A Phase 2 Randomized Study of Loncastuximab Tesirine Versus Idelalisib in Patients with Relapsed or Refractory Follicular Lymphoma (LOTIS 6)

Date Added
August 24th, 2021
PRO Number
Pro00112787
Researcher
Brian Hess

List of Studies


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

This study is for subjects that have relapsed or refractory follicular lymphoma, which means your lymphoma has worsened after treatment or has not responded to treatment. This study is testing an "investigational" (not yet FDA approved drug) study drug called loncastuximab tesirine (ADCT-402). Treatment will be administered intravenously or via tablet depending on the subject's assigned treatment. The primary purpose of this study is to test whether the investigational drug called loncastuximab tesirine may be more effective treatment for relapsed or refractory follicular lymphoma than treatment with the drug idelalisib. The subject will be seen approximately once every three weeks, and may remain in the study for up to 3 years.

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

A multi-center phase Ib trial evaluating the safety and efficacy of lacutamab in patients with relapse peripheral T-cell lymphoma that express KIR3DL2

Date Added
August 24th, 2021
PRO Number
Pro00113053
Researcher
Irl Greenwell

List of Studies


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

This study is for subjects that have been diagnosed with peripheral T-cell lymphoma (PTCL) and have received at least one prior systemic therapy for their disease. This study is testing an "investigational" (not yet FDA approved drug) study drug called Lacutamab (IPH4102). The primary purpose of this study is to evaluate the safety and effectiveness of lacutamab. The subject may remain in the study until their disease progresses or they have developed unacceptable toxicity secondary to lacutamab and can expect to be in follow-up for 1 year if they discontinue treatment in the first year.

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

Long-Term Nicotine Treatment of Mild Cognitive Impairment

Date Added
August 3rd, 2021
PRO Number
Pro00112159
Researcher
Jacobo Mintzer

List of Studies


Keywords
Aging, Alzheimers, Brain, Dementia, Drug Studies, Memory Loss
Summary

The purpose of the study is to see if daily use of nicotine patches will slow or reverse memory loss in participants with Mild cognitive impairment, an early stage of mental decline associated with Alzheimer's disease. Nicotine may mimic natural chemicals in the brain that play a crucial role in memory function, and previous studies have shown that nicotine may improve attention, learning, and memory. In this study, participants will receive either nicotine (up to 21mg/day, the standard dosage of a nicotine patch) or placebo for 2 years to see if these improvements in brain function can be observed over a longer period.

Institution
MUSC
Recruitment Contact
Allison Lapp
843-608-1950 x 1109
allisonlapp@lcvresearch.org

First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGFβ Fusion Protein BCA101 Alone and in Combination With Pembrolizumab in Patients With EGFR-Driven Advanced Solid Tumors

Date Added
July 27th, 2021
PRO Number
Pro00111442
Researcher
John Kaczmar

List of Studies


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

This study is for patients who have advanced cancers, such as head and neck cancer, colorectal cancer, breast cancer, and others. This study is testing a new treatment for these types of cancer. The new test drug is called BCA101. Pembrolizumab is an approved drug by the United States Food and Drug Administration (FDA) for the diseases described in this study and will be used as approved. The type of cancer a patient has will determine whether he/she will get BCA101 alone or BCA101 in combination with pembrolizumab. Participants will receive either BCA101 alone or BCA101 in combination with pembrolizumab until the cancer gets worse, they experience bad side effects, or until they withdraw consent, or until the Investigator considers it is in his/her best interest to discontinue the study drug.

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

MUSC Specialized Center of Research Excellence (SCORE) on Sex Differences: Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults

Date Added
July 23rd, 2021
PRO Number
Pro00111432
Researcher
Andreana Benitez

List of Studies


Keywords
Aging, Drug Studies
Summary

The goal of the study is to evaluate how cannabis use affects memory and thinking skills and response to stress in older adults. The study will also relate cannabis use to Alzheimer's Disease (AD) biomarkers (measurable substances in blood that indicate condition), and test whether sex and hormones play a role in these effects.

We are recruiting adults between the ages of 50 and 80 who use cannabis products on a regular basis. This study is being conducted by Dr. Andreana Benitez at the Departments of Neurology and Psychiatry at the Medical University of South Carolina (MUSC) and will involve approximately 40 volunteers. Study participation will last about two weeks.

Institution
MUSC
Recruitment Contact
Katrina Madden
843-792-9186
maddenka@musc.edu

Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) Study

Date Added
July 21st, 2021
PRO Number
Pro00112140
Researcher
Jacobo Mintzer

List of Studies


Keywords
Aging, Alzheimers, Brain, Dementia, Drug Studies, Memory Loss
Summary

The purpose of this study is to test whether an investigational drug called solanezumab can slow the progression of memory problems associated with brain amyloid (protein that forms plaques in the brains of people with Alzheimer Disease [AD]).

Institution
MUSC
Recruitment Contact
Allison Lapp
843-608-1950 x 1109
allisonlapp@lcvresearch.org

A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid

Date Added
July 13th, 2021
PRO Number
Pro00110190
Researcher
Don Rockey

List of Studies


Keywords
Drug Studies, Liver, Rare Diseases
Summary

This is an experimental drug trial to study a new drug, elafibranor, in patients with Primary Biliary Cholangitis (PBC). The main objective of this study is to evaluate the effect of daily oral 80mg elafibranor for 52 weeks on the treatment of cholestasis (impairment of bile formation and/or bile buildup) in patients with PBC. Elafibranor is a medicine being developed by Genfit Pharmaceuticals that is designed to work differently than any other available medications for PBC. In addition to decreasing bile acid formation, increasing bile acid uptake, and detoxifying bile acids like medications that work similarly to elafibranor, elafibranor additionally has anti-inflammatory effects that Genfit believes will provide additional health benefits to patients with PBC.

Persons interested in participation will need to complete at least 1, but no more than 3, Screening Visits at the Main Campus of the Medical University of South Carolina (MUSC) in Charleston, SC in order to determine eligibility. If enrolled, you will have up to 21 study visits with the study doctor at MUSC over a period of at least 52 weeks (1 year) and up to a maximum of 312 weeks (6 years). At study visits you will be asked to complete up to 7 study-related questionnaires and complete any study-related testing such as physical exams, medical imaging, lab work (such as blood or urine tests), etc.

Institution
MUSC
Recruitment Contact
Joshua Inman
843-876-4303
inmanj@musc.edu or liverstudies@musc.edu

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

Date Added
July 6th, 2021
PRO Number
Pro00111013
Researcher
Leslie Lenert

List of Studies


Keywords
COVID-19, Coronavirus, Drug Studies, Infectious Diseases, SARS-CoV-2
Summary

This study will repurpose medications that have already been approved for use by the Food and Drug Administration (FDA) for other indications to treat non-hospitalized patients that are at least 30 years old with mild to moderate COVID-19. The effectiveness of reducing COVID-19 symptoms will be evaluated by comparing the medication to a placebo or fake treatment with no therapeutic value. Participation will last about 90-days and all study visits are designed to be performed over the phone or remotely. Participants will be compensated for their time and participation in this research study.

Institution
MUSC
Recruitment Contact
Elizabeth Szwast
843-792-4675
hinsone@musc.edu

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY ON THE SAFETY AND EFFICACY OF ISTAROXIME FOR PRE-CARDIOGENIC SHOCK (SEISMiC)

Date Added
June 22nd, 2021
PRO Number
Pro00107597
Researcher
Adrian Van Bakel

List of Studies


Keywords
Drug Studies, Heart
Summary

This study is for patients who are currently hospitalized with heart failure, a condition where the heart muscle is weakened and cannot pump blood effectively, and have low blood pressure. This study involves an investigational, not yet approved by the US Food and Drug Administration (FDA) intravenous (given into a vein) medication that is being studied to see if it can help increase blood pressure. The study involves a screening visit, randomization which is where either the study medication or placebo is assigned randomly, medication or placebo infusion for 24 hours, visits at day 2,3 and 4 and then a final visit at day 30.

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
843-792-0464
panneeer@musc.edu

A Phase 3 Randomized Study of Loncastuximab Tesirine Combined with Rituximab Versus Immunochemotherapy in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Date Added
June 3rd, 2021
PRO Number
Pro00106658
Researcher
Brian Hess

List of Studies


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

This study is for subjects that have been diagnosed with diffuse large B-cell lymphoma (DLBCL), a type of non-Hodgkin lymphoma (NHL) that has gotten worse or come back after treatment. This study is testing an "investigational" (not yet FDA approved) study drug called Loncastuximab Tesirine. The primary purpose of this study is to evaluate the efficacy of loncastuximab tesirine combined with rituximab compared to standard immunochemotherapy. The subject may remain in the study for up to 5 years, 28 days for screening period, a 16-25 week treatment period, and a follow-up period of 4 years.

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



-- OR --