Sisli

Researchers are evaluating treatments for newly diagnosed multiple myeloma in patients who cannot undergo autologous stem cell transplantation. This Phase 3 study compares two drug combinations belantamab mafodotin with lenalidomide and dexamethasone BRd versus daratumumab with lenalidomide and dexamethasone DRd. The goal is to see if BRd extends progression-free survival and improves minimal residual disease negative status compared to DRd. Participants receive either BRd or DRd treatment, continuing until disease progression, death, unacceptable side effects, withdrawal, or study end. Both treatment arms involve the administration of lenalidomide and dexamethasone alongside either belantamab mafodotin or daratumumab. Treatment duration may last up to approximately seven years. During the study, participants will undergo regular assessments including monitoring disease progression, response to treatment, and side effects. Measurements include progression-free survival, overall survival, and the number achieving minimal residual disease negative status. Quality of life questionnaires and blood tests will also be conducted. Safety monitoring includes eye exams and tracking adverse events throughout the study duration.

Researchers are evaluating the effectiveness and safety of MB-CART2019.1 compared to standard treatments in adults with relapsed or refractory diffuse large B-cell lymphoma DLBCL who are not eligible for intensive chemotherapy and stem cell transplantation. The study is a pivotal Phase II randomized, multi-center, open-label trial with two parts Part I compares MB-CART2019.1 to standard therapy, while Part II evaluates MB-CART2019.1 alone in younger, fitter patients. MB-CART2019.1 is a genetically modified T-cell therapy designed to target malignant B cells in advanced blood cancers. Participants in Part I are randomly assigned to receive either a single infusion of MB-CART2019.1 following lymphodepleting chemotherapy or standard of care SoC therapy, which includes regimens like R-GemOx or BR plus polatuzumab vedotin. Patients undergo leukapheresis to collect T cells for MB-CART2019.1 production. Those in the SoC arm may later receive MB-CART2019.1 if certain disease progression criteria are met. Part II will enroll younger participants to receive MB-CART2019.1 alone after Part I enrollment completes. Participants will be involved in screening, treatment, and follow-up visits totaling about 55 weeks. Assessments include scans, laboratory tests, and evaluations of disease response and safety. Primary outcomes measure event-free survival in Part I and objective response rate in Part II, both up to 30 weeks after treatment. Secondary outcomes include progression-free survival, overall survival, and duration of response assessed up to nearly two years. Extended long-term follow-up beyond the active study period will be reported separately.

Researchers are conducting an observational study to screen adults aged 18 and over who visit hospital outpatient clinics in Turkey for malnutrition and sarcopenia risks. The study focuses on patients attending oncology, neurology, and geriatric clinics to better understand these conditions across diverse patient groups. This non-interventional, cross-sectional design means participants are observed without receiving experimental treatments. Participants are screened once during their outpatient visit without any study treatments or interventions. The study collects information on malnutrition risk, sarcopenia risk, body mass index, calf circumference, hand grip strength, biochemical parameters, healthcare use, and nutrition treatments. Data is gathered on the screening day only. During the study visit, researchers will assess physical and biochemical measures to evaluate nutrition and muscle health. Participants provide informed consent before any assessments. The study measures malnutrition and sarcopenia risks as primary outcomes on the first day and includes several secondary measures related to body composition and healthcare use. The study will continue enrolling participants until April 2027.

Researchers are evaluating the efficacy and safety of Adagrasib alone and in combination with pembrolizumab for patients with advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study includes a Phase 2 portion that assesses these treatments in patients with various PD-L1 tumor proportion scores TPS and a Phase 3 portion that compares Adagrasib plus pembrolizumab to pembrolizumab alone in patients with higher PD-L1 TPS 50%. The goal is to understand how these treatments work as first-line therapy in this patient population. Treatment involves Adagrasib administered orally twice daily BID either alone or combined with pembrolizumab, which is given intravenously at 200 mg every three weeks. Phase 2 includes three cohorts based on PD-L1 status and treatment type, while Phase 3 randomly assigns patients to receive either the combination or pembrolizumab alone. Patients with unresectable or metastatic squamous or nonsquamous NSCLC are included, with specific brain metastases criteria for Phase 3 participants. Participants will be monitored over periods of up to 22 months in Phase 2 and 36 months in Phase 3. Assessments include measuring treatment efficacy, safety, pharmacokinetics, quality of life, and tumor response using RECIST 1.1 criteria. Regular evaluations involve imaging, clinical exams, and patient-reported outcomes. The study aims to provide detailed information on treatment tolerability and effectiveness during and after therapy.

