CTI Completes Enrollment of Phase III Trial of Trisenox Consolidation

Cell Therapeutics has announced that a Phase III study of Trisenox consolidation treatment in patients with newly diagnosed acute promyelocytic leukemia (APL) completed enrollment with approximately 500 patients.

The study is being conducted under the cooperative R&D agreement between CTI and the U.S. National Cancer Institute and involves three of the largest adult cooperative groups: the Eastern Cooperative Oncology Group, the Southwest Oncology Group, and the Cancer and Leukemia Group B, along with the National Cancer Institute of Canada and the Children's Oncology Group.

If Trisenox (arsenic trioxide) improves event-free survival, CTI may explore the potential to use the results to file a supplemental new drug application for Trisenox in first-line, consolidation for APL patients. CTI markets Trisenox in the U.S. and Europe for the treatment of patients with APL who have relapsed from or who are refractory to standard chemotherapy.

The study, which was initiated in June 1999, seeks to determine if Trisenox consolidation therapy prolongs the event-free survival of untreated, newly diagnosed APL patients when added to the standard induction regimen of ATRA and chemotherapy compared to standard ATRA and chemotherapy alone. A secondary endpoint of the study is to examine the effectiveness of adding chemotherapy to maintenance ATRA therapy compared to maintenance ATRA alone.