Barnaul

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 studying aggressive high-volume metastatic hormone-sensitive prostate cancer mHSPC in male patients in the Russian Federation. This observational study focuses on treatment patterns and the evaluation of homologous recombination repair mutations HRRm in circulating tumor DNA ctDNA. The study aims to better understand demographic and clinical characteristics along with how patients with different HRR gene statuses are treated. The study enrolls about 400 male patients with high-aggressive Gleason 8-10 and high-volume mHSPC who have known tumor HRRm status from routine tumor samples. No additional procedures beyond routine clinical care are performed. Data are collected during two visits a baseline visit where medical history and treatment approaches since diagnosis are recorded, and a final visit at disease progression or after about 12 months to gather follow-up treatment and progression information. Blood samples for ctDNA and HRRm testing are collected from routine blood draws and analyzed centrally. Participants contribute data through medical record reviews and, if needed, patient interviews. Researchers collect information on treatments received, disease progression, lab tests, and mutation presence. The study evaluates various outcomes including treatment proportions, therapy durations, progression times, and mutation rates over 36 months. Data are entered into electronic forms, and follow-up may occur by phone if in-person visits are not possible. The total study duration is about 38 months or until all data are collected.

Researchers are conducting a national, multi-center, prospective study to collect real-world data on patients in the Russian Federation with advanced and aggressive endometrial cancer, specifically stage III-IV disease. The study focuses on molecular profiling markers such as POLE mutations, dMMRpMMR, p53 abnormalities, HER2 expression, and PD-L1 status, alongside demographic and clinical characteristics. It aims to understand first-line postoperative treatment approaches in these patients. The study involves no additional procedures beyond routine clinical practice. Patients provide archival tumor tissue samples obtained from biopsy or post-operative formalin-fixed paraffin-embedded FFPE blocks for molecular testing. Testing uses immunohistochemistry IHC for certain markers and next-generation sequencing NGS or polymerase chain reaction PCR for POLE mutations. Data will be collected at two visits a baseline visit to gather clinical and demographic information and tissue testing results, and a final visit 6 months later or at disease progression to collect follow-up treatment and progression data. Participants data and outcomes will be recorded in an electronic case report form. The study measures include rates of positive molecular markers and various clinical and treatment-related outcomes over 24 to 33 months. Approximately 500 patients will be enrolled across about 30 sites. The overall study duration is about 27 months or until data collection for all patients is complete.

Researchers are evaluating the effectiveness, safety, how the body processes, and immune response to BCD-236 combined with chemotherapy in women with relapsed or metastatic triple negative breast cancer TNBC who have received previous treatments. This is a Phase 2 study that compares BCD-236 plus chemotherapy versus chemotherapy alone in patients whose cancer has returned or progressed after earlier therapies. Participants will be randomly assigned to one of two groups one receiving BCD-236 by intravenous infusion plus chemotherapy chosen by the investigator, and the other receiving chemotherapy alone. Treatment continues until the cancer worsens, side effects become intolerable, or the study ends. During the study, participants will undergo regular assessments including tumor measurements and health evaluations to monitor response and side effects. The main outcome measured is the overall response rate at 24 weeks, with secondary outcomes including progression-free survival, overall survival, disease control rate, time to response, and duration of response assessed at various times up to 102 weeks. Participants will be monitored closely throughout their treatment and follow-up periods.

Researchers are conducting an observational multicenter cross-sectional study involving 5,000 adult patients in Russia with uncontrolled severe asthma SA who are receiving standard care treatments except biologics. The study aims to describe the characteristics of these patients across about 50 outpatient centers in 50 regions of Russia, addressing the lack of unified data on severe asthma epidemiology, complications, comorbidities, and treatment patterns in the country. Participants will have a single study visit where demographic and clinical data will be collected without any additional interventions or changes to their routine care. The study will gather information on treatment patterns, including the use of oral corticosteroids and various medication classes, and analyze clinical and demographic features such as age at diagnosis, gender distribution, body mass index, lifestyle factors, and presence of comorbidities. During the study, researchers will review medical records and follow-up data from the prior 52 weeks to assess treatment changes, exacerbations, healthcare resource use, and lung function parameters. No extra diagnostic or therapeutic procedures will be performed beyond standard practice. The study will run from June 2024 to June 2027, aiming to provide detailed epidemiological insights into uncontrolled severe asthma in the Russian adult population.

Researchers are evaluating the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of the study drug BCD-261 in patients with moderate to severe active Crohns Disease. This study involves adult men and women aged 18 to 75 years who have had an inadequate response to previous treatments such as glucocorticoids, immunosuppressants, or biologics. The trial is designed to better understand the dose-response relationship of BCD-261 compared to a placebo in this patient group. Participants are randomly assigned to one of five groups receiving different dosing regimens of BCD-261 or placebo. Four groups receive varying doses of BCD-261 low, medium, high during induction weeks 0-12 and maintenance phases, with some groups transitioning between doses. The fifth group receives placebo until the primary endpoint assessment at week 14, after which they switch to the medium dose of BCD-261. During the study, participants will be closely monitored for clinical remission and endoscopic response at week 14, with additional remission assessments at week 24. The study includes comprehensive evaluations such as safety monitoring and pharmacokinetic and pharmacodynamic assessments. Participants will be involved throughout the induction and maintenance periods with scheduled visits and assessments to track treatment effects and safety over time.

