INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)
NCT ID: NCT03424122
Last Updated: 2025-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2018-07-02
2022-06-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment A
Parsaclisib + Rituximab
Parsaclisib
Parsaclisib administered orally once daily for 8 weeks followed by once weekly.
Rituximab
Rituximab administered intravenously at the protocol-defined dose regimen according to treatment group.
Treatment B
Parsaclisib + Bendamustine + Rituximab
Parsaclisib
Parsaclisib administered orally once daily for 8 weeks followed by once weekly.
Rituximab
Rituximab administered intravenously at the protocol-defined dose regimen according to treatment group.
Bendamustine
Bendamustine administered intravenously on Days 1 and 2 of each cycle for up to 6 cycles.
Treatment C
Parsaclisib + Ibrutinib
Parsaclisib
Parsaclisib administered orally once daily for 8 weeks followed by once weekly.
Ibrutinib
Ibrutinib administered orally once daily.
Interventions
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Parsaclisib
Parsaclisib administered orally once daily for 8 weeks followed by once weekly.
Rituximab
Rituximab administered intravenously at the protocol-defined dose regimen according to treatment group.
Bendamustine
Bendamustine administered intravenously on Days 1 and 2 of each cycle for up to 6 cycles.
Ibrutinib
Ibrutinib administered orally once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Langmuir, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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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
Azienda Ospedaliera San Gerardo Di Monza
Monza, , Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, , Italy
Ospedale Delle Croci - Ematologia Ravenna
Ravenna, , Italy
Hospital Germans Trias I Pujol
Badalona, , Spain
Hospital General Universitari Vall D Hebron
Barcelona, , Spain
Hospital Clinic I Provincial
Barcelona, , Spain
Fundacion Jimenez Diaz University Hospital
Madrid, , Spain
Hospital Universitario Hm Sanchinarro
Madrid, , Spain
Hospital Clinico Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital Universitario Y Politecnic La Fe
Valencia, , Spain
Countries
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Other Identifiers
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Parsaclisib
Identifier Type: OTHER
Identifier Source: secondary_id
2017-004088-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 50465-112 (CITADEL-112)
Identifier Type: -
Identifier Source: org_study_id
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