The randomized Phase II study with Telintra tablets in myelodysplastic syndrome (MDS) is expected to enroll 86 patients, with an anticipated 20 sites participating in the study. Two dose schedules of Telintra tablets will be evaluated in low-to-intermediate one risk MDS patients. The primary objective of the study is to determine the hematologic improvement rate in erythroid or red blood cell precursors in each treatment group as assessed by the International Working Group criteria.
One group of patients will be given a starting dose of 4500mg of Telintra daily in divided doses for two weeks followed by one week off therapy. The second group of patients will receive the same dose of Telintra for three weeks followed by one week off therapy. Patients will receive treatment for up to six months, and if patients are continuing to receive clinical benefit after this initial period, the treatment may be extended for an additional six months with continuous daily dosing.
A randomized Phase II study with Telintra tablets in chemotherapy-induced neutropenia (CIN) is expected to enroll 135 patients and is expected to be conducted at 24 sites. One group of 90 patients will receive chemotherapy followed the next day by a starting dose of 4500mg of Telintra per day in twice daily divided doses until white blood cell count recovery. Another group of 45 patients will be the chemotherapy-alone control group, which will receive standard supportive care following chemotherapy. The study’s objective is to evaluate the effect of oral Telintra on accelerating hematologic recovery from chemotherapy.