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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Clínic 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 Clínico Universitario de Salamanca
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Incyte Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 27, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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