Prahran

This research aims to collect long-term safety and effectiveness data for participants treated with ibrutinib, a medicine used for various blood cancers and conditions including Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Waldenstrom Macroglobulinemia, and Chronic Graft Versus Host Disease. It also provides ongoing access to ibrutinib for participants who have completed previous ibrutinib studies, continue treatment, and benefit from it. This is an open-label Phase 3b study without formal hypothesis testing. Participants will continue their current ibrutinib dosing regimen from the prior study, taken orally once daily as capsules in doses of 560 mg, 420 mg, 280 mg, or 140 mg, around the same time each day. Treatment continues until the investigator decides the participant no longer benefits due to disease progression or side effects, the participant withdraws, alternative ibrutinib access becomes available, or the study ends. Participants not able to access ibrutinib elsewhere can keep receiving the single-agent ibrutinib until all transition or stop treatment, or until the study is stopped. During the study, safety is monitored throughout and summarized, and effectiveness may be analyzed together with previous study data. The main outcome measured is the number of participants experiencing any adverse events within 30 days after the last dose or until starting another cancer treatment. Participants will undergo assessments including pregnancy testing and investigator evaluations to ensure ongoing benefit and safety. The study duration depends on when participants stop treatment or transition to other access.

Mycobacterium abscessus (MABS) is a group of rapidly growing, multi-drug resistant bacteria that can cause serious lung infections, especially in people with underlying inflammatory lung conditions. These infections, called MABS pulmonary disease (MABS-PD), can lead to worsened lung function, increased healthcare needs, and reduced quality of life. The trial, called Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT), aims to find the best treatment plans to clear MABS infections while minimizing side effects and treatment burdens. It also seeks to develop biomarkers to help guide treatment decisions and measure disease severity. The trial uses an innovative platform design to test and improve different treatment combinations for both children and adults with MABS-PD. Treatments include various intravenous and oral antibiotics such as amikacin, tigecycline, imipenem, cefoxitin, azithromycin, clarithromycin, clofazimine, ethambutol, linezolid, co-trimoxazole, doxycycline, moxifloxacin, bedaquiline, and rifabutin. The study includes phases of intensive intravenous therapy followed by consolidation with oral and/or inhaled antibiotics. Different durations and combinations of therapy are tested, including short and prolonged intensive treatments and consolidation therapies with or without inhaled amikacin. Participants will be involved in the study for up to 62 weeks, depending on their treatment group. Throughout the study, researchers will collect respiratory samples to monitor bacterial clearance and evaluate tolerance to treatments using standardized criteria for side effects. Additional assessments include quality of life measures, gene expression, imaging, and antibiotic resistance studies. The trial also includes an observational cohort for participants not receiving active treatment, allowing transition to the intervention program if eligible. Safety and treatment response will be closely monitored during and after therapy.

Researchers are evaluating the safety, tolerability, and anti-cancer activity of S095035, a MAT2A inhibitor, alone or combined with TNG462, a PRMT5 inhibitor, in adults with advanced or metastatic solid tumors that have a specific genetic deletion called homozygous MTAP deletion. This first-in-human Phase 1/2, open-label, multicenter trial includes participants who have not responded to at least one prior treatment and have no available effective standard therapies. The study focuses on patients with measurable disease and excludes certain brain tumors and patients in China with specific types of glioblastoma. Participants receive S095035 orally every day in 28-day cycles, either alone or combined with TNG462 taken daily. The study has multiple arms based on tumor type and includes fresh or archival tumor biopsies depending on the phase and participant condition. Some participants will provide paired biopsies before and during treatment for research purposes. The trial involves dose expansion phases and includes specific procedures for pre-screening genetic deletions in tumor tissue. During the study, participants will be closely monitored for dose-limiting toxicities in the first 28-day cycle, adverse events, and serious adverse events for up to five years after the last dose. Researchers will assess objective response rates by measuring tumor changes throughout the study. Participants will undergo various evaluations including tissue biopsies, imaging, and safety follow-up visits. The total duration of involvement may extend to approximately five years for long-term safety and treatment effects monitoring.

Researchers are conducting an international, multi-center, open-label randomized controlled trial called TRICS-IV to compare two blood transfusion strategies in patients aged 18 to 65 years undergoing cardiac surgery with cardiopulmonary bypass. The study focuses on moderate to high-risk patients and aims to evaluate which transfusion threshold may lead to better outcomes after surgery. Participants will be assigned to one of two groups. The restrictive transfusion group will receive red blood cell transfusions only if their hemoglobin levels fall below 75 g/L during or after surgery. The liberal transfusion group will receive transfusions if their hemoglobin drops below 95 g/L during surgery or in the intensive care unit after surgery, or below 85 g/L on the ward. The study compares these two commonly used approaches to transfusion management. During the study, participants will be monitored for up to six months after surgery. Researchers will track a combined measure that includes death from any cause, heart attacks, new kidney failure requiring dialysis, or new strokes. Participants will be assessed through clinical follow-up to determine how these events relate to the transfusion strategy they received. This long-term monitoring will help evaluate the safety and outcomes of the different transfusion thresholds.