Status:
COMPLETED
A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor
Lead Sponsor:
Incyte Corporation
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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) pr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
November 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT03235544
Start Date
November 20 2017
End Date
April 30 2024
Last Update
March 18 2025
Active Locations (103)
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1
University of Alabama At Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35205
2
St. Joseph Heritage Healthcare
Santa Rosa, California, United States, 95403
3
Rocky Mountain Cancer Center-Aurora
Aurora, Colorado, United States, 80012
4
Asclepes Research Centers
Brooksville, Florida, United States, 34613