Loading clinical trials...

INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)

A Phase 1, Open-Label, Dose-Finding Study of INCB050465 in Combination With Investigator Choice of Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)

NCT03424122•Incyte Corporation

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and tolerability of parsaclisib when combined with rituximab, bendamustine and rituximab, or ibrutinib in participants with relapsed or refractory B-cell lymphoma.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men and women, aged 18 years or older on the day of signing the Informed Consent Form (ICF).
•Histologically confirmed indolent/aggressive DLBCL, FL, MZL, or MCL.
•Participants with DLBCL, MZL or MCL must have received at least 1 prior line of systemic therapy with documented progression or documented failure to achieve CR or PR after the most recent systemic treatment regimen.
•Participants with FL must have received at least 2 prior lines of systemic therapy with documented progression or documented failure to achieve CR or PR after the most recent systemic treatment regimen.
•Ineligible for stem cell transplant.
•Participants with DLBCL must have failed or refused stem cell transplantation or failed first-line salvage therapy if ineligible for transplantation.
•Must be willing to undergo an incisional or excisional lymph node or tissue biopsy or to provide a lymph node or tissue biopsy from the most recent available archival tissue.
•Life expectancy of \> 3 months.
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 (see Appendix D).
•Willingness to avoid pregnancy or fathering a child.
+8 more criteria

Exclusion Criteria

•Evidence of transformed non-Hodgkin lymphoma histologies (with the exception of FL).
•Histologically confirmed rare non-Hodgkin B-cell subtypes.
•History of or central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
•Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.

Locations (21)

University of Arizona Cancer Center - Out Pt.

Tucson, Arizona, United States

Indiana Blood and Marrow Transplantation

Indianapolis, Indiana, United States

Comprehensive Cancer Center of Nevada

Las Vegas, Nevada, United States

Texas Oncology

Austin, Texas, United States

Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Smith Clinic

Houston, Texas, United States

Cancer Care Centers of South Texas

San Antonio, Texas, United States

Texas Oncology San Antonio

San Antonio, Texas, United States

Asst Spedali Civili Di Brescia

Brescia, Italy

Key Dates

Start Date

July 2, 2018

Primary Completion Date

June 27, 2022

Completion Date

June 27, 2022

Last Updated

August 21, 2025

Enrollment

ACTUAL participants

Conditions

B-cell Lymphoma

Interventions

Parsaclisib

DRUG

Rituximab

DRUG

Bendamustine

DRUG

Ibrutinib

DRUG

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

NCT05139017

DLBCLDiffuse Large B-Cell Lymphoma

View study

RECRUITINGPHASE1

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

NCT06026319

Non-hodgkin LymphomaRelapsed Non-Hodgkin Lymphoma+8 more

View study

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: August 21, 2025Data 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.

View ClinicalTrials.gov Terms and Conditions

INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)

Inclusion Criteria

Exclusion Criteria

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

A Long-term Extension Study of PCI-32765 (Ibrutinib)

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma

Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma