A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)

• Status: Active, not recruiting
• Trial end date: 2022-07-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.