Talence

Researchers are evaluating Enzomenib DSP-5336, an oral drug, in patients with various types of acute leukemia, including relapsed or refractory acute myeloid leukemia AML, acute lymphocytic leukemia ALL, and acute leukemia of ambiguous lineage. The study also includes patients with high-risk myelodysplastic syndromes MDS and relapsed multiple myeloma MM in selected sites. This phase 12 trial aims to assess the safety, pharmacokinetics, pharmacodynamics, and clinical activity of DSP-5336 alone or combined with standard AML treatments, particularly in patients with specific genetic mutations like MLL rearrangement or NPM1 mutation. The study involves dose escalation and dose expansion of DSP-5336 administered orally. Participants may receive DSP-5336 alone or combined with standard AML regimens such as venetoclax plus azacitidine or intensive chemotherapy with cytarabine and daunorubicin 73. Different study arms include patients with or without certain medications like CYP3A4 inhibitor azoles, and those with specific genetic profiles. The trial evaluates recommended phase 2 doses for various patient groups and combination treatments. Participants will undergo assessments including monitoring for adverse events within 30 days after the last dose and evaluation of clinical responses approximately six months after treatment begins. Researchers will collect blood and bone marrow samples for genomic analysis and track drug levels in the body. Safety labs, ECGs, physical exams, and patient questionnaires will be performed throughout the study. The trial includes long-term follow-up of overall survival up to two years after treatment ends, with visits and tests scheduled to monitor health and treatment effects.

Researchers are studying the safety and tolerability of elritercept in adults with anemia linked to very low, low, or intermediate risk Myelodysplastic Syndromes MDS. The study aims to understand how elritercept affects red blood cell production and the progression of MDS, including how well participants tolerate different doses of the drug. This phase 2, open-label trial focuses on anemia associated with lower-risk MDS and evaluates the impact on healthy red blood cell production. Participants receive elritercept as a subcutaneous injection every 4 weeks, with doses ranging from 0.75 mgkg to 5.0 mgkg during an initial period of up to 4 cycles each 28 days. Following this, participants continue treatment with elritercept every 4 weeks for up to 24 cycles, with dose adjustments based on individual response. Different cohorts include participants with or without ring sideroblasts, those requiring red blood cell transfusions, and those with chronic myelomonocytic leukemia CMML. Some participants may enter a long-term extension phase receiving elritercept every 4 weeks for up to about 10 years. During the study, participants undergo regular monitoring including blood tests, assessments of red blood cell parameters, and tracking of adverse events and disease progression. Researchers measure treatment-emergent adverse events, progression to higher-risk MDS or acute leukemia, transfusion independence, and hematologic improvements over up to 11 years. The study includes follow-ups to evaluate the duration and timing of responses, safety, and overall effects on anemia and MDS progression.

Researchers are evaluating an experimental drug called REGN5837 in combination with another drug, odronextamab, for adults with relapsed or refractory aggressive B-cell Non-Hodgkin Lymphomas B-NHLs. The study aims to find a safe dose of REGN5837 when combined with odronextamab and then assess how well this combination works. Additional questions include side effects, drug levels in the blood, and whether the body develops antibodies that might affect the drugs action. The study has two parts. The first part involves dose escalation to determine a safe dose of REGN5837 combined with odronextamab. The second part uses the safe dose found to evaluate the treatments effectiveness. Both drugs are administered according to the study protocol. The study does not use randomization or masking. Participants will be monitored for side effects and adverse events for up to approximately five years. Researchers will measure drug concentrations in the blood, antibody responses, and cancer response using the Lugano Classification. Tumor biopsies may be required during the dose expansion phase. The study includes regular assessments and follows participants long term to evaluate treatment safety and outcomes.

Researchers are collecting clinical data to evaluate the ongoing safety and performance of commercial Biosense Webster Inc. BWI medical devices used during routine cardiac arrhythmia mapping and ablation procedures. This observational study aims to confirm the safety and effectiveness of these devices after they have been approved for market use, expanding knowledge on their role in treating cardiac arrhythmias such as atrial fibrillation, supraventricular tachycardia, and ventricular tachycardia. Participants diagnosed with cardiac arrhythmias and scheduled for an ablation procedure using BWI therapeutic catheters, including Varipulse and Dual Energy THERMOCOOL SMARTTOUCH SF catheters, will be observed during their routine clinical treatment. The study does not introduce additional interventions but monitors standard procedures using these commercial devices. Sub-studies involve participants treated specifically with the Varipulse or Dual Energy catheters. During the study, participants will be monitored for adverse events related to the devices and procedures within 7 days post-procedure and up to one year for serious or non-serious adverse events. Effectiveness measures include arrhythmia isolation or elimination and freedom from arrhythmia episodes over time. Data collection aligns with routine care standards, including follow-up visits up to 365 days to assess outcomes such as arrhythmia recurrence, repeated ablations, hospitalizations, and mortality. The study duration extends through December 2037.

