INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)
- Conditions
- B-cell Lymphoma
- Interventions
- Registration Number
- NCT03424122
- Lead Sponsor
- Incyte Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
-
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.
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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.
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Active graft-versus-host disease following allogeneic transplant.
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Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment A Parsaclisib Parsaclisib + Rituximab Treatment A Rituximab Parsaclisib + Rituximab Treatment B Parsaclisib Parsaclisib + Bendamustine + Rituximab Treatment B Rituximab Parsaclisib + Bendamustine + Rituximab Treatment B Bendamustine Parsaclisib + Bendamustine + Rituximab Treatment C Parsaclisib Parsaclisib + Ibrutinib Treatment C Ibrutinib Parsaclisib + Ibrutinib
- Primary Outcome Measures
Name Time Method Number of treatment-emergent adverse events (TEAEs) 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 Outcome Measures
Name Time Method Apparent clearance of parsaclisibin combination with rituximab, bendamustine and rituximab, or ibrutinib Up to approximately 1 month. Measured to assess the plasma pharmacokinetic profile of parsaclisib in combination with rituximab, bendamustine and rituximab, and ibrutinib.
Apparent volume of distribution of parsaclisib in combination with rituximab, bendamustine and rituximab, or ibrutinib Up to approximately 1 month. Measured to assess the plasma pharmacokinetic profile of parsaclisib in combination with rituximab, bendamustine and rituximab, and ibrutinib.
Trial Locations
- Locations (21)
Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
University of Arizona Cancer Center - Out Pt.
🇺🇸Tucson, Arizona, United States
Texas Oncology
🇺🇸Austin, Texas, United States
Indiana Blood and Marrow Transplantation
🇺🇸Indianapolis, Indiana, United States
Comprehensive Cancer Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Hospital Universitario Y Politecnic La Fe
🇪🇸Valencia, Spain
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 Universitaria Pisana
🇮🇹Pisa, Italy
Azienda Ospedaliera San Gerardo Di Monza
🇮🇹Monza, 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
Hospital Clinico Universitario de Salamanca
🇪🇸Salamanca, Spain
Fundacion Jimenez Diaz University Hospital
🇪🇸Madrid, Spain
Hospital Universitario Hm Sanchinarro
🇪🇸Madrid, Spain
Hospital Universitario Virgen Del Rocio
🇪🇸Sevilla, Spain