Consolidation Therapy With Lenalidomide (Revlimid®) With or Without Rituximab Followed by Maintenance Therapy With Revlimid® After Autologous/Syngeneic Transplant for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- To evaluate the efficacy of consolidation therapy comprising lenalidomide with or
without rituximab followed by maintenance therapy comprising lenalidomide in patients
with chronic lymphocytic leukemia or small lymphocytic lymphoma who have undergone
autologous or syngeneic stem cell transplantation.
- Consolidation phase: Patients are assigned to 1 of 2 treatment groups.
- Group I: Patients receive oral lenalidomide once daily on days 1-14. Treatment
repeats every 21 days for 8 courses in the absence of disease progression or
- Group II: Patients receive lenalidomide as in group I. Patients also receive
rituximab IV once on the day before the start of lenalidomide and then once
between days 25-30, 50-55, and 75-80 for a total of 4 doses in the absence of
disease progression or unacceptable toxicity.
- Maintenance phase: Beginning 2 months after completion of consolidation therapy, all
patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28
days for 18 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 28 days and then annually
Masking: Open Label, Primary Purpose: Treatment
Efficacy of lenalidomide with or without rituximab as consolidation therapy and lenalidomide as maintenance therapy
Leona A. Holmberg, MD, PhD
Fred Hutchinson Cancer Research Center
United States: Food and Drug Administration