Conditions: Mantle Cell Lymphoma
Keywords: Mantle Cell Lymphoma Rituximab Lenalidomide Bortezomib Phase 1/2
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 39
Healthy volunteers: no

Brief summary:
This is a Phase I/II multicenter, open-label, dose-escalation study of rituximab, bortezomib, and lenalidomide in the first-line or second-line treatment of patients with Mantle Cell Lymphoma (MCL).

Detailed description:
The combination of lenalidomide with bortezomib has not been studied in patients with MCL, but feasibility and tolerability has been demonstrated in patients with multiple myeloma. Thus, almost every 2-drug combination of rituximab, lenalidomide, and bortezomib has been tested, or is being tested. We hypothesize that all three drugs are important in MCL, and therefore propose to combine all 3 agents (rituximab, bortezomib, and lenalidomide) in a schedule that is convenient to lymphoma patients.

Approximately 18 patients may be enrolled in the Phase I portion of the study. Approximately 45 patients are planned for enrollment in Phase II.

Arms:
arm 1: Patients in Phase I \& II to receive treatment with rituximab, bortezomib and lenalidomide in 21-day cycles up to 6 cycles.

Phase I: Cohorts of 3 patients will be enrolled at escalating dose levels to determine the maximum tolerated dose (MTD). Doses may be de-escalated if necessary.

Phase II: patients will be treated with the MTD determined in Phase I.

Interventions: intervention 1: Rituximab intervention 2: Bortezomib intervention 3: Lenalidomide
Intervention descriptions: intervention 1: DL 1, DL 2, and DL 3: 375 mg/m2 IV Days 1, 8, and 15; Cycles 2-6: 375 mg/m2 IV Day 1

Same for DL-1. intervention 2: DL 1, DL 2, and DL 3: 1.3 mg/m2 IV Days 1, 4, 8, and 11

Same for DL-1. intervention 3: DL 1: 15 mg PO daily Days 1-14 followed by 7 days of rest

DL 2: 20 mg PO daily Days 1-14 followed by 7 days of rest

DL 3: 25 mg PO daily Days 1-14 followed by 7 days of rest

DL-1: 10 mg PO daily Days 1-14 followed by 7 days of rest

Protocol document: