Status:
COMPLETED
INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)
Lead Sponsor:
Incyte Corporation
Conditions:
B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03424122
Start Date
July 2 2018
End Date
June 27 2022
Last Update
August 21 2025
Active Locations (21)
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1
University of Arizona Cancer Center - Out Pt.
Tucson, Arizona, United States, 85719
2
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, United States, 46237
3
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
4
Texas Oncology
Austin, Texas, United States, 78705