Clinical Trial TitleA phase 2, open-label, 2-cohort, multicenter study of INCB050465, a PI3Kδ inhibitor, in relapsed or refractory mantle cell lymphoma previously treated with or without a BTK inhibitor (CITADEL-205).
Clinical Trial Protocol Description:
The purpose of this study is to find out if INCB050465 (study drug) is safe and effective in people who have relapsed or refractory mantle cell lymphoma. This study will evaluate two different dosing regimens of the study drug. INCB050465 tablets will be taken once a day for 8 weeks followed by once a week at the same dose for the rest of the study. The duration of participation in this study is expected to be approximately two years.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have relapsed or refractory mantle cell lymphoma.
- Have radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.
You will be excluded from the study if any of the following criteria apply to you:
- Have a history of central nervous system lymphoma (either primary or metastatic).
- Have had prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan PI3K inhibitor.
- Have had an 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.
- Have active graft-versus-host disease.
- Have liver disease.
- Have evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation. HBV DNA and HCV RNA must be undetectable. Subjects cannot be positive for hepatitis B surface antigen or anti-hepatitis B core antibody.
This is a partial list of inclusion and exclusion criteria.