A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)

Completed · Phase 2

Conditions studied: Lymphoma

In brief

The purpose of this study is to evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.

Key facts

Study ID

NCT03144674

Run by

Incyte Corporation

People needed

110

Starts

2017-12-18

Expected to finish

2024-05-29

Last updated by the study team

2025-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women, aged 18 or older (except in South Korea, aged 19 or older).
• Histologically confirmed marginal zone lymphoma, including extranodal, nodal, and splenic subtypes.
• Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest transverse diameter and ≥ 1.0 cm in the longest perpendicular diameter.
• Participants with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed.
• Participants must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
• Eastern Cooperative Oncology Group performance status 0 to 2.

You may not qualify if…

• Evidence of diffuse large B-cell transformation.
• History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
• Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K 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.
• Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.

Where it is running

• Arizona Oncology Associates — Tempe, Arizona, United States
• Torrance Health Association — Redondo Beach, California, United States
• Sansum Clinic — Santa Barbara, California, United States
• Central Coast Medical Oncology — Santa Maria, California, United States
• UCLA Healthcare Hematology-Oncology — Santa Monica, California, United States
• St. Joseph Heritage Healthcare — Santa Rosa, California, United States
• Innovative Clinical Research Institute — Whittier, California, United States
• Loyola University Medical Center — Whittier, California, United States
• Valley View Hospital — Glenwood Springs, Colorado, United States
• St. Mary'S Hospital Regional Cancer Center — Grand Junction, Colorado, United States
• University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Advanced Pharma Cr — Miami, Florida, United States
• Boca Raton Clinical Research Medical Inc. — Plantation, Florida, United States
• Asclepes Research Centers — Weeki Wachee, Florida, United States
• Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center - Consultants in Hematology — Chicago, Illinois, United States
• Clinical Trials of Swla Llc — Lake Charles, Louisiana, United States
• University of Michigan Cancer Center — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Saint Luke'S Hospital of Kansas City — Kansas City, Missouri, United States
• COMPREHENSIVE CANCER CeNTERS OF NEVADA - TWAIN — Las Vegas, Nevada, United States
• Clinical Research Alliance — New Hyde Park, New York, United States
• Nyu Cancer Institute — New York, New York, United States
• Hematology Oncology Associates of Rockland — Nyack, New York, United States
• University of Alabama At Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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