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Overall Survival

  10 years

• Objective Response Rate

  7 Years

• Complete Response Rate

  7 Years

• Duration of Response

  7 Years

• Duration Of Complete Response

  7 Years

Study Arms (2)

Treatment Group A

ACTIVE COMPARATOR

Participants will be administered parsaclisib once daily and will receive Bendamustine and Rituximab periodically for 6 months.

Drug: parsaclisib; Drug: rituximab; Drug: bendamustine

Treatment group B

PLACEBO COMPARATOR

Participants will be administered placebo once daily and will receive Bendamustine and Rituximab periodically for 6 months.

Drug: rituximab; Drug: bendamustine; Drug: Placebo

Interventions

parsaclisib DRUG

parsaclisib will be administered orally once daily.

Also known as: INCB050465

Treatment Group A

rituximab DRUG

rituximab is administered IV on Day 1 of each 28-day cycle for 6 cycles.

Also known as: Rituxan

Treatment Group A; Treatment group B

bendamustine DRUG

bendamustine is administered IV on Day 1 and 2 of each 28-day cycle for 6 cycles.

Also known as: Bendeka, Treanda

Treatment Group A; Treatment group B

Placebo DRUG

placebo will be administered orally once daily

Treatment group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

parsaclisib; Rituximab; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 19, 2021
• Study Start: March 11, 2022
• Primary Completion (Estimated): August 15, 2030
• Study Completion (Estimated): July 7, 2034
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.