Umbralisib and Rituximab as Initial Therapy for Patients With Follicular Lymphoma and Marginal Zone Lymphoma

Conditions

Umbralisib — DRUG
Umbralisib is an investigational drug which blocks a protein called PI3K. PI3K is a protein that plays a role in the way cells grow. In this type of cancer, PI3K is increased and more active than usual. This helps the cancer cells to grow and survive.
Rituximab — DRUG
Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells

This research is being done to assess Umbralisib and Rituximab as a first line therapy for Follicular Lymphoma or Marginal Zone Lymphoma.

Experimental: Umbralisib+Rituximab
* A treatment cycle is defined as 28 consecutive days. * Umbralisib will be administered at 800 mg by mouth once daily on days 1-28 of cycles 1-24. * Rituximab will be administered at 375 mg/m2 by intravenous infusion on Cycle 1 Day 1 and may be administered at 375 mg/m2 by intravenous infusion or at 1400 mg by subcutaneous injection on days 8, 15, 22 of cycle 1, day 1 of cycles 2 to 6, then every 8 weeks starting on day 1 of cycle 7 until completion of 24 cycles of umbralisib (i.e. every other cycle for 18 cycles or 9 doses, for a total of 15 doses of rituximab), or until progression or intolerance.

Complete Response Rate [ Time Frame: 2 years ]

Facility	City	State	ZIP	Site coordinators
Beth Israel Deaconness Medical Center	Boston	Massachusetts	02215	-
Massachusetts General Hospital Cancer Center	Boston	Massachusetts	02114	-

By research site