Phase I/II Study of Genasense in Patients With Chronic Lymphocytic Leukemia

Phase I-II Multicenter Study of Genasense (Bcl-2 Antisense Oligonucleotide) in Patients With Advanced Chronic Lymphocytic Leukemia

This non-randomized study will test the safety and effectiveness of Genasense in patients with CLL.

This study is a two-part phase I-II study. Part 1 will determine the MTD of Genasense in patients with CLL. This dose will then be tested in a non-randomized, multi-center, Phase II sequential clinical trial of Genasense used alone for treatment of patients with advanced CLL.

Pharmacokinetics of Genasense and kinetics of Bcl-2 down regulation and re-expression in CLL cells will be followed in selected patients.

• Any age
• Must have received at least one chemotherapy regimen that included fludarabine
• Measurable disease
• At least 3 weeks since biological therapy or radiation therapy for chronic lymphocytic leukemia
• No previous stem cell transplantation
• At least 3 weeks since surgery