Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG), announced interim results of CLL-009, a study evaluating three starting doses of REVLIMID® (lenalidomide), followed by step-wise dose escalation as tolerated in patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. The findings were presented during the 53rd Annual Meeting of the American Society of Hematology in San Diego, CA.
In this ongoing study, patients are being enrolled and randomized to receive a blinded starting dose of 5 mg, 10 mg or 15 mg of lenalidomide daily for each 28-day cycle. The objectives of the study are to determine the safety and efficacy of different lenalidomide dose regimens in subjects with relapsed or refractory CLL. Dose escalation may take place every 28 days, in 5 mg/day increments, as tolerated. Tumor lysis syndrome (TLS) prophylaxis, comprising oral hydration and allopurinol 300 mg/day, was initiated at least three days prior to initiating lenalidomide and for a minimum of the first three treatment cycles.
At the time of the analysis, 60 out of 90 patients had been enrolled, and 29/46 (63% of eligible patients) had successful dose escalation above their starting dose levels.
Twenty-nine patients have been assessed for response, resulting in one (3%) complete response, 10 (35%) partial responses, 14 (48%) patients with stable disease, two (7%) patients with progressive disease and two (7%) patients who were not evaluable, resulting in an overall response rate (CR + PR) of 38%.
The most common grade 3/4 adverse events observed in the study were neutropenia (52%, 31/60), thrombocytopenia (25%, 15/60), fatigue (13%, 8/60) and tumor flare (10%, 6/60). Two patients experienced TLS with another experiencing laboratory TLS. Lenalidomide was discontinued in 29/60 (48%) patients, most commonly due to AE.
These data are from an investigational study. REVLIMID is not approved for chronic lymphocytic leukemia.
Celgene International Sàrl