Celgene International has announced interim results of CLL-009 followed by step-wise dose escalation as tolerated in patients with chronic lymphocytic leukemia (CLL) who received at least one prior therapy.

CLL-009 is a study evaluating three starting doses of REVLIMID (lenalidomide).

The objective of the study is to determine the safety and efficacy of different lenalidomide dose regimens in subjects with relapsed or refractory CLL.

In the study, patients are being enrolled and randomized to receive a blinded starting dose of 5mg, 10mg or 15mg of lenalidomide daily for each 28-day cycle.

Dose escalation may take place every 28 days, in 5mg/day increments, as tolerated.

Tumor lysis syndrome (TLS) prophylaxis was initiated at least three days prior to initiating lenalidomide and for a minimum of the first three treatment cycles.

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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.

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 tumour 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 (n=11) and progressive disease (n=9).

Six patients died, two due to disease progression, two due to pneumonia, one due to pneumonia (suspected treatment related) and one due to an unknown cause (suspected treatment related).

REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma. It is not approved for chronic lymphocytic leukemia.