Expanded Access Protocol (EAP) for Subjects Receiving Lisocabtagene Maraleucel That is Nonconforming for Commercial Release

Date Added
May 11th, 2021
PRO Number
Pro00107699
Researcher
Brian Hess

List of Studies


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

This study is for patients who have been diagnosed with relapsed (came back) and/or refractory (not responding to treatment) large B-cell lymphoma (LBCL). The investigational product is Lisocabtagene Maraleucel and is administered by infusion. Participants will have had the blood collection (leukapheresis - a laboratory procedure where white blood cells are separated from a sample of blood) procedure, where the T cells (white blood cells) were collected and genetically modified in a laboratory in order to manufacture the lisocabtagene maraleucel T cells for disease treatment. The lisocabtagene maraleucel T cells that were produced do not meet all of the prespecified release criteria to be used as a routine prescription drug as required by the Food and Drug Administration (FDA). This is called a nonconforming lisocabtagene maraleucel. The purpose of this study is to allow participants to be treated with their nonconforming lisocabtagene maraleucel. Participants can expect to be on