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news.Cell Therapeutics has completed enrollment in a phase III study of Trisenox consolidation treatment in patients with newly diagnosed acute promyelocytic leukemia.
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The study is being conducted under a cooperative R&D agreement (CRADA) between Cell Therapeutics Inc (CTI) and the US National Cancer Institute (NCI) and involves three of the largest adult cooperative groups; the Eastern Cooperative Oncology Group (ECOG), the Southwest Oncology Group (SWOG), and the Cancer and Leukemia Group B (CALGB), along with the National Cancer Institute of Canada (NCIC) and the Children’s Oncology Group (COG).
If Trisenox (arsenic trioxide) improves event-free survival, CTI may explore the potential to use the results to file a supplemental new drug application (sNDA) for Trisenox in first-line, consolidation for acute promyelocytic leukemia (APL) patients.
CTI currently markets Trisenox in the US and Europe for the treatment of patients with APL who have relapsed from or who are refractory to standard chemotherapy.