Chernihiv

Researchers are evaluating the effects of Radotinib in patients with chronic phase Philadelphia chromosome-positive chronic myeloid leukemia who have not responded well or cannot tolerate previous tyrosine kinase inhibitor treatments, including Imatinib. This multinational Phase III study aims to assess the efficacy and safety of Radotinib in this specific patient group. A total of 173 participants are expected to enroll in this single-arm, open-label trial. Participants will receive Radotinib at a dose of 400 mg twice daily, taken orally every 12 hours, for 12 months. Dose adjustments may be made if participants experience certain blood-related or other toxicities, with up to two reductions allowed per stage to 600 mg and then 400 mg. The study monitors patients closely to manage any side effects and ensure compliance with the dosing schedule. Throughout the study, participants will undergo regular assessments, including cytogenetic and molecular response evaluations at 6, 12, and 24 months. Researchers will track major cytogenetic response at 6 months as the primary outcome, with additional measures of overall survival and progression-free survival by 24 months. Safety and tolerability will also be monitored, with follow-up lasting up to two years to evaluate long-term effects and disease progression.

Researchers are evaluating the pharmacokinetics PK and safety of subcutaneous SC ublituximab in people with relapsing multiple sclerosis RMS. The study aims to compare how ublituximab is absorbed and tolerated when injected at different sites on the body and when administered using either a prefilled pen device or a syringe. This Phase 2 trial involves adult participants with RMS who meet specific neurological stability and disability criteria. Participants will receive ublituximab SC either by syringe at one of three injection sites or by randomized assignment to receive the drug with either a prefilled pen or a syringe. The study evaluates the relative bioavailability of ublituximab delivered by these two methods over a planned treatment period extending up to 120 weeks, with key assessments occurring up to 12 weeks and beyond. During the study, participants will undergo plasma concentration measurements of ublituximab at various time points to determine drug levels and steady state exposure. Safety will be monitored through tracking treatment-emergent adverse events throughout the study. Participant satisfaction with the SC administration method will also be assessed. This long-term study may involve multiple visits for drug administration, monitoring, and questionnaires, continuing for up to five years.

This research aims to assess the physical impact of Multiple Sclerosis MS from the participants perspective. It also provides participants continued access to the medication ocrelizumab while evaluating its safety and tolerability. The study is an open-label extension phase 3 trial sponsored by Hoffmann-La Roche, focusing on patients previously enrolled in related studies who currently lack local access to ocrelizumab treatment. Participants will receive ocrelizumab either as a 600 mg intravenous infusion or a 920 mg subcutaneous injection, following the dosing schedule established in their prior parent study. Treatment will continue until local access to the drug becomes available, if safety concerns arise, if the participant withdraws consent, or in the event of death. During the study, participants will be monitored for changes in physical functioning using patient-reported outcome measures over up to five years. Researchers will also track the number of participants receiving ocrelizumab and monitor adverse events, including serious or special interest events that may lead to discontinuation. Safety and tolerability assessments will continue throughout the study duration, which may last up to five years.