A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)
This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in subjects with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Men and women, aged 18 years or older.
- Documented failure to achieve at least 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.
- History of central nervous system lymphoma (either primary or metastatic).
- 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 first dose of study treatment.
- Active graft-versus-host disease.
- Liver 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.
- Phase 2
- Study Type
- Intervention Model
- Sequential Assignment
- Primary Purpose
- None (Open Label)
Cohort 1- Parsaclisib
|Participants who have previously received ibrutinib.||
Cohort 2 - Parsaclisib
|Participants who have not previously received a BTK inhibitor.||
- Incyte Corporation
Study ContactIncyte Corporation Call Center (US)