Amarillo

Researchers are evaluating treatments for germinal center B-cell-like diffuse large B-cell lymphoma GCB DLBCL, a fast-growing blood cancer affecting immature B-cells. The study compares two treatment combinations to see if more people respond to zilovertamab vedotin MK-2140 plus R-CHP versus polatuzumab vedotin plus R-CHP. This Phase 2 trial aims to assess the effectiveness and safety of these regimens in participants with newly diagnosed GCB DLBCL. Participants receive either zilovertamab vedotin along with rituximab, cyclophosphamide, doxorubicin, and prednisone R-CHP, or polatuzumab vedotin combined with R-CHP. Treatments are given by intravenous infusion on Day 1 of each 3-week cycle for up to 6 cycles, approximately 4 months, with prednisone or prednisolone taken orally for 5 days of each cycle. For participants with high-risk DLBCL, up to 2 additional cycles of rituximab or biosimilar are given. During the study, participants are monitored for response to treatment using Lugano Response Criteria, with follow-up lasting up to about 31 months for the primary outcome. Secondary outcomes include progression-free survival, overall survival, event-free survival, duration of complete response, adverse events, and quality of life assessments. Safety and health status are regularly checked through exams, lab tests, and questionnaires over several years, with total study participation extending up to 7 years.

Researchers are exploring new treatment options for neovascular age-related macular degeneration NVAMD, a condition affecting the eyes. This trial aims to compare a new medicine called tiespectus also known as MK-8748 or EYE201 with the standard treatment aflibercept to see if tiespectus works as well in treating NVAMD. The study includes adults aged 50 and older who have not previously received treatment for this condition. Participants will be randomly assigned to one of three groups tiespectus low dose, tiespectus high dose, or aflibercept. Those in the tiespectus groups will receive three initial injections every 4 weeks, followed by injections every 8 weeks up to week 48. After week 48, treatment will continue at intervals based on individual response until week 92. The aflibercept group will receive three initial injections followed by injections every 8 weeks until week 92. During the study, participants will have their vision tested using the Best-Corrected Visual Acuity BCVA score and their eye structure examined with imaging techniques. Researchers will monitor changes in vision over one year and track any side effects up to approximately 96 weeks. Participants will attend regular visits for treatment and assessments throughout the study period lasting about 92 weeks.

This research investigates intravitreal EYE103 in adults with neovascular age-related macular degeneration NVAMD or macular edema caused by branch retinal vein occlusion BRVO. The trial is randomized and dose-masked, including four different patient groups to study different doses and combinations of EYE103, aiming to assess its effects in these eye conditions. Participants are divided into four cohorts treatment-naive NVAMD, incomplete responders IR with NVAMD as monotherapy, IR NVAMD combined with aflibercept, and treatment-naive BRVO. Each cohort randomly receives either a low or high dose of EYE103 via intravitreal injection. All receive three injections spaced 4 weeks apart the IR NVAMD combination group also receives aflibercept on Day 1. Assessments occur at each injection visit and some groups return 2 weeks post-injection for extra evaluations. During the 12-week study, participants undergo safety and efficacy assessments including vision tests using ETDRS charts, slit-lamp exams, fundoscopy, and imaging with spectral domain optical coherence tomography SD-OCT to measure retinal thickness. The studys main measure is the change in best-corrected visual acuity at Week 12. The trial also monitors retinal thickness and vision changes throughout. The Week 12 visit marks the studys end for all participants.

Researchers are studying the use of unlicensed cryopreserved cord blood units CBUs for transplantation in both children and adults with blood cancers and other related disorders. This observational study involves patients with hematologic malignancies and various inherited and acquired disorders affecting the blood and immune system. The main goal is to monitor how well neutrophil recovery occurs after transplantation using these unlicensed CBUs in multiple institutions. Participants receive unlicensed cryopreserved CBUs as part of their transplant treatment. The study includes patients of any age receiving these CBUs for approved indications. The protocol focuses on the access and distribution of these unlicensed units rather than a specific treatment intervention. The study gathers data from recipients who receive these CBUs, tracking outcomes after transplantation. Participants are monitored for neutrophil recovery at 60 and 100 days after transplant, defined by a neutrophil count of at least 500mm3. Researchers also collect information on infection transmission, infusion reactions, survival rates at one year, and incidence of acute and chronic graft versus host disease. Platelet recovery is also evaluated. Safety and efficacy outcomes are followed over time to better understand the effects of unlicensed CBUs in this patient population.

