To Evaluate Efficacy and Safety of Parsaclisib Plus Either Rituximab or Obinutuzumab in R/R Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) (CITADEL-302)

NCT04796922 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: INCB 50465-302
• 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 investigator's choice of either rituximab or obinutuzumab versus placebo plus investigator's choice of rituximab or obinutuzumab for the treatment of participants with R/R FL or MZL. The Participants will be stratified in a 1:1 randomization ratio by investigator's choice of rituximab or obinutuzumab prior to randomization, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (MZL or FL) .

Conditions

Follicular Lymphoma ( FL); Marginal Zone Lymphoma (MZL)

Keywords

parsaclisib; Relapsed/Refractory; obinutuzumab; rituximab

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) in R/R FL and MZL participants

  Defined as the time from the date of randomization until the first documented disease progression as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014) or death from any cause, whichever occurs first.

  62 months

Secondary Outcomes (11)

• Progression Free Survival (PFS) in R/R FL participants

  62 months

• Overall Response Rate (ORR)

  62 months

• Overall Survival (OS)

  10 years

• Progression Free Survival (PFS) in R/R MZL participants

  62 months

• Complete Response Rate (CRR)

  62 months

Study Arms (2)

Treatment Group A

EXPERIMENTAL

Participants will be administered with parsaclisib in combination with investigator choice of rituximab or obinutuzumab.

Drug: parsaclisib; Drug: rituximab; Drug: obinutuzumab

Treatment Group B

PLACEBO COMPARATOR

Participants will be administered with placebo in combination with investigator choice of rituximab or obinutuzumab

Drug: rituximab; Drug: obinutuzumab

Interventions

parsaclisib DRUG

parsaclisib will be administered once daily at 20 mg for 8 weeks followed by 2.5 mg once daily.

Also known as: INCB050465

Treatment Group A

rituximab DRUG

rituximab will be administered intravenously on select days as per protocol.

Treatment Group A; Treatment Group B

obinutuzumab DRUG

obinutuzumab will be administered intravenously on select days as per protocol.

Treatment Group A; 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).
• Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL
• Prior systemic treatment with at least 1 anti-CD20 mAb (either as monotherapy or in combination as chemoimmunotherapy)
• Documented disease that has relapsed or progressed or was refractory after the most recent prior systemic therapy. Note: Participants must not be refractory to anti-CD20 mAb
• Radiographically (CT, MRI) measurable lymphadenopathy per the Lugano criteria for response assessment (Cheson et al 2014).
• ECOG PS of 0 to 2
• Adequate organ functions including hematopoiesis, liver, and kidney
• Willingness to avoid pregnancy or fathering children

You may not qualify if:

• Women who are pregnant or breastfeeding.
• Known histological transformation from indolent NHL to an aggressive NHL (eg, diffuse large B-cell lymphoma).
• Presence of CNS lymphoma (either primary or secondary) or leptomeningeal disease.
• Prior treatment with PI3K inhibitors.
• Inadequate washout of immunosuppressive therapy, anticancer medications and investigational drugs.
• Significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, GI, endocrine, pulmonary, neurological, cerebral, cardiac, infectious, or psychiatric disease.
• Known HIV infection.
• 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. Participants positive for HCV antibody will be eligible if they are negative for HCV-RNA.
• History of other malignancy within 2 years of study entry.
• Any condition that would, in the investigator's judgment, interfere with full participation in the study.

Sponsors & Collaborators

• Incyte Corporation: lead

MeSH Terms

Conditions

Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Recurrence

Interventions

parsaclisib; Rituximab; obinutuzumab

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; Lymphoma, B-Cell; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 15, 2021
• Study Start: December 30, 2022
• Primary Completion (Estimated): December 20, 2028
• Study Completion (Estimated): August 25, 2032
• Last Updated: July 18, 2022

Record last verified: 2022-07

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.