Lenalidomide/Rituximab Maintenance After Induction With Fludarabine/Rituximab In Combination With Escalating Doses Of Lenalidomide In Previously Untreated Chronic Lymphocytic Leukemia (CLL): The Revlirit CLL5 AGMT Phase I/II Study, Final Results
Egle A, Steurer M, Gassner FJ, Geisberger R, et al.
Key Points:
Phase I/II clinical trial of lenalidomide/rituximab maintenance after induction with fludarabine/rituximab and escalating doses of lenalidomide.
In induction part fludarabine (40mg/m2 po d1-3 q28d) and rituximab (375mg/m2 iv d4 cycle 1; 500mg/m2 iv d1 cycles 2-6, q28d) added to lenalidomide day 7-21 at 2.5 mg and dose was escalated based on tolerability.
Maintenance treatment two-monthly rituximab at 375mg/m2 and lenalidomide at last dose tolerated in 28-day cycle for 6 months.
Of 45 patients, median daily dose in cycle 6 15 mg in 40 evaluable patients, with 3 patients receiving the last cycle without lenalidomide; major toxicity neutropenia but no G4 infections observed in 5% of patients.
Implications:
- Combination of lenalidomide with FR followed by maintenance with lenalidomide and rituximab clinically feasible; PFS 89% and currently 46 months.
View the original abstract on the ASH website.
