Sochi

This research aims to gather long-term safety and effectiveness information for people treated with ibrutinib, a medicine taken by mouth that blocks a specific enzyme called brutons tyrosine kinase. The study focuses on participants who previously took part in ibrutinib studies that have finished and are still receiving ibrutinib treatment, continuing to benefit from it. It is an open-label study, meaning both participants and researchers know the treatment being given. Participants will continue taking ibrutinib capsules daily at the dose they were given in their prior study until the doctor decides the treatment is no longer helpful due to disease progression or side effects, the participant chooses to stop, other treatment options become available, or the study ends. Safety will be monitored throughout, and effectiveness data may be combined with previous study results. No formal testing of hypotheses is planned in this extension. During the study, participants will be regularly monitored for safety and disease status. The main outcome is the number of participants experiencing side effects within 30 days after the last ibrutinib dose or before starting another cancer therapy. Participants may continue treatment until alternative access to ibrutinib is arranged or the study ends, which is planned for December 2029. Researchers will collect ongoing data to understand the long-term effects of ibrutinib treatment.

Researchers are evaluating the safety and effectiveness of BCD-248 combined with daratumumab compared to a combination of daratumumab, pomalidomide, and dexamethasone for treating adults with relapsed or refractory multiple myeloma. This study focuses on participants aged 18 and older who have measurable multiple myeloma and have received previous treatments including a proteasome inhibitor and lenalidomide, specifically those who are refractory to lenalidomide or have had disease progression after prior therapies. Participants will receive either BCD-248 administered under the skin with daratumumab given intravenously, or the combination of daratumumab intravenously with pomalidomide and dexamethasone taken orally. The study is randomized without masking, comparing these two treatment groups in parallel. The intervention period includes monitoring for up to 36 months to assess disease progression and response, with additional long-term evaluations lasting up to 5 years. During the trial, participants will undergo assessments including measuring minimal residual disease using flow cytometry at 12 months, and monitoring progression-free survival per established criteria. Other evaluations include response rates, survival, immune markers, and adverse events over several years. Safety and treatment effects will be closely followed with regular clinical visits and laboratory tests throughout the study duration, which extends until October 2032.

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.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

Researchers are evaluating the efficacy and safety of BCD-248 as a treatment for patients with relapsed or refractory multiple myeloma, a condition where the disease has returned or is resistant to previous therapies. This open-label phase 2 clinical study aims to assess the overall response rate and other important outcomes in this patient population. The study is sponsored by Biocad and focuses on patients who have received multiple prior treatments including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 therapy. Participants will receive BCD-248 administered subcutaneously. The study monitors various outcomes including overall response rate up to 24 weeks and progression-free survival up to 104 weeks, among others, over a total duration extending to about 3.7 years for some measures. Pharmacokinetic parameters like Cmax, Cmin, AUC0-t, and Ctrough will be tracked shortly after administration and up to 6 months. Additional assessments include measurement of soluble BCMA levels and the presence of binding and neutralizing antibodies. During the study, participants will undergo regular evaluations including disease assessments based on International Myeloma Working Group criteria, safety monitoring for adverse events, and laboratory tests. Long-term follow-up will include evaluation of response duration, time to response and progression, and overall survival. The study started in December 2024 and is expected to continue until July 2028, providing extended observation for participant outcomes and safety.

Researchers are investigating the use of lisaftoclax combined with BTK inhibitors in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma CLLSLL who have previously been treated with BTK inhibitors. This global, open-label, phase III study aims to evaluate the effectiveness and safety of this combination compared to BTK inhibitor alone in patients who have been on BTK inhibitor monotherapy for at least 12 months. About 440 participants will be randomly assigned to one of two groups one will receive lisaftoclax together with a BTK inhibitor, and the other will receive only a BTK inhibitor. The study uses a parallel design where participants are allocated equally to each treatment arm to compare outcomes clearly. Both treatments are administered under medical supervision, and the study is open-label, meaning both the researchers and participants know which treatment is given. Participants will be assessed regularly over the course of the study, with evaluations including disease progression measured at 12 months and overall survival also tracked at 12 months. Eligibility screening includes assessments of performance status, bone marrow, kidney, and liver function, as well as consent to follow the study schedule. The research team monitors safety and treatment effects throughout the trial, which is expected to complete by late 2027.

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 effectiveness of adjuvant ribociclib combined with hormone therapy using aromatase inhibitors with or without GnRH agonists in patients with hormone receptor-positive HR HER2-negative stage II-III breast cancer. This observational study includes two groups a prospective cohort receiving ribociclib plus aromatase inhibitors, and a retrospective cohort treated with aromatase inhibitor monotherapy. The study aims to analyze outcomes based on tumor grade, lymph node involvement, and hormone therapy response in real-world clinical practice in Russia. Participants in the prospective group receive ribociclib along with aromatase inhibitors GnRH agonists, while the retrospective group includes patients treated with aromatase inhibitor monotherapy. Data collection includes both primary prospective data and secondary retrospective data from medical records. The study does not involve experimental treatment assignments but observes existing treatment patterns and outcomes. Participants will be monitored over several years with assessments at months 36, 48, and 60 to evaluate invasive breast cancer-free survival and other related outcomes. Quality of life questionnaires and safety data including adverse events are collected at multiple time points up to 60 months. The study involves continuous data review to assess treatment adherence, disease recurrence, and patient well-being throughout the observation period.

Researchers are evaluating the efficacy and safety of Dimephosphon4 in patients who have experienced an acute ischemic stroke. This multicenter, randomized, double-blind, placebo-controlled study focuses on adults aged 35 to 80 with verified hemispheric ischemic stroke confirmed by CT or MRI, and neurological scores between 5 and 15 on the NIH Stroke Scale. The trial aims to assess improvements in stroke outcomes using several clinical scales including the Modified Rankin Scale, NIH Stroke Scale, Mini-Mental State Examination, Montreal Cognitive Assessment, and EuroQol 5-Dimensions. Participants are randomly assigned to one of two groups one receiving Dimephosphon4 and the other a placebo. In both groups, from days 1 to 3, the assigned treatment is given as an intravenous infusion three times daily with at least 5 hours between doses. From days 4 to 14, the treatment is administered as an intravenous bolus, also three times daily. The dosing involves 2 grams of the study drug or placebo diluted appropriately for each administration. During the study, participants undergo a screening period lasting up to 48 hours, followed by treatment visits on days 1 through 14, with follow-up assessments up to day 90. Researchers will monitor clinical outcomes and neurological function using established scales at multiple time points, including days 8, 15, 30, and 90. Safety and mortality will also be tracked. The total duration of participation spans from initial screening through the last follow-up visit at day 90.