Randomized Phase II study of the Addition of Targeted Therapeutic Agents to Tafasitamab-based Therapy in Non-Transplant-Eligible Patients With Relapsed/Refractory Large B-cell Lymphoma

Date Added
July 10th, 2025
PRO Number
Pro00146204
Researcher
Brian Hess

List of Studies


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

This is a randomized, phase II study for patients with Relapsed/Refractory Large B-Cell Lymphoma. The purpose of this study is to determine how long people with Large B-Cell Lymphoma can live without their disease getting worse when treated with two different combinations of cancer drugs. One group will get tafasitamab + lenalidomide + tazemetostat, and the other group will get tafasitamab + lenalidomide + zanubrutinib. The researchers want to see which combination works better. They also want to figure out the best and safest dose of each drug combination to use in future studies. Tafasitamab is a lab-made antibody that helps the immune system find and attack cancer cells. Lenalidomide is a drug that boosts the immune system and helps fight cancer. Tazemetostat is a drug that blocks a protein (EZH2) that helps cancer cells grow. Zanubrutinib is a drug that blocks another protein (BTK) involved in cancer cell survival. The treatment period may last approximately 1 year and the follow up period may last up to 3 years.

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

Randomized Phase II Trial of Anti-LAG-3 and Anti-PD-1 Blockade vs. SOC in Patients With Recurrent Glioblastoma

Date Added
July 10th, 2025
PRO Number
Pro00143650
Researcher
Scott Lindhorst

List of Studies


Keywords
Cancer, Cancer/Brain, Men's Health, Women's Health
Summary

This is a phase 2 study for patients that have been diagnosed with recurrent glioblastoma, a type of brain cancer. This study is testing an investigational combination of two drugs, reltalimab and nivolumab."Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The main purpose of this study is to see if there is a difference in overall survival rate in patients who receive a combination of retatlimab and nivolumab versus those who receive the standard of care treatment, lomustine, in patients with recurrent brain cancer. Participants in this study can expect to be in this study for up to five years from the day study participation starts. Subjects with investigational project being given on day 1 of each cycle, a cycle being 28 days. Cycles will continue until disease gets worse or study doctor decides it is in the subject's best interest to stop. Study will be divided into group 1 and 2. Group 1 will receive investigational drugs and group 2 will receive the standard of care. A computer will be used to assign groups in a process called randomization. Much like a toss of a coin, subjects will have equal opportunity to randomized to either group 1 or 2.

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

Exploring the Interplay of Resiliency and Grit in Athlete Burnout and Injury Rates Among Adolescent Volleyball Players

Date Added
July 18th, 2025
PRO Number
Pro00140770
Researcher
Kelsey Turner

List of Studies

Keywords
Adolescents, Children's Health, Exercise, Pediatrics
Summary

This study aims to look at injury rates experienced during a club travel volleyball season as correlated with self reported scores on the GRIT scale, Brief Resiliency Scale (BRS), and Athlete Burnout Questionnaire (ABQ) in male and female high school age volleyball players. The GRIT asks questions about passion and perseverance to achieve goals.
The BRS asks questions about resiliency after stress.
The ABQ asks questions to understand the determinants and consequences of athlete burnout. Completion of these surveys will take approximately 20 minutes.

Upon receiving and compiling all survey data, appropriate statistical analysis will be performed to assess for trends in the development of injuries and inform best practice on training.

Institution
MUSC
Recruitment Contact
Stephanie McGowan
8437927356
mcgowan@musc.edu

A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation

Date Added
August 11th, 2025
PRO Number
Pro00146236
Researcher
Jonathan Alexander

List of Studies

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

This phase 3 study is recruiting patients who are at risk of graft-versus-host disease (GVHD) after a bone marrow transplant. This study will measure the safety and effectiveness of a prevention treatment combination called Tacrolimus/Methotrexate/Ruxolitinib compared to Standard of Care (SOC), Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil. Ruxolitinib (Rux) is an approved treatment for GVHD. This study is divided into two parts. The first part, called the run-in phase, will investigate the best dose of Ruxolitinib. The second part of the study will compare the SOC combination therapy with the investigational combination therapy (which will include Ruxolitinib). Participants will be randomly assigned to one of the two groups (like flipping a coin). The study will enroll up to 572 patients nationwide and 5 at MUSC. The participants can expect to be involved in the study for at least 24 months. The main risk is that medical treatments often cause side effects. The most common side effects expected from the investigational combination therapy are high cholesterol, increased liver enzymes, low platelet levels, and low red blood cell counts. 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

Pilot Trial of Written Exposure Therapy Delivered via Telehealth to Adolescents with Posttraumatic Stress Disorder

Date Added
November 4th, 2025
PRO Number
Pro00147573
Researcher
Emily Tilstra-Ferrell

List of Studies

Keywords
Adolescents, Mental Health
Summary

Written Exposure Therapy (WET) is a five-session mental health therapy for post-traumatic stress disorder (PTSD). Research shows that it works as well as longer treatments for PTSD among people over 18, even though it requires fewer sessions than other PTSD therapies. However, WET has not been adapted and tested via telehealth with people aged 12 to 18. Our study aims to see how WET can be adapted to meet the needs of people aged 12 to 18 who have experienced trauma and currently have PTSD symptoms. To adapt WET for this age group, first we will talk with PTSD experts and people aged 12 to 18 to learn what changes might make WET more suitable for young people. We'll also deliver WET via telehealth to five people aged 12 to 18 following the manual as it is written for people over age 18 to see what needs adjusting. In the next part of the study, we will offer the adapted version of WET via telehealth to 20 people aged 12 to 18 in our MUSC integrated pediatric primary care clinic. People aged 12 to 18 will take part in five to seven weekly online therapy sessions and three virtual study visits (before therapy, after therapy, and one month later) to better understand who they are as a person and their current mental health symptoms and diagnoses. Individuals who are 18 can participate without caregiver permission; individuals aged 12 to 17 can only participate with caregiver permission. Our goal is to find the best way to provide effective PTSD treatment for young people that can be delivered in real-world pediatric primary care settings, so that ultimately more people can get the help they need after traumatic experiences.

Institution
MUSC
Recruitment Contact
Owen Winters
843-792-2615
winterso@musc.edu

An Interventional Study to Evaluate Treating to a Target of Transmural Healing in Patients with Moderately to Severely Active Crohn's Disease (VECTORS)

Date Added
December 11th, 2025
PRO Number
Pro00147428
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease
Summary

The purpose of this research study is to determine the best treatment goals for patients with active CD. Researchers are investigating how treating and monitoring CD to meet specific treatment goals will keep your disease under control (remission) and decrease complications such as hospitalizations and surgeries. Group 1 treatment goals include IUS response (if the drug is improving your CD) and IUS assessed transmural healing (healing of all bowel layers), clinical remission (normalization of CD symptoms), and biomarker remission (improvement in stool and blood tests that show inflammation). Group 2 treatment goals include clinical remission and biomarker remission. Comparing the treatment goals in these groups may inform doctors how best to manage CD in the future. Approximately 304 people will be enrolled in this study. This research study will involve receiving 300 mg of vedolizumab as an intravenous (IV) infusion into your arm at Weeks 0, 2, 6, 10, and 14, then every 4 or 8 weeks thereafter.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu



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