Researchers are evaluating the use of the Efferon LPS device for hemoadsorption during and shortly after cardiac surgery with cardiopulmonary bypass CPB. The study aims to assess whether this treatment can reduce the occurrence and severity of multiple organ dysfunction syndrome MODS, including acute kidney injury, which is a common and serious complication after cardiac surgery. The trial focuses on adults undergoing elective or emergency cardiac surgery and addresses complications linked to endotoxemia and ischemia-reperfusion injury. Participants are randomly assigned to one of two groups one receives standard cardiac surgery care with CPB without hemoadsorption, and the other receives standard care plus hemoadsorption using the Efferon LPS device. The hemoadsorption is performed twice for those in the treatment grouponce during the CPB phase of surgery for the duration of CPB, and again within 24 hours after surgery for at least 6 hours. Throughout the study, participants will be monitored for multiple outcomes including organ function assessed by the Sequential Organ Failure Assessment SOFA score over 1 to 7 days, time without vasopressors, duration of renal replacement therapy and mechanical ventilation, length of ICU stay, 28-day mortality, and incidence of postoperative complications. Assessments and safety monitoring will occur regularly during the first 28 days after surgery, helping researchers understand the impact of hemoadsorption on patient recovery and organ function.

The trial investigates the safety and effectiveness of olokizumab compared to a placebo in adults with progressive fibrosing interstitial lung diseases ILD. This phase 23 study uses a double-blind, parallel-group adaptive design to better understand treatment impacts on lung function over time. Participants have progressive fibrosing ILD confirmed by imaging and lung function tests, with disease progression documented within the prior months or years. Participants will be randomly assigned to receive either subcutaneous injections of olokizumab 64 mg or placebo every four weeks during a 48-week treatment period. The study includes a screening period lasting four weeks, followed by a treatment period of 48 weeks, and then a follow-up period of 24 weeks with visits scheduled at 4, 12, and 24 weeks post-treatment. The total duration of participation is approximately 76 weeks. Throughout the study, patients will undergo lung function tests including forced vital capacity FVC and diffusion capacity for carbon monoxide DLCO, as well as imaging assessments to evaluate lung fibrosis. Researchers will monitor symptoms, lung function changes, and quality of life measures using dyspnea scores and health questionnaires. Safety will be closely observed during treatment and follow-up visits, with the main outcome focused on changes in FVC over 48 weeks.

This research evaluates the long-term safety and effectiveness of pembrolizumab in participants with advanced tumors or hematologic malignancies who have previously taken part in Merck pembrolizumab-based studies. This phase 3 extension study includes participants currently on treatment or in follow-up from parent trials. The study has three phases based on participants prior treatment status First Course Phase, Survival Follow-up Phase, and Second Course Phase, allowing continuation or observation depending on prior participation. Participants receive pembrolizumab alone or combined with other treatments such as standard of care therapies, lenvatinib, olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Dosing schedules vary by phase and regimen, including intravenous infusions of pembrolizumab every 3 or 6 weeks, oral lenvatinib capsules daily, oral olaparib tablets twice daily, and other biologics administered intravenously or subcutaneously. The study allows up to 35 doses in the First Course Phase and fewer doses in the Second Course Phase, with treatment durations adjusted for crossover eligibility and combination therapies. Participants are monitored through regular treatment visits involving drug administration and follow-up assessments. Researchers evaluate overall survival up to approximately 10 years, along with progression-free survival, event-free survival, and adverse events including serious and clinically significant side effects. The study includes ongoing safety monitoring up to around 40 months post-treatment. Participants remain under observation for long-term outcomes and potential treatment effects for many years after enrollment.

Researchers are evaluating the safety and effectiveness of a single bolus dose of non-immunogenic recombinant staphylokinase compared to a placebo in adults with intermediate high-risk pulmonary embolism PE who have stable blood pressure. This phase 3 trial addresses the need for safer thrombolytic treatments in patients who are at risk but do not have shock or low blood pressure, as previous thrombolytics had risks like hemorrhagic stroke. The study aims to improve outcomes while minimizing adverse effects in this patient group. Participants receive either a quick intravenous injection of non-immunogenic recombinant staphylokinase or a matching placebo. The staphylokinase dose is 15 mg given as a single bolus over 10-15 seconds regardless of body weight. The placebo group receives a similar injection with saline solution. This treatment period is followed by monitoring to compare the effects and safety between the two groups. During the study, participants will be assessed for clinical outcomes including death, hemodynamic collapse, and recurrent pulmonary embolism within 30 days. Additional measures include heart function and lung pressure evaluations within 24 hours and 30 days, along with monitoring for bleeding events and other adverse effects. The trial lasts for 30 days after treatment with ongoing safety checks, and participant consent and adherence to contraceptive use are required throughout the study period.