Researchers are evaluating the GRADY prediction models, which use machine learning to estimate the risk of gram-negative bacteremia and sepsis in intensive care unit ICU patients. Sepsis is a serious condition with high mortality that needs early diagnosis and treatment. Current methods like blood cultures take time, and existing scoring systems such as SOFA, SIRS, and NEWS2 may not detect sepsis early enough. This study aims to compare the GRADY models with these standard scoring systems to assess their ability to provide earlier and more accurate risk detection and support timely clinical decisions in critical care. The study will prospectively validate the GRADY models by using routinely collected vital signs and laboratory data from ICU patients. These models will be assessed for their diagnostic accuracy and clinical usefulness compared to existing scores such as SOFA, SIRS, and NEWS2. The study also plans to calculate Pitt Bacteremia Scores to explore relationships with GRADYs risk classifications. This observational study will include ICU patients who have had blood cultures taken as part of their routine care. Participants will be adult ICU patients monitored for at least 48 hours, with blood cultures obtained during their stay. Data collection involves reviewing routine clinical and laboratory information and calculating various scores at admission. The main outcome is detecting gram-negative bacteremia within 28 days. Secondary outcomes include measuring SOFA, SIRS, and NEWS2 scores at admission. The study aims to evaluate the models ability to identify high-risk patients early, potentially improving treatment timing and outcomes in ICU care. The study will run until early 2026.

Multiple myeloma is a cancer affecting plasma cells in the bones and bone marrow, causing bone pain, fractures, infections, weak bones, and kidney failure. This study is evaluating the investigational drug etentamig compared to standard available therapies in adults with relapsed or refractory multiple myeloma. The study aims to understand changes in disease symptoms and treatment effects over time in this population. Participants are randomly assigned to one of two groups Arm A receives etentamig as an intravenous infusion given in 28-day cycles, and Arm B receives standard available therapies chosen by the investigator based on local guidelines. The study will last about 3.5 years, with treatments and monitoring continuing throughout this period. Participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure outcomes such as progression-free survival, response rates, overall survival, symptom changes, and quality of life using questionnaires and clinical tests. The study includes careful safety monitoring and may involve more treatment visits than standard care.

Researchers are evaluating treatments for patients newly diagnosed with Peripheral T-Cell Lymphoma PTCL in a phase 3 study. The trial aims to find the best dose of two drugs, Belinostat and Pralatrexate, combined with chemotherapy regimens CHOP or COP, focusing on safety and effectiveness. The study compares two experimental combinations against the standard CHOP regimen to see which improves progression-free survival in PTCL patients. The study has two parts. Part 1 tests two dose levels of Belinostat with CHOP and Pralatrexate with COP in five groups to determine the safest and most suitable doses. Part 2 randomizes patients into three groups Belinostat plus CHOP, Pralatrexate plus COP, and CHOP alone, with treatments given in up to six cycles spaced 21 days apart. Belinostat and Pralatrexate are administered intravenously with specific schedules alongside chemotherapy drugs. The study includes detailed dosing and administration plans for each group. Participants undergo up to 28 days of screening, followed by treatment cycles lasting about 18 weeks. Tumor assessments occur regularly during treatment and for up to three years after, with follow-up visits every six months until five years. Researchers collect data on progression-free survival, overall survival, and safety. Long-term monitoring includes phone follow-ups to track outcomes. Participants are closely monitored through clinical evaluations, laboratory tests, and imaging throughout the study.