In the trial patients with relapsed or refractory chronic lymphocytic leukemia (CLL) received fludarabine plus cyclophosphamide chemotherapy with or without Genasense.
This trial achieved its primary endpoint, which was a statistically significant increase in the proportion of patients who achieved a complete or nodular partial response (CR/nPR).
Patients who achieved CR/nPR experienced the disappearance of all predefined symptoms, including fever, night sweats, fatigue, abdominal discomfort due to an enlarged spleen, and impaired mobility due to swollen lymph nodes.
The key secondary endpoint was duration of CR/nPR which was also significantly longer for patients treated with Genasense.
Among patients who achieved a CR/nPR with Genasense, 70% were alive at three years versus 38% for the control arm.