Kerpen

Researchers are evaluating the effectiveness of delgocitinib cream 20 mg/g applied twice daily compared to a cream vehicle in treating adults with mild to severe palmoplantar pustulosis (PPP). This phase 2a, double-blind, two-arm trial focuses on adults diagnosed with PPP, a condition characterized by persistent pustules on the palms and/or soles, lasting more than three months. The study aims to assess skin improvement using the PPP Area and Severity Index (PPPASI) and other clinical evaluations over 16 weeks. Participants will be randomly assigned to apply either delgocitinib cream or the cream vehicle twice daily during a 16-week treatment period. The study involves approximately 9 visits over about 18 weeks in total. The trial is designed to compare the two treatments' effects on PPP severity, with a thorough monitoring process throughout the study period. During the trial, participants will undergo clinical assessments including photographic evaluations to confirm PPP diagnosis, PPPASI scoring to measure skin improvement, and physician global assessments. Safety and treatment adherence will be closely monitored. The main outcome measure is the number of participants achieving at least a 75% improvement in PPPASI score from baseline at week 16. The study also includes safety checks and follow-up to ensure participant well-being throughout the trial.

Researchers are conducting a multinational clinical trial called LBL 2018 to study treatment approaches for children and adolescents newly diagnosed with lymphoblastic lymphoma. The trial aims to see if replacing prednisone with dexamethasone in induction therapy can reduce relapse involving the central nervous system (CNS) and if intensified treatment improves event-free survival in high-risk patients. Participants are grouped into high risk and standard risk categories based on disease characteristics to guide treatment and randomization. The study compares standard chemotherapy treatment using prednisone to an experimental approach using dexamethasone during induction. Patients in standard risk groups receive induction, consolidation, extra-compartment phases, reintensification (for some), and maintenance therapy over 24 months. High-risk patients can be randomized again after induction to receive either standard or intensified chemotherapy including additional PEG asparaginase and alternating high-risk courses. Patients with CNS involvement receive intensified intrathecal therapy and additional doses during maintenance without cranial irradiation. Participants undergo treatment phases lasting up to 24 months with follow-up for up to 7.25 years to monitor relapse rates and event-free survival. Evaluations include disease status, CNS involvement, and response to therapy. The trial collects pathology and genetic samples for risk stratification and monitors safety and treatment effects across multiple international centers. This comprehensive study seeks to improve outcomes while reducing CNS relapses in young patients with lymphoblastic lymphoma.

Researchers are evaluating the use of dordaviprone (ONC201) in patients with newly diagnosed H3 K27M-mutant diffuse glioma. This international, Phase 3, randomized, double-blind, placebo-controlled study aims to determine if dordaviprone treatment after standard frontline radiotherapy can extend overall survival and progression-free survival in this patient population. Participants must have histologically confirmed H3 K27M-mutant diffuse glioma and have completed frontline radiotherapy. Participants are assigned to receive either dordaviprone or a matching placebo. Those weighing 52.5 kg or more will receive 625 mg of dordaviprone (five 125-mg capsules) on dosing days, while those under 52.5 kg will receive a dose adjusted by body weight in 125-mg increments. The study compares the effects of dordaviprone treatment versus placebo after standard radiotherapy. The treatment dosing schedule and duration are based on the study protocol. During the study, participants will undergo brain MRI scans before and after radiotherapy, with imaging reviewed centrally. Researchers will monitor overall survival from randomization until death from any cause for up to approximately 44 months. Participants' performance status, corticosteroid and anti-seizure medication doses, and safety labs will be assessed. The study includes careful monitoring to evaluate the treatment's impact and safety over the follow-up period.

Researchers are evaluating the effectiveness and safety of a combination treatment using pembrolizumab and lenvatinib in women with vulvar cancer that has come back, persisted, spread, or is locally advanced and cannot be treated with surgery or radiation aimed at cure. This is a multicenter, open-label phase II study focusing on patients whose vulvar squamous cell carcinoma cannot be treated with salvage surgery or definitive chemoradiation. The study aims to measure the overall response rate within 24 weeks of treatment. Participants will receive pembrolizumab 400 mg every six weeks and lenvatinib 20 mg daily. The study does not include a comparison group and is designed to monitor the combined treatment's effects in this patient group. Archival or fresh tumor tissue samples will be collected for analysis, and treatment will continue according to the schedule unless safety or disease progression concerns arise. During the study, participants will be closely monitored through tumor assessments, physical exams, and laboratory tests to evaluate treatment response and safety. Researchers will track overall tumor response over 24 weeks and observe any side effects or adverse events. The study requires patients to have adequate organ function and performance status and includes ongoing safety follow-up throughout the treatment period.

Researchers are investigating whether combining lurbinectedin with doxorubicin as the first treatment for metastatic leiomyosarcoma (LMS) can extend the time patients live without their disease worsening compared to doxorubicin alone. This phase III trial focuses on patients with metastatic LMS who have not previously received systemic treatment for metastatic disease and aims to assess progression-free survival by an Independent Review Committee. Participants receive either the combination of lurbinectedin given by intravenous infusion plus doxorubicin administered as a short intravenous push or bolus, or doxorubicin alone as a single agent. The treatments are given as first-line therapy for metastatic LMS. Details about dosing schedules and treatment cycles are guided by standard protocols and label instructions. Throughout the study, participants will undergo regular assessments including disease evaluations using imaging based on RECIST criteria to measure tumor response. Researchers will monitor safety, blood counts, organ functions, and heart function with scans or echocardiography. Progression-free survival will be tracked up to about 41 months. Participants' adherence and health status will be closely followed during the study period to evaluate treatment outcomes and tolerability.