Researchers are studying advanced non-small cell lung cancer NSCLC with ALK gene rearrangement treated with next-generation tyrosine kinase inhibitors TKIs as first-line therapy. This prospective study, part of the national EXPLORE ALK cohort, aims to understand the biological characteristics and resistance mechanisms of this cancer type. It involves patients with stage IIIB or IV NSCLC who are not eligible for curative locoregional treatment and have confirmed ALK rearrangement. The study collects tumor tissue samples at diagnosis and at disease progression, if available, to analyze ALK fusion partners, variants, and co-mutations using RNA sequencing. Blood samples are taken at diagnosis, first tumor evaluation, and disease progression to analyze circulating tumor DNA ctDNA with next-generation sequencing. Treatments studied include alectinib, brigatinib, lorlatinib, and entrectinib, either marketed or under early access programs. Participants provide blood samples and allow use of tumor tissue for centralized biological analyses. Researchers measure progression-free survival up to 72 months as the primary outcome, along with overall survival, response rates, duration of response, ctDNA clearance, and resistance mechanisms associated with treatment and ALK fusion partners. The study involves regular evaluations over several years to monitor treatment outcomes and biological changes.

Primary Sjf6grens syndrome pSS is an autoimmune disease primarily affecting exocrine glands, causing dryness, joint pain, and fatigue, with some patients experiencing more severe systemic symptoms and higher risk of lymphoma. This trial aims to evaluate a new combined treatment targeting both B- and T-cells using a novel clinical endpoint called STAR, designed to better measure treatment response in pSS patients. The study involves two patient groups based on disease activity and symptoms. Each group receives one of three treatments daily for 24 weeks placebo pills, a combination of Leflunomide and hydroxychloroquine with placebo Mycophenolate mofetil, or Mycophenolate mofetil combined with hydroxychloroquine and placebo Leflunomide. The trial is randomized and triple-blinded to fairly compare these combinations targeting immune cells. Participants will be monitored over 24 weeks with assessments focusing on response measured by the STAR tool. Researchers will evaluate how many patients achieve a treatment response compared to placebo. Safety and disease activity will be tracked through clinical evaluations and laboratory tests. The study started in 2022 and aims to finish by 2025, with ongoing monitoring throughout the treatment period.

Diabetic foot ulcer DFU is a common and serious complication in people with diabetes, often leading to lower-limb amputation and linked to decreased quality of life and increased health care costs. This research aims to better understand why patients with DFU have a higher risk of premature death, exploring factors beyond cardiovascular disease such as inflammation, infections, and cancers. The study is a prospective, observational, multi-center cohort conducted in France. Adults with diabetes and DFU will be followed for up to 5 years to measure outcomes including mortality rates, causes of death, and prognostic factors. The study will include a 3-year enrollment period starting in 2020. Researchers will also assess changes in health-related quality of life and the economic burden of DFU using healthcare claims data. Participants will be monitored regularly over 5 years or until death. Researchers will collect data on survival without active or recurrent DFU, major limb and vascular events, and overall health status. The study will provide important data on the course of DFU and its impact on patients lives and health care systems.

Colorectal cancer is a leading cause of cancer-related death, with many patients developing liver metastases that are often difficult to remove surgically. This trial focuses on first-line treatment for patients with metastatic colorectal cancer limited to the liver, aiming to evaluate the effectiveness of combining systemic chemotherapy, targeted therapies, and intra-arterial oxaliplatin chemotherapy. The study seeks to improve tumor response rates, progression-free survival, and overall survival in this patient group. Participants will receive one of four treatment regimens involving combinations of oxaliplatin administered either intra-arterially or intravenously, along with folinic acid, 5-fluorouracil 5-FU, irinotecan, and targeted therapies such as panitumumab or bevacizumab depending on RAS mutation status. Treatment cycles occur every 15 days, with dosing tailored to each arm including variations in drug delivery methods and combinations. The trial includes both experimental and reference treatment arms to compare outcomes. Throughout the study, participants will be monitored for progression-free survival up to 24 months after randomization. Assessments include measuring tumor response by RECIST criteria and evaluating liver metastases. Safety and tolerability will be tracked through laboratory tests and clinical evaluations, while participants eligibility and health status will be closely followed. The study duration extends up to 2028, with ongoing data collection to assess long-term outcomes and treatment effects.