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

August 19, 2025 updated by: Incyte Corporation

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25123
        • ASST Spedali Civili di Brescia
      • Monza, Italy, 20835
        • Azienda Ospedaliera San Gerardo di Monza
      • Pisa, Italy, 56126
        • Azienda Ospedaliera Universitaria Pisana
      • Ravenna, Italy, 48121
        • Ospedale Delle Croci - Ematologia Ravenna
  • Spain
      • Badalona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial
      • Barcelona, Spain, 08035
        • Hospital General Universitari Vall d Hebron
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz University Hospital
      • Madrid, Spain, 28050
        • Hospital Universitario Hm Sanchinarro
      • Salamanca, Spain, 37007
        • Hospital Clinico Universitario de Salamanca
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocío
      • Valencia, Spain, 46026
        • Hospital Universitario Y Politecnic La Fe
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • University of Arizona Cancer Center - Out Pt.
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Indiana Blood and Marrow Transplantation
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Center of Nevada
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Oncology
      • Dallas, Texas, United States, 75246
        • Baylor Charles A. Sammons Cancer Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77054
        • Smith Clinic
      • San Antonio, Texas, United States, 78240
        • Texas Oncology San Antonio
      • San Antonio, Texas, United States, 78217
        • Cancer Care Centers of South Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.
  • Ability to comprehend and willingness to sign an ICF

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.

  • For participants to be treated with bendamustine (Treatment B), prior treatment with bendamustine (within 12 months of the start of study treatment). Participants with prior bendamustine treatment (> 12 months before the start of study treatment) are eligible if they meet the following criteria:

    • Did not discontinue because of tolerability concerns.
    • Achieved either partial response (PR) or complete response (CR) to the bendamustine regimen of at least 12 months in duration before relapse/progression.
    • Experienced progression following a regimen containing an alkylating agent.
  • For participants to be treated with ibrutinib (Treatment C), prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor.
  • Allogeneic stem cell transplant within the last 6 months or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment.
  • Active graft-versus-host disease following allogeneic transplant.
  • Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A
Parsaclisib + Rituximab
Drug: Parsaclisib
Parsaclisib administered orally once daily for 8 weeks followed by once weekly.
Other Names:
  • INCB050465
Drug: Rituximab
Rituximab administered intravenously at the protocol-defined dose regimen according to treatment group.
Other Names:
  • Rituxan
Experimental: Treatment B
Parsaclisib + Bendamustine + Rituximab
Drug: Parsaclisib
Parsaclisib administered orally once daily for 8 weeks followed by once weekly.
Other Names:
  • INCB050465
Drug: Rituximab
Rituximab administered intravenously at the protocol-defined dose regimen according to treatment group.
Other Names:
  • Rituxan
Drug: Bendamustine
Bendamustine administered intravenously on Days 1 and 2 of each cycle for up to 6 cycles.
Other Names:
  • Treanda, Bendeka
Experimental: Treatment C
Parsaclisib + Ibrutinib
Drug: Parsaclisib
Parsaclisib administered orally once daily for 8 weeks followed by once weekly.
Other Names:
  • INCB050465
Drug: Ibrutinib
Ibrutinib administered orally once daily.
Other Names:
  • Imbruvica

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of treatment-emergent adverse events (TEAEs)
Time Frame: Up to approximately 12 months.
A TEAE is any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Up to approximately 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apparent clearance of parsaclisibin combination with rituximab, bendamustine and rituximab, or ibrutinib
Time Frame: Up to approximately 1 month.
Measured to assess the plasma pharmacokinetic profile of parsaclisib in combination with rituximab, bendamustine and rituximab, and ibrutinib.
Up to approximately 1 month.
Apparent volume of distribution of parsaclisib in combination with rituximab, bendamustine and rituximab, or ibrutinib
Time Frame: Up to approximately 1 month.
Measured to assess the plasma pharmacokinetic profile of parsaclisib in combination with rituximab, bendamustine and rituximab, and ibrutinib.
Up to approximately 1 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: Peter Langmuir, MD, Incyte Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2018

Primary Completion (Actual)

June 27, 2022

Study Completion (Actual)

June 27, 2022

Study Registration Dates

First Submitted

January 25, 2018

First Submitted That Met QC Criteria

January 31, 2018

First Posted (Actual)

February 6, 2018

Study Record Updates

Last Update Posted (Actual)

August 21, 2025

Last Update Submitted That Met QC Criteria

August 19, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 50465-112 (CITADEL-112)
  • Parsaclisib (Other Identifier: Incyte Corporation)
  • 2017-004088-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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