A Phase 3, Randomized, Open-label, Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat (MK‑3543/IMG-7289) versus Best Available Therapy (BAT) in Participants With Essential Thrombocythemia who have an Inadequate Response to or are Intolerant of Hydroxyurea.

Date Added
February 18th, 2025
PRO Number
Pro00141947
Researcher
Alexander Coltoff

List of Studies

Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This phase 3 study is recruiting patients who have Essential Thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. This study will measure the safety and effectiveness of an inhibitor treatment called bomedemstat. Bomedemstat is an "investigational" (not yet FDA approved) treatment. The main purpose of the study is to how bomedemstat compares to BAT (best available therapy) as an effective treatment for ET. The study will enroll approximately 300 patients who will be randomly assigned 1:1 (like flipping a coin) to either bomedemstat or BAT. The study includes a screening phase, initial treatment phase, extended treatment phase, and posttreatment phase. The initial treatment portion of the study begins on study Day 1 and continues until the participant completes treatment at Week 52. The primary endpoint analysis will be performed on data from the first 52 weeks of treatment. Patients who have not discontinued study treatment at Week 52 will be eligible to continue receiving study treatment in the Extended Treatment Phase for up to Week 156. Patients in the BAT arm who have received a minimum of 52 weeks of treatment and discontinued study treatment due to intolerance/resistance/refractoriness/inadequate response (defined by the investigator as per the local product labels of BAT regimens) may be eligible to switch to the bomedemstat arm during the Extended Treatment Phase at the investigator's discretion (as per protocol defined eligibility to receive bomedemstat). Patients will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance with Cell-free DNA versus Endomyocardial Biopsy (ACES-EMB)

Date Added
February 25th, 2025
PRO Number
Pro00141118
Researcher
Adrian Van Bakel

List of Studies


Keywords
Cardiovascular, Heart, Transplant
Summary

This study is an open label, Comparative Effectiveness Research study in patients who receive a heart transplant. Subjects will be enrolled into the study while under evaluation for heart transplantation or on the transplant waiting list prior to heart transplantation. All subjects will follow the center's standard of care surveillance schedule from transplant through 4 weeks post-transplantation. The study objective is to compare the effectiveness of rejection surveillance of heart transplant recipients with Prospera dd-cfDNA to rejection surveillance with endomyocardial biopsy (EMB) in the first post-transplant year.
The Prospera™ test is a non-invasive test intended to detect and quantify the fraction of donor-derived cell-free DNA (dd-cfDNA) to supplement management and surveillance of allograft rejection in patients who have undergone organ transplantation. The subjects may undergo blood draws, echocardiogrphys, medical history and physical exams, antibody testing, nuclear imaging, and MRI as apart of the study. The study period will be during the first 12 months post-transplant. Quality of life questionnaires will be completed at week 4, month 6 and month 12 post-transplant.

Institution
MUSC
Recruitment Contact
Madison Johnson
8437924615
johme@musc.edu

PICANTE: PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm

Date Added
February 25th, 2025
PRO Number
Pro00141297
Researcher
Anbukarasi Maran

List of Studies


Keywords
Heart, Surgery
Summary

This study is enrolling subjects with coronary artery disease (blockages in the arteries that supply blood to the heart) who need to undergo a procedure called a Percutaneous Coronary Intervention (PCI) to open up a blocked heart artery. At times, a heart pump is used during a PCI to help reduce the work the heart during the procedure. This study is evaluating a heart pump called the KARDION CORY P4 pump. The KARDION CORY P4 pump is investigational meaning it has not been approved for commercial use by the Food and Drug Administration (FDA). This study will randomize subjects, meaning assign by chance, to receive either the KARDION CORY P4 pump or the Impella CP, which is commercially available.

Study participation will last about 30 days and include up to 6 visits. The study includes blood work, questionnaires, an electrocardiogram (ECG) - a tracing of the heart's electrical activity and an echocardiogram (Echo) - an ultrasound test of the heart.

Risks include risks related to the study device including bleeding, infection, and injury to the blood vessel where the device is placed. There are also risks related to study procedures. There may be benefit and the information learned may benefit others in the future.

