CTI Announces Enrollment Completion of NCI-Sponsored Cooperative Group Phase III Trial of TRISENOX Consolidation in Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia
Tuesday April 5, 7:00 am ET
- Study Results May Provide Basis for Supplemental NDA (sNDA)
SEATTLE, April 5 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; Nuovo Mercato) announced today 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 Research and Development Agreement (CRADA) between CTI and the U.S. 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 improves event-free survival, CTI may explore the potential to use the results to file a sNDA for TRISENOX in first-line, consolidation for APL patients. CTI markets TRISENOX (arsenic trioxide) in the United States and Europe for the treatment of patients with APL who have relapsed from or who are refractory to standard chemotherapy.
"ATRA plus an anthracycline followed by maintenance ATRA and combination chemotherapy remains the cornerstone for curative treatment of most patients with newly diagnosed, untreated APL, however, between 20 and 30 percent of patients still relapse," stated Jack W. Singer, Chief Medical Officer of CTI. "As a single agent in relapsed/refractory APL, TRISENOX produces a high rate of complete remissions (CRs), mostly molecular CRs and it may be curative as single-agent therapy for some of these patients who have remained relapse-free for several years. This study seeks to determine whether the addition of two, 25 day cycles of TRISENOX consolidation following standard induction therapy can increase the event-free survival for adult patients with APL. If positive, results from this study may provide a basis for inclusion of TRISENOX in first-line therapy of APL, particularly in patients known to be at higher risk for relapse."
About the study
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. |
