Spectrum Pharmaceuticals announced results from a prospective Phase 2 single-arm, open-label, multicenter clinical trial studying the management of oral mucositis with the use of oral leucovorin as adjunct to FOLOTYN in patients with hematological malignancies, including PTCL and CTCL. Study results with a total of 35 patients demonstrated that use of leucovorin 25 mg tablets by oral administration for two days, initiated 24 hours after each FOLOTYN dose reduced the rate of Grade 2 or greater mucositis significantly, to 5.7 percent from historic rate associated with FOLOTYN use. There were no reports of greater than or equal to Grade 3 oral mucositis. Grade 1 oral mucositis was reported only in 4 patients. No patient omitted, delayed or reduced FOLOTYN dose due to oral mucositis with adjunct leucovorin therapy. The occurrence of mucositis, an impediment of FOLOTYN, has previously been reported at a rate of 52 percent at Grade 2 or higher in patients undergoing treatment with FOLOTYN in a registration study.
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