A Phase I/II Study to Assess the Safety and Tolerability of APO866 for the Treatment of Refractory B-CLL
Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
Participant gender:
Summary
This phase I/II study is designed to determine the safety and tolerability of APO866 for the
treatment of refractory B-CLL not amenable to aHSCT. APO866 has shown to induce growth
inhibition in cultures of a wide variety of human hematological malignant cells as well as in
models with subcutaneously implanted human tumors. APO866 was considered to be safe and
well-tolerated in a phase I study that treated 24 patients with advanced cancer. APO866 is
administered by intravenous infusion continuously for 96 hours and is repeated every 4 weeks.
In this study patients will receive only one cycle of treatment and the study endpoints will
be evaluated 4 weeks after the start of infusion. Patients will be followed up for 12 weeks
for safety.