- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03424122
INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)
June 27, 2022 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
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Brescia, Italy, 25123
- ASST Spedali Civili di Brescia
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Monza, Italy, 20835
- Azienda Ospedaliera San Gerardo di Monza
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Pisa, Italy, 56126
- Azienda Ospedaliera Universitaria Pisana
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Ravenna, Italy, 48121
- Ospedale Delle Croci - Ematologia Ravenna
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Badalona, Spain, 08916
- Hospital Germans Trias i Pujol
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Barcelona, Spain, 08036
- Hospital Clinic I Provincial
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Barcelona, Spain, 08035
- Hospital General Universitari Vall D Hebron
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Madrid, Spain, 28040
- Fundacion Jimenez Diaz University Hospital
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Madrid, Spain, 28050
- Hospital Universitario HM Sanchinarro
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Salamanca, Spain, 37007
- Hospital Clinico Universitario de Salamanca
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Sevilla, Spain, 41013
- Hospital Universitario Virgen del Rocio
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Valencia, Spain, 46026
- Hospital Universitario Y Politecnic La Fe
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Arizona
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Tucson, Arizona, United States, 85719
- University of Arizona Cancer Center - Out Pt.
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Indiana
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Indianapolis, Indiana, United States, 46237
- Indiana Blood and Marrow Transplantation
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Nevada
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Las Vegas, Nevada, United States, 89169
- Comprehensive Cancer Center of Nevada
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Texas
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Austin, Texas, United States, 78705
- Texas Oncology
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Dallas, Texas, United States, 75246
- Baylor Charles A. Sammons Cancer Center
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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Houston, Texas, United States, 77054
- Smith Clinic
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San Antonio, Texas, United States, 78240
- Texas Oncology San Antonio
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San Antonio, Texas, United States, 78217
- Cancer Care Centers of South Texas
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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
Genders Eligible for Study
All
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
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Parsaclisib administered orally once daily for 8 weeks followed by once weekly.
Other Names:
Rituximab administered intravenously at the protocol-defined dose regimen according to treatment group.
Other Names:
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Experimental: Treatment B
Parsaclisib + Bendamustine + Rituximab
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Parsaclisib administered orally once daily for 8 weeks followed by once weekly.
Other Names:
Rituximab administered intravenously at the protocol-defined dose regimen according to treatment group.
Other Names:
Bendamustine administered intravenously on Days 1 and 2 of each cycle for up to 6 cycles.
Other Names:
|
Experimental: Treatment C
Parsaclisib + Ibrutinib
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Parsaclisib administered orally once daily for 8 weeks followed by once weekly.
Other Names:
Ibrutinib administered orally once daily.
Other Names:
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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.
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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.
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Up to approximately 12 months.
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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.
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Measured to assess the plasma pharmacokinetic profile of parsaclisib in combination with rituximab, bendamustine and rituximab, and ibrutinib.
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Up to approximately 1 month.
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Apparent volume of distribution of parsaclisib in combination with rituximab, bendamustine and rituximab, or ibrutinib
Time Frame: Up to approximately 1 month.
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Measured to assess the plasma pharmacokinetic profile of parsaclisib in combination with rituximab, bendamustine and rituximab, and ibrutinib.
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Up to approximately 1 month.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
June 29, 2022
Last Update Submitted That Met QC Criteria
June 27, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, B-Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Antineoplastic Agents, Immunological
- Bendamustine Hydrochloride
- Rituximab
Other Study ID Numbers
- INCB 50465-112 (CITADEL-112)
- Parsaclisib (Other Identifier: Incyte Corporation)
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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