A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor

Completed · Phase 2

Conditions studied: Lymphoma

In brief

This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.

Key facts

Study ID

NCT03235544

Run by

Incyte Corporation

People needed

162

Starts

2017-11-20

Expected to finish

2024-04-30

Last updated by the study team

2025-03-18

Who can join

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

You may qualify if…

• Men and women, aged 18 years or older.
• Documented failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen.
• Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

You may not qualify if…

• History of central nervous system lymphoma (either primary or metastatic).
• Prior treatment with idelalisib, other selective phosphatidylinositol 3-kinase delta (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 first dose of study treatment.
• Active graft-versus-host disease.
• Liver disease: Participants positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for hepatitis B virus-deoxyribonucleic acid (HBV-DNA). Participants positive for anti-hepatitis C virus (HCV) antibody will be eligible if they are negative for HCV-ribonucleic acid (RNA).

Where it is running

• St. Joseph Heritage Healthcare — Santa Rosa, California, United States
• Rocky Mountain Cancer Center-Aurora — Aurora, Colorado, United States
• Asclepes Research Centers — Brooksville, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Bond & Steele Clinic, P.A. — Winter Haven, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Illinois Cancer Specialists — Niles, Illinois, United States
• Hattiesburg Clinic Hematology — Hattiesburg, Mississippi, United States
• Clinical Research Alliance, Inc. — New Hyde Park, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Oncology Hematology Care, Inc. — Cincinnati, Ohio, United States
• Willamette Valley Cancer Institute — Eugene, Oregon, United States
• Kaiser Permanente - Northwest — Portland, Oregon, United States
• Gettysburg Cancer Center — Gettysburg, Pennsylvania, United States
• Texas Oncology — Austin, Texas, United States
• Texas Oncology San Antonio — San Antonio, Texas, United States
• Renovatio Clinical — The Woodlands, Texas, United States
• Texas Oncology - Tyler — Tyler, Texas, United States
• Yakima Valley Memorial Hospital/North Star — Yakima, Washington, United States
• Universitair Ziekenhuis Gent — Ghent, Oost-Vlaanderen, Belgium
• Institut Jules Bordet — Brussels, Belgium
• Hopital de Jolimont — La Louvière, Belgium
• Universitaire Ziekenhuis Leuven - Gasthuisberg — Leuven, Belgium
• University of Alabama At Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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