Institution
MUSC
Recruitment Contact
Virginia Theodorof
843-876-9078
theodoro@musc.edu

A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

Date Added
March 5th, 2025
PRO Number
Pro00138827
Researcher
Alexander Coltoff

List of Studies

Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This phase 3 study is recruiting patients who have myelofibrosis who have never had a JAK inhibitor. This study will measure the safety and effectiveness of a tumor protein inhibitor treatment called navtemadlin combined with another tumor protein inhibitor called ruxolitinib. Navtemadlin is an "investigational" (not yet FDA approved) treatment, Ruxolitinib is FDA approved. The main purpose of the study is to see if navtemadlin combined with ruxolitinib is an effective treatment for myelofibrosis. The study will enroll approximately 180 patients with each patient initially receiving ruxolitinib. The study includes a screening period, run-in period, and a randomized (like flipping a coin) add-on period. The first two periods will be over the course of 18-24 weeks while the randomized add-on period is for those whose treatment with ruxolitinib is not effective enough and will last for a different amount of time for each patient. In the run-in period after screening, patients will take ruxolitinib at the dose determined by their study doctor for 18-24 weeks. If treatment with ruxolitinib alone is not effective, the participate will be randomized into one of two groups. In the randomized add-on period, participants will either receive ruxolitinib with navtemadlin 240 mg or a matching placebo (a pill that contains no medicine) daily for one week out of the 28-day cycle in combination with ruxolitinib at a dose determined by their study doctor. Patients in this group will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

Randomized Phase III Study of Mosunetuzumab vs. Rituximab for low Tumor Burden Follicular Lymphoma

Date Added
March 6th, 2025
PRO Number
Pro00142136
Researcher
Brian Hess

List of Studies


Keywords
Cancer, Cancer/Lymphoma, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects diagnosed with follicular lymphoma. The purpose of this study is to assess if treatment with Mosunetuzumab can improve long term remission in patients with low tumor burden follicular lymphoma compared to rituximab. The treatment period for the Rituximab arm is approximately 40 weeks. The treatment period for the Mosunetuzumab arm is approximately 24 weeks. However the subject may remain in the study for up to 10 years for the follow-up period.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Drowning Risks of Patients Presenting to the Pediatric Emergency Department at MUSC's Shawn Jenkins Children's Hospital

Date Added
March 11th, 2025
PRO Number
Pro00142153
Researcher
M. Titus

List of Studies


Keywords
Pediatrics
Summary

This study is seeking to assess two known risk factors of drowning, swimming ability and water safety knowledge, in parents of children and adolescents presenting to the pediatric emergency department using questionnaires.

By collecting this data, we hope to highlight factors that contribute to disparities in drowning rates in minority racial and ethnic groups and to aid local and federal governments in developing programs that effectively combat the number one cause of unintentional injury-associated death in children ages 1-4 years. This will also provide data that may help guide pediatricians in effective anticipatory guidance for families regarding water safety. All in the effort to minimize disparities in medicine and provide more equitable care to the patients that we see.

Institution
MUSC
Recruitment Contact
M. Titus
8434753656
titusda@musc.edu

Dynamic motor cortical responses to subdural electrical stimulation.

Date Added
March 18th, 2025
PRO Number
Pro00142103
Researcher
Nathan Rowland

List of Studies


Keywords
Parkinsons
Summary

Current surgical treatments for Parkinson's disease have associated risks that may prevent patients from being offered surgery called "deep brain stimulation" or DBS. This is mainly because electrodes have to be placed through brain tissue to reach the target. Stimulation at the surface of the brain might be a potential alternative, but current research has not shown consistent results, and this may be because the mechanism of action is not clear. In this study, we aim to stimulate and record the brain at the surface to help answer this question and potentially improve the consistency and effectiveness of this treatment.

Institution
MUSC
Recruitment Contact
M S Zobaer
8329557191
zobaer@musc.edu

A Neural Basis for Cognitive Decline Following Deep Brain Stimulation: A DBS-fMRI Study

Date Added
March 18th, 2025
PRO Number
Pro00142451
Researcher
Daniel Lench

List of Studies

Keywords
Brain, Parkinsons
Summary

The purpose of this research study is to learn how Deep Brain Stimulation (DBS), which targets a part of the brain called the subthalamic nucleus (STN), may affect thinking and memory in people with Parkinson's Disease (PD). We plan to include about 55 people with PD who have already had DBS surgery at MUSC's Clinical DBS Program.