Researchers are evaluating zanidatamab for treating adults with previously treated solid tumors that overexpress the HER2 protein at a high level IHC 3. This Phase 2 study focuses on participants whose tumors have progressed after at least one prior systemic treatment and who have no other confirmed beneficial treatment options. The study excludes certain cancers like biliary tract cancer and considers prior HER2 therapy differently across tumor cohorts. Participants receive zanidatamab through intravenous infusion. The study includes a single treatment group with no placebo comparison. Treatment continues as per protocol with monitoring for responses and safety. The study collects tumor samples centrally to confirm HER2 status and requires measurable disease for evaluation. Various cohorts have specific prior treatment requirements. During the study, participants undergo assessments including tumor response evaluation by independent review and investigators using standard criteria RECIST 1.1. The trial monitors treatment safety, side effects, drug levels in the blood, and immune reactions to the drug. Participants will be followed for up to 2.5 years for response and safety, and overall survival is tracked for up to 3.5 years, with regular visits to assess health status and treatment effects.

Researchers are studying UGN-104, a new formulation of UGN-101 also known as JELMYTO, to evaluate its effectiveness and safety in treating patients with low-grade upper tract urothelial cancer LG-UTUC. This phase 3, single-arm study focuses on patients with this specific type of cancer affecting the upper urinary tract, aiming to assess how well the treatment works and its safety profile. Participants will receive UGN-104 once a week for six weeks, with each dose administered directly into the upper urinary tract via a ureteral catheter or nephrostomy tube. The dose consists of 4 mg mitomycin per 1 mL sterile hydrogel. After the initial treatment period, patients who have no detectable disease at the primary disease evaluation visit about three months after the first dose may enter a follow-up phase where they could receive monthly maintenance doses for up to 11 months, depending on the investigators decision. During the study, participants will have evaluations every three months to check for disease response or recurrence. These assessments include urine cytology, visual inspection via ureteroscopy, and biopsies if needed. Researchers will monitor the complete response rate at three months as the primary outcome and track the duration of response, durable complete response rate, and any treatment-related side effects for up to 15 months. The total participation time varies depending on response and disease status.

Researchers are evaluating the use of pemigatinib for adults with advanced or metastatic pancreatic cancer that has spread locally or to distant parts of the body. This study focuses on patients whose cancer has specific abnormal changes in the FGFR gene, which can promote cancer growth. The goal is to see if pemigatinib can block these abnormal genes to stop tumor growth and improve quality of life. Participants take pemigatinib orally once daily for 14 days in each 21-day cycle, continuing as long as the cancer does not worsen or side effects are manageable. During the study, patients undergo blood tests, CT andor MRI scans, and optical coherence tomography OCT. Additional scans like whole body bone scans and eye exams may be performed if needed. After treatment, patients are followed up 30 days later and then every 4 months for one year. Throughout the study, researchers assess tumor response using imaging and blood tests, including monitoring cell-free DNA to track response and resistance. They measure overall response rate up to 24 months and evaluate progression-free survival, disease control, overall survival, and side effects up to 12 months. Safety and tolerability are closely monitored, and patients overall health and treatment effects are regularly checked to understand the impact of pemigatinib.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

This research aims to evaluate how CDR132L, a potential new medicine, affects the structure and function of the heart in people living with heart failure who have preserved ejection fraction and left ventricular hypertrophy. The study compares different doses of CDR132L to a placebo, with treatment assignment determined randomly. It is a phase 2, multicenter, randomized, double-blind, placebo-controlled trial sponsored by Novo Nordisk AS, lasting about 60 weeks. Participants will receive intravenous infusions of one of three doses of CDR132L or placebo once every 4 weeks for 48 weeks. Alongside the study drug or placebo, participants will continue their individually adapted guideline-directed standard of care therapy for heart failure. This treatment period is followed by an extension phase to monitor safety and efficacy. During the study, participants will undergo assessments including measuring the change in normalized microRNA-132-3p levels from baseline to week 24, as well as cardiac magnetic resonance imaging to evaluate heart structure changes and blood tests like NT-proBNP levels. Safety is monitored by recording adverse events up to week 60. The total participation duration is approximately 60 weeks, involving regular infusions and follow-up visits.

Researchers are evaluating the safety and effectiveness of a new medicine called CagriSema in helping adults living with obesity, with or without type 2 diabetes, to lose weight. This phase 3 clinical study compares two different weekly doses of CagriSema against an existing medicine, semaglutide. The study aims to understand how well these treatments support weight loss over a long period. Participants in this study will be randomly assigned to receive one of three treatments CagriSema at dose level 1, CagriSema at dose level 2, or semaglutide. Each treatment is given by weekly injection under the skin for 72 weeks. The study lasts about 83 weeks, covering treatment and follow-up periods to observe effects and safety. During the study, participants will have regular assessments to monitor body weight, body mass index BMI, waist size, cholesterol levels, blood sugar control HbA1c, and quality of life. Researchers will track changes from the start of treatment to the end of 72 weeks, including weight loss milestones and health measurements. Safety will also be closely monitored through reports of any adverse events until the study ends.