Skip to main content
OpenTrials
Completed

NCT Number: NCT03424122

INCB050465 in Combination With 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Asst Spedali Civili Di Brescia, Brescia, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parsaclisib

Drug

Parsaclisib administered orally once daily for 8 weeks followed by once weekly.

Other names: INCB050465

Rituximab

Drug

Rituximab administered intravenously at the protocol-defined dose regimen according to treatment group.

Other names: Rituxan

Bendamustine

Drug

Bendamustine administered intravenously on Days 1 and 2 of each cycle for up to 6 cycles.

Other names: Treanda, Bendeka

Ibrutinib

Drug

Ibrutinib administered orally once daily.

Other names: Imbruvica

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

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)

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 6, 2018
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.