Lenalidomide, Ixazomib, and Rituximab as Front-Line Therapy for High Risk Indolent B-Cell Lymphoma

Conditions

Ixazomib — DRUG
The prescribed administration of ixazomib doses in this study is 2.0, 3.0 or 4.0 mg ixazomib on days 1, 8 and 15 of each 28 day cycle.
Lenalidomide — DRUG
Lenalidomide starting dose will be based on baseline calculated creatinine clearance as follows: * Starting lenalidomide Dose (20mg) * Calculated Creatinine Clearance: \>=60ml/min receive 20 mg daily on Days 1 - 21 of each 28-day cycle * Calculated Creatinine Clearance: \>= 30 and \< 60 ml/min receive 10 mg daily on Days 1 - 21 of each 28-day cycle
Rituximab — DRUG
Rituximab is administered intravenously at 375mg/m2 on days 1, 8, and 15 of cycle 1, day 1 of cycles 2-6 and day 1 of cycles 8, 10, and 12.

A Phase IB/II Trial of Lenalidomide (Revlimid®), Ixazomib and Rituximab (RIXAR) as Front-line Therapy for High Risk Indolent B cell Lymphoma

Experimental: Lenalidomide + Ixazomib + Rituximab
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.

Maximum Tolerated Dose (MTD) of Oral Ixazomib [ Time Frame: 15 months after beginning treatment ]

Facility	City	State	ZIP	Site coordinators
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio	44195	-
University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio	44106	-

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