A phase 3 clinical trial evaluating the use of lenalidomide (Revlimid, Celgene) in 450 patients with chronic lymphocytic leukemia (CLL) has been stopped.
The trial was exploring CLL as a new indication for lenalidomide, which is marketed for the treatment of multiple myeloma.
The manufacturer, Celgene Corporation, announced on July 18 that it was discontinuing the trial after consultation with the US Food and Drug Administration (FDA).
On July 12, the FDA put a clinical hold on the trial, citing "significant safety concerns," after a preliminary analysis of the data showed a higher probability of death with lenalidomide than with chlorambucil, the comparator medication. The FDA also "determined that the clinical trial is unlikely to achieve its main objective to reduce the amount of time for the leukemia to progress or the patient to die."
The trial, known as ORIGIN, was comparing the single-agent use of lenalidomide with that of chlorambucil for initial therapy in patients 65 years and older with B-cell CLL and comorbidities that preclude treatment with a more aggressive standard chemoimmunotherapy, including fludarabine- and bendamustine-containing regimens. The majority of patients presented with multiple comorbidities, such as diabetes, congestive heart failure, renal impairment, and elevated bilirubin count, the company noted.
In the preliminary survival data, there was an imbalance in deaths reported in the 2 groups. There were 34 deaths in the 210 patients treated with lenalidomide and 18 deaths in the 211 patients treated with chlorambucil (overall survival hazard ratio, 1.92; 95% confidence interval, 1.08 - 3.41).
To date, no specific cause for this imbalance has been identified, according to Celgene.
The FDA emphasized that lenalidomide is still considered safe and effective for its approved indications, including the treatment of multiple myeloma in combination with dexamethasone in patients who have received at least 1 previous medication, the treatment of myelodysplastic syndrome in patients with a chromosome 5q deletion, and the treatment of mantle cell lymphoma in patients whose disease has not responded or has re-emerged after treatment with at least 2 therapies, 1 of which was bortezomib (Velcade).
Medscape Medical News © 2013 WebMD, LLC
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Cite this: Lenalidomide Leukemia Clinical Trial Stopped - Medscape - Jul 22, 2013.