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

NCT03424122 | Completed Phase 1 FDA Drug

• 3 other identifiers: INCB 50465-112 (CITADEL-112)Parsaclisib2017-004088-11
• Study Type: interventional
• Target: 50
• Locations: 3 countries
• Sites: 21

Brief 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.

Conditions

B-cell Lymphoma

Keywords

Diffuse large B-cell lymphoma (DLBCL); follicular lymphoma (FL); marginal zone lymphoma (MZL); mantle cell lymphoma (MCL); phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor

Outcome Measures

Primary Outcomes (1)

• Number of treatment-emergent adverse events (TEAEs)

  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 Outcomes (2)

• Apparent clearance of parsaclisibin combination with rituximab, bendamustine and rituximab, or ibrutinib

  Up to approximately 1 month.

• Apparent volume of distribution of parsaclisib in combination with rituximab, bendamustine and rituximab, or ibrutinib

  Up to approximately 1 month.

Study Arms (3)

Treatment A

EXPERIMENTAL

Parsaclisib + Rituximab

Drug: Parsaclisib; Drug: Rituximab

Treatment B

EXPERIMENTAL

Parsaclisib + Bendamustine + Rituximab

Drug: Parsaclisib; Drug: Rituximab; Drug: Bendamustine

Treatment C

EXPERIMENTAL

Parsaclisib + Ibrutinib

Drug: Parsaclisib; Drug: Ibrutinib

Interventions

Parsaclisib DRUG

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

Also known as: INCB050465

Treatment A; Treatment B; Treatment C

Rituximab DRUG

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

Also known as: Rituxan

Treatment A; Treatment B

Bendamustine DRUG

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

Also known as: Treanda, Bendeka

Treatment B

Ibrutinib DRUG

Ibrutinib administered orally once daily.

Also known as: Imbruvica

Treatment C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (21)

University of Arizona Cancer Center - Out Pt.

Tucson, Arizona, 85719, United States

Location

Indiana Blood and Marrow Transplantation

Indianapolis, Indiana, 46237, United States

Location

Comprehensive Cancer Center of Nevada

Las Vegas, Nevada, 89169, United States

Location

Texas Oncology

Austin, Texas, 78705, United States

Location

Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Smith Clinic

Houston, Texas, 77054, United States

Location

Cancer Care Centers of South Texas

San Antonio, Texas, 78217, United States

Location

Texas Oncology San Antonio

San Antonio, Texas, 78240, United States

Location

Asst Spedali Civili Di Brescia

Brescia, 25123, Italy

Location

Azienda Ospedaliera San Gerardo Di Monza

Monza, 20835, Italy

Location

Azienda Ospedaliera Universitaria Pisana

Pisa, 56126, Italy

Location

Ospedale Delle Croci - Ematologia Ravenna

Ravenna, 48121, Italy

Location

Hospital Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hospital General Universitari Vall D Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic I Provincial

Barcelona, 08036, Spain

Location

Fundacion Jimenez Diaz University Hospital

Madrid, 28040, Spain

Location

Hospital Universitario Hm Sanchinarro

Madrid, 28050, Spain

Location

Hospital Clinico Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

Hospital Universitario Y Politecnic La Fe

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Mantle-Cell

Interventions

parsaclisib; Rituximab; Bendamustine Hydrochloride; ibrutinib

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Peter Langmuir, MD

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 6, 2018
• Study Start: July 2, 2018
• Primary Completion: June 27, 2022
• Study Completion: June 27, 2022
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (9); IT (4); ES (8)