St. George

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. This phase 2 study compares the effects of zilovertamab vedotin combined with R-CHP chemotherapy versus polatuzumab vedotin combined with R-CHP in people newly diagnosed with this type of lymphoma. The goal is to see if the cancer responds better to one treatment over the other. Participants will be randomly assigned to receive either zilovertamab vedotin or polatuzumab vedotin, both given by intravenous infusion on the first day of each 3-week cycle for up to six cycles (about 4 months). Alongside these drugs, participants will receive cyclophosphamide, doxorubicin, and rituximab or a rituximab biosimilar by IV infusion, plus prednisone or prednisolone orally for five days each cycle. Those with high-risk DLBCL may receive two additional cycles of rituximab or its biosimilar. During the study, participants will have scans and tests to measure cancer response using established criteria over up to 31 months. Researchers will also monitor survival rates, quality of life, and side effects for up to several years. Safety assessments and treatment adherence will be tracked throughout the study and follow-up periods, ensuring thorough evaluation of each treatment's impact.

Researchers are evaluating the safety of atezolizumab alone or combined with bevacizumab as first-line treatments for participants with unresectable, locally advanced, or metastatic hepatocellular carcinoma (HCC) who have Child-Pugh B7 or B8 liver cirrhosis. This Phase II, open-label study focuses on patients who have not received previous systemic therapy in this setting and aims to assess treatment safety in this specific population. Participants are assigned to one of two groups: Cohort A receives atezolizumab plus bevacizumab, and Cohort B receives atezolizumab alone. Both drugs are given by intravenous infusion every 21 days, with atezolizumab dosed at 1200 mg and bevacizumab at 15 mg/kg. Treatment continues until unacceptable side effects or loss of clinical benefit occur, as determined by the investigator. During the study, participants undergo regular assessments to monitor safety and treatment effects, including tracking adverse events from the start of treatment up to about 36 months. Evaluations include clinical exams, laboratory tests, and imaging to measure disease status. The study also monitors liver function and overall health, with follow-up visits to ensure participant safety throughout the trial period.

Researchers are evaluating the effectiveness and safety of LY3938577 compared to degludec in people with type 2 diabetes who have been previously treated with basal insulin. This Phase 2 trial aims to understand how well LY3938577 works in managing blood sugar levels in this patient population. The study is sponsored by Eli Lilly and Company and participation lasts about 26 weeks. Participants are randomly assigned to receive either LY3938577 or degludec, both given by subcutaneous injection. The study compares these two treatments to observe differences in glucose control and safety. The trial design is open-label, meaning both participants and researchers know which treatment is given. Throughout the study, researchers will monitor changes in blood sugar levels, specifically the time glucose remains in the target range of 70 to 180 mg/dL from baseline to week 20. Other measures include changes in hemoglobin A1c and drug concentration levels. Safety and treatment effects are assessed at regular intervals during the 26-week participation period.

This study aims to collect prospective safety and effectiveness data for the C-Brace System, a microprocessor-controlled knee ankle foot orthosis, following standard care practices. The research focuses on patients with lower extremity pareses who are fitted with the C-Brace device. The goal is to better understand how the C-Brace influences walking speed, balance, risk of falling, and confidence in balance over time. The C-Brace is a custom-made device with thigh, calf, and foot components connected by an ankle joint or spring element. It uses sensors to continuously monitor knee joint movement and walking phases, adjusting hydraulic resistance and knee motion accordingly. Patients enrolled in the registry will undergo baseline evaluation, fitting, training or therapy sessions, and follow-up visits at 6, 12, 24, and 36 months after fitting. Participants will be assessed through various tests including timed walk tests, balance confidence scores, and mobility assessments at different intervals. The study also tracks falls related to device use and changes in activity levels with an activity tracker. Data collected will help characterize the safety and functional impact of the C-Brace over three years of follow-up.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer based on the presence or absence of circulating tumor DNA (ctDNA) after surgery. This Phase II/III trial focuses on patients with Stage IIB, IIC, or Stage III colon adenocarcinoma who have undergone tumor removal. The study aims to use ctDNA status to better predict the risk of cancer recurrence and guide decisions about adjuvant chemotherapy. Participants will be assigned to different treatment groups based on their ctDNA status after surgery. Patients without detectable ctDNA will undergo serial ctDNA monitoring without immediate treatment or receive standard chemotherapy regimens such as mFOLFOX6 or CAPOX for varying durations. Patients with detectable ctDNA will receive either standard chemotherapy or intensified regimens like mFOLFIRINOX. Treatments involve intravenous and oral chemotherapy drugs given over several cycles spanning weeks to months. Throughout the study, participants will have ctDNA testing using the Signatera test and be monitored for disease-free survival, overall survival, and recurrence up to five years after randomization. Safety and treatment adherence will also be tracked. Regular imaging and laboratory tests will assess disease status and organ function. The study may include re-randomization for patients who develop positive ctDNA during monitoring. Total involvement may last several years with follow-up for long-term outcomes.

Researchers are evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

Researchers are evaluating the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System for patients with symptomatic severe tricuspid regurgitation who are at intermediate or higher risk of death from tricuspid valve surgery. This pivotal, prospective, multicenter, randomized, controlled trial compares the Edwards PASCAL system plus optimal medical therapy (OMT) to OMT alone in treating tricuspid regurgitation. The study is led by Edwards Lifesciences and aims to improve patient outcomes using this device. Participants are assigned to one of several groups: receiving transcatheter tricuspid valve repair with the Edwards PASCAL system plus OMT, OMT alone, or transcatheter repair with the Edwards PASCAL system outside the randomized groups. The Edwards PASCAL device is delivered through a minimally invasive transcatheter procedure to repair the tricuspid valve. Follow-up visits occur at hospital discharge, 30 days, 3 months, 6 months, and then annually for up to 5 years to monitor patient progress and outcomes. Throughout the study, participants undergo evaluations measuring mortality, heart failure hospitalizations, need for additional heart procedures, and quality of life using the Kansas City Cardiomyopathy Questionnaire. Researchers will also assess heart function via ultrasound measurements and monitor adverse events. Participants will be closely followed over several years to track the long-term effects and safety of the Edwards PASCAL system combined with medical therapy compared to medical therapy alone.

Researchers are evaluating the effects and side effects of adding inotuzumab ozogamicin, a monoclonal antibody, to frontline chemotherapy in young adults with newly diagnosed B acute lymphoblastic leukemia. This phase III trial aims to confirm the tolerability and assess whether this combination improves event-free survival compared to standard pediatric-inspired chemotherapy regimens. The study also explores impacts on disease-free survival, overall survival, minimal residual disease, genetic markers, and treatment adherence. Participants receive a multi-phase treatment plan starting with remission induction therapy including several chemotherapy drugs and intrathecal medications. Patients responding to induction are randomized to either continue with standard chemotherapy alone or with the addition of inotuzumab ozogamicin. Treatment courses include remission consolidation, interim maintenance, delayed intensification, and maintenance therapy, with specific drug schedules and doses detailed across the phases. Bone marrow biopsies are performed at key points to monitor disease status. During the study, patients undergo regular clinical assessments including bone marrow aspiration and biopsy, laboratory biomarker analyses, and adherence monitoring for oral chemotherapy drugs. Researchers track outcomes such as event-free survival over three years and longer-term disease-free and overall survival up to ten years. Safety and side effects are monitored throughout, with follow-up visits occurring monthly in the first year and gradually spacing out to every six months up to ten years after treatment completion.

Researchers are investigating treatments for patients with high-risk smoldering multiple myeloma, a condition where abnormal plasma cells grow in the bone marrow but without symptoms. This phase III trial evaluates how well lenalidomide and dexamethasone work together, with or without the addition of daratumumab, an immunotherapy drug. The study aims to compare overall survival, progression-free survival, response rates, and quality of life between these two treatment approaches. Participants are randomly assigned to one of two treatment groups. One group receives daratumumab intravenously on a set schedule alongside oral lenalidomide daily and dexamethasone on specific days within repeated 28-day cycles, up to 24 cycles. The other group receives lenalidomide and dexamethasone on a similar schedule without daratumumab. Treatment continues until disease progression or unacceptable side effects occur. After treatment, patients are followed up for up to 15 years to monitor long-term outcomes. Throughout the study, participants undergo evaluations including blood and urine tests, bone marrow biopsies, and imaging scans such as FDG-PET/CT. Researchers assess treatment response, minimal residual disease status, safety, and quality of life using questionnaires. They also monitor treatment adherence and side effects, including infusion reactions. The main outcomes measured are overall survival and changes in quality of life. Safety and various laboratory and imaging markers are regularly reviewed to understand treatment effects and disease progression.

Researchers are evaluating the long-term safety and efficacy of plozasiran in adults with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (SHTG). This open-label Phase 3 extension study includes participants who completed prior related studies and meet specific medical and eligibility criteria, including controlled HbA1c levels. The trial aims to monitor treatment-emergent adverse events and changes in various lipid and cardiovascular markers over 24 months. Participants will receive eight doses of plozasiran, given by subcutaneous injection approximately every three months for two years. Throughout the study, participants are advised to maintain a low-fat diet consistent with local standard care. Additional criteria apply for certain participants transitioning from earlier studies, ensuring proper health status and treatment history. During the study, participants will undergo regular assessments including blood tests to measure triglycerides, cholesterol types, apolipoproteins, and HbA1c. Researchers will also track cardiovascular events, anti-drug antibodies, and any emergent need for apheresis. The trial spans 24 months with continuous monitoring of safety and lipid-related outcomes to understand the long-term effects of plozasiran treatment.