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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) | Clinical Trials | Clareo Health

WITHDRAWNPHASE3

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)

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Parsaclisib Plus Investigator's Choice of Either Rituximab or Obinutuzumab in Participants With Relapsed or Refractory Follicular Lymphoma and Marginal Zone Lymphoma

NCT04796922•Incyte Corporation

View on ClinicalTrials.gov

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) .

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
•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.

Exclusion Criteria

•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.

Key Dates

Start Date

December 30, 2022

Primary Completion Date

December 20, 2028

Completion Date

August 25, 2032

Last Updated

July 18, 2022

Conditions

Follicular Lymphoma ( FL)Marginal Zone Lymphoma (MZL)

Interventions

parsaclisib

DRUG

rituximab

DRUG

obinutuzumab

DRUG

Orelabrutinib as Consolidation and Maintenance Therapy in Treatment-Naïve MZL.

NCT07372365

Marginal Zone Lymphoma (MZL)

View study

RECRUITING

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

NCT06043011

Chronic Lymphocytic Leukemia (CLL)Diffuse Large B-cell Lymphoma (DLBCL)+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

Orelabrutinib as Consolidation and Maintenance Therapy in Treatment-Naïve MZL.

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

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Therapy of Non-Hodgkin-Lymphoma by Combination of Lenalidomide + Rituximab, Dexa, High-dose ARA-C and CisP