As part of the study, participants will attend two visits after their DBS surgery. The first visit, which will last about three hours, includes going over the study information and consent form, collecting background information (demographics), and completing tests that measure thinking and memory (cognitive assessments) and speech. The second visit, also about three hours, will involve an MRI scan to look at how the brain's networks change when the DBS device is turned on and off. Participant's will also be invited to undergo an optional second scan. If participants consent, the second scan will be performed on a separate day than the first scan and therefore, there will be a total of 3 study visits.

These findings may help doctors and researchers make better decisions about which patients are most likely to benefit from DBS surgery and how to choose the best stimulation settings to reduce unwanted changes in thinking and memory.

Institution
MUSC
Recruitment Contact
Niloufar Malakouti
843-792-0235
malakout@musc.edu

A Randomized, Controlled, Multiregional Phase 3 Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Squamous Nonsmall Cell Lung Cancer

Date Added
March 21st, 2025
PRO Number
Pro00138993
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies
Summary

The main purpose of this study is to measure overall survival (OS) and safety of ivonescimab (study drug) when combined with chemotherapy drugs carboplatin, paclitaxel or nab-paclitaxel compared to pembrolizumab combined with chemotherapy drugs carboplatin, paclitaxel or nab-paclitaxel. Participants will undergo screening procedures done to determine if they meet the requirements to be in this study. Screening will be completed within 28 days before receiving the study drug. Many of these screening measures are likely part of regular cancer care and may be done even if it turns out that you do not participate in the research study.

Once enrolled in the study, participants will visit the clinic every three weeks for 4 cycles of ivonescimab plus chemotherapy or pembrolizumab and chemotherapy for up to four infusions, followed by ivonescimab or pembrolizumab every three weeks for up to 24 months. If a participant's physician decides to use nab-paclitaxel chemotherapy for the first 4 cycles of treatment, the schedule of treatment is different and will require that the participant comes to the clinic for this infusion on days 1, 8, and 15 of each cycle. There will be follow-up check-up visits with the study team approximately 7 days, 30 days and 90 days after the last treatment or before the participant starts a new treatment for the cancer. Ninety (90) days after the participant stops taking the study drug, there will be a call or a visit scheduled to review how the they are feeling. This is a survival call/visit and will happen every 90 days until the end of the study. Participation in this study will last about 4 years, 2 years in active treatment and 2 years in follow up.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@musc.edu

Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients with Heart Failure and Reduced Ejection Fraction

Date Added
March 25th, 2025
PRO Number
Pro00142732
Researcher
Brian Houston

List of Studies


Keywords
Cardiovascular, Heart
Summary

This study is enrolling subjects with heart failure and a reduced ejection fraction meaning the heart does not pump enough blood to meet the body's needs. This study is researching an investigational device (study device) called the Alleviant ALV1 System. Investigational means it has not been approved for commercial use by the Food and Drug Administration. (FDA) This study will test the safety and effectiveness of the Alleviant ALV1 System. The Alleviant ALV1 System is intended to create a shunt (an opening) in the heart to allow for proper blood flow through the heart which may improve your symptoms. No device is left in your heart it is just used to create the shunt. This is a randomized study which means subjects are assigned by chance to either have the study device create this shunt or not have the study device create the shunt. Randomization is 50/50 meaning there is a 50% chance to have the study device create a shunt and a 50% chance the study device will not be used. Using the study device to create the shunt is performed during a right heart catheterization (RHC) so all subjects will undergo the RHC but only 50% will have the shunt. Neither the subjects nor the study doctor will know which group subjects are randomized to but other study staff will know in the event this information is needed. All subjects will stay overnight in the hospital after the procedure. Other study related procedures include echocardiograms - ultrasound test of the heart, electrocardiograms (ECG) - a tracing of the heart's electrical activity, blood work, questionnaires, 6 minute hall walk test, and assessments of heart failure status. Risks include risks related to the study device including blood vessel damage from placing the device in the vein to get to the heart, risks from the right heart catheterization such as bleeding or bruising, abnormal heart beats, and risks related to study related procedures. There may be risks that are not known at this time. Participation in this study is expected to last about 60 months and include approximately 15 in person visits and 3 telephone calls.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
843-876-5783
shr37@musc.edu



-- OR --