Marginal Zone Lymphoma Treatment Study
Lymphoma is the most common blood cancer. The two main forms of lymphoma are Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). Marginal zone lymphomas (MZL) are a group of slow-growing NHL B-cell lymphomas, which account for approximately 12 percent of all B-cell lymphomas.
This is a phase 2, open-label, 2-cohort study designed to evaluate the safety and effectiveness of two treatment regimens with INCB050465 in subjects whose disease has come back (relapsed) or did not respond to other treatments (refractory) marginal zone MZL.
The study will include subjects with all the types of lymphoma: extranodal, nodal and splenic. The two cohorts are: subjects whose treatment had included ibrutinib (a BTK inhibitor) before; subjects whose treatment did not include a prior BTK inhibitor.
Cohorts 1 and 2 will be further broken down to receive two different treatment regimens:
- Treatment A: INCB050465 – 20 milligrams once daily for 8 weeks followed by 20 milligrams once weekly.
- Treatment B: INCB050465 – 20 milligrams once daily for 8 weeks followed by 2.5 milligrams once daily.
INCB050465 has effects on the immune system. Subjects in this study will be monitored closely for evidence of infections or new cancers, and study treatment will be discontinued if there is evidence of clinically significant infection or new cancer.
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Have confirmed marginal zone lymphoma, including extranodal, nodal, and splenic subtypes.
- Have received 1 or more cancer treatments, including at least 1 anti-CD20 antibody, and experienced disease progression or your disease failed to respond to treatment.
- Have adequate blood, liver and kidney function.
You will be excluded from the study if any of the following criteria apply to you:
- Have evidence of diffuse large B-cell lymphoma (DLBCL) transformation.
- Have had prior treatment with idelalisib.
- Have had an allogeneic stem cell transplant within 6 months, or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment.
- Are unable to swallow and retain oral medications.
This is a partial list of inclusion and exclusion criteria.