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Pilot studies of the oral BCL2 inhibitor venetoclax showed marked clinical activity in patients with relapsed chronic lymphocytic leukemia (CLL), but with risk for severe or fatal tumor lysis syndrome (TLS). Investigators have now conducted a phase I, manufacturer-funded, dose-escalation trial in patients with relapsed or refractory CLL or small lymphocytic lymphoma.
Aggressive, inpatient-based laboratory monitoring and hydration regimens were employed for 24 hours during initial dosing at the 20-mg and 50-mg levels. Daily treatment was continued until disease progressed or toxicity became unacceptable.
Of 116 enrolled patients, 79% responded and 20% had complete remission. Of the 17 patients with complete remission who underwent peripheral-b…