RWF_RU051305S

A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide CC-5013 Versus Rituximab Plus Placebo in Subjects With Relapsed/Refractory Indolent Lymphoma - The AUGMENT Study

This double-blind randomized, parallel group study will evaluate the efficacy and safety of lenalidomide (Revlimid, CC-5013) in combination with rituximab (MabThera/Rituxan) in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma. Patients will be randomized to receive either lenalidomide or placebo for twelve 28-day cycles in combination with rituximab. Anticipated time on study treatment is 1 year.

Inclusion Criteria:

• Histologically confirmed marginal zone lymphoma or follicular lymphoma (grade 1, 2 or 3a; CD20+ by flow cytometry or histochemistry).

• Bi-dimensionally measurable disease on cross sectional imaging by X-ray Computed Tomography (CT) or Magnetic Resonance Imaging (MRI).

Phase III
NCT01938001
Oncology
Hematologic
John Godwin, M.D.
ACCRU
Laurie Delanty
  • Oncology and Hematology Care Eastside
  • Oncology and Hematology Care Westside