Buffalo

Researchers are evaluating the safety and effectiveness of elenestinib (BLU-263) combined with symptom-directed therapy (SDT) compared to placebo plus SDT in people with indolent systemic mastocytosis (ISM) whose symptoms are not well controlled by SDT alone. This Phase 2/3 randomized, double-blind, placebo-controlled study includes participants with ISM and smoldering systemic mastocytosis, and also involves groups for pharmacokinetic studies and participants who previously received a selective KIT inhibitor. The study is divided into multiple parts. Parts 1 and 2 enroll participants with ISM who will receive either elenestinib oral tablets or placebo alongside their symptom-directed therapy. Participants from Part 2 may continue into Part 3, which is an open-label extension where all receive elenestinib. Part K enrolls participants with ISM who have prior experience with selective KIT inhibitors. The study tracks treatment effects and safety over time. Participants will be monitored for up to 5 years, with assessments including the number of treatment-emergent adverse events, changes in symptom scores measured by the ISM-Symptom in Assessment Form, and overall safety monitoring. Evaluations occur at baseline, 13 weeks, 49 weeks, and throughout the long-term follow-up. The study also includes detailed tracking of symptom control and adverse events to evaluate the impact of treatment on participants' health and quality of life.

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Researchers are evaluating the effectiveness and safety of Xeomin injections in preventing chronic migraine. This Phase 3 clinical trial compares Xeomin to placebo injections given into muscles of the head and neck. Participants have chronic migraine diagnosed for at least 12 months and meet specific headache and migraine day criteria. The study aims to measure changes in monthly migraine days over time with Xeomin treatment. Participants will receive four treatments spaced about 12 weeks apart over a total study duration of 52 to 55 weeks. The treatments involve injections of either Xeomin or placebo solution prepared with sodium chloride. Visits occur approximately every 4 weeks, totaling 14 visits: the first, last, and four treatment visits are on-site, while the other eight visits are remote via phone or video call. During the study, participants will keep headache diaries to track migraine and headache days. Researchers will focus on the change in monthly migraine days from baseline to six months after the first injection. Safety and effectiveness are monitored throughout, with frequent assessments during both on-site and remote visits to ensure accurate tracking of migraine symptoms and any side effects.

Researchers are evaluating the effect of Xeomin injections compared to placebo injections for preventing episodic migraine. This phase 3 clinical trial focuses on adults who experience episodic migraine, aiming to measure changes in the number of migraine days per month. Participants must have a diagnosis of episodic migraine for at least 12 months and meet specific headache frequency criteria. Participants will receive four treatments of either Xeomin or placebo injections into muscles of the head and neck, with treatments spaced about 12 weeks apart. The entire trial lasts approximately 52 to 55 weeks, beginning with a screening period of 4 to 5 weeks. There are about 14 visits in total, with the first, last, and four treatment visits conducted on-site, while the other visits are held remotely via phone or video. Throughout the study, participants will track their migraine days using a headache diary, and researchers will assess changes in monthly migraine frequency from baseline to six months after the first injection. Regular monitoring includes both in-person and remote assessments. The primary outcome focuses on the change in monthly migraine days between baseline and month six after treatment initiation.

Researchers are evaluating a community health education program called I CAN designed to encourage community-driven actions to reduce the cancer burden in Western New York. The study focuses on engaging community members to help design effective programs and policies to address cancer impacts. The I CAN intervention includes educational components about social networks and cancer burden, aiming to empower participants to take meaningful actions at the community level. Participants will attend a 2-hour I CAN workshop that includes a presentation on key concepts, a structured skill-building activity, and motivating exercises to foster enthusiasm and momentum for action. The intervention is evaluated for its feasibility, acceptability, and the specific topics participants choose to address in their plans for action. Ancillary surveys are also conducted as part of the study. During the study, participants are involved in the workshop and complete surveys related to the intervention. Researchers will measure the demand, practicality, and acceptability of the I CAN program over a period of up to 2 years. The study aims to understand how well the intervention can engage the community and support ongoing grassroots efforts to reduce cancer risks.

Researchers are evaluating a healthy eating program designed to reduce the return or worsening of non-muscle invasive bladder cancer (NMIBC) in adults. This phase II trial focuses on how increasing the intake of cruciferous vegetables, such as cabbage, kale, and broccoli, may lower the risk of cancer recurrence or progression in patients diagnosed with early-stage bladder cancer. The study compares the effects of extending this dietary program to see if it further improves bladder cancer outcomes. The study involves two groups: one participating in the POW-R Health Only/Core program, which is a behavioral dietary intervention aimed at modestly increasing cruciferous vegetable intake, and the other receiving POW-R Health plus an added maintenance component. Participants will receive support through live phone calls as part of the telephone-based intervention. The trial includes a 2-group randomized controlled design with 344 participants to assess the efficacy of the interventions. During the study, researchers will monitor levels of urinary isothiocyanates (ITCs), which are compounds from cruciferous vegetables that may have anticancer properties. These levels will be measured from baseline throughout the study, lasting up to 24 months. The study also assesses changes in cruciferous vegetable intake. Participants will be evaluated through questionnaires and other assessments to track adherence and outcomes related to bladder cancer recurrence or progression.

Researchers are investigating BGB-16673, a targeted protein degrader aimed at treating various B-cell cancers including marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, Waldenström macroglobulinemia, and diffuse large B-cell lymphoma. The study includes both Phase 1 and Phase 2 parts to determine safe and effective dosing and to evaluate the drug's response in patients. The trial is conducted under the new company name BeOne Medicines, previously known as BeiGene. The treatment involves oral administration of BGB-16673. Phase 1 focuses on dose escalation and safety expansion to identify the maximum tolerated dose and recommended dose for expansion over approximately 28 days to 3 years. Phase 2 includes expansion cohorts to assess overall response rates over about 3 years. Participants may have prior treatments including Bruton tyrosine kinase inhibitors and other anticancer therapies depending on their cancer type and study phase. Participants will be monitored closely with assessments of adverse events from the first dose until 30 days after the last dose or before starting new therapy, whichever comes first, for up to 47 weeks. The study measures tolerability, dosing recommendations, and treatment response. Eligibility assessments include performance status and measurable disease, with safety and response evaluations continuing through both phases for up to three years.

Researchers are investigating whether buntanetap/Posiphen can help treat early Alzheimer's disease in adults aged 55 to 85 years. This Phase 3 study aims to find out if buntanetap/Posiphen improves thinking abilities and daily functioning compared to a placebo. It also evaluates the safety of buntanetap/Posiphen by monitoring any medical issues that participants may experience during the trial. Participants will take either a 30 mg capsule of buntanetap/Posiphen or a placebo capsule by mouth once daily for 18 months. The study includes regular clinic visits at screening, enrollment, and months 1, 3, 6, 9, 12, 15, and 18. During some visits, participants will have brain MRI scans. The study uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo. Throughout the study, participants will complete tests and questionnaires to measure cognitive function and daily living activities, including the ADAS-Cog13 and ADCS-iADL scales. Phone calls before and after visits help track progress and adherence. Safety is closely monitored with ongoing assessments from screening through the 18-month treatment period.

Researchers are evaluating a financial intervention called Financial Compass compared to usual care to identify and address financial hardship in patients with head and neck cancer. This study aims to tailor the Financial Compass intervention to the needs of these patients and conduct a pilot randomized trial to assess its feasibility, acceptability, and preliminary effectiveness. Prior research has shown that financial difficulties in these patients are linked to lower overall and cancer-specific survival. The study has two main parts: first, participants join advisory boards to help develop and refine the Financial Compass intervention. Then, in the pilot trial, patients are screened for financial concerns and randomized into two groups. One group receives the Financial Compass intervention, which includes a patient needs assessment, a customized care plan, and weekly personalized support to access resources. The other group receives usual medical care and supportive care. After the intervention period, patients are followed up at 12 weeks. During the study, patients complete questionnaires to identify financial hardship and receive ongoing support or standard care depending on their group. Researchers monitor feasibility and acceptability of the intervention over up to 12 weeks, with development work lasting up to 2 years. The study involves assessments in English or Spanish and focuses on improving identification and assistance for financial challenges faced by head and neck cancer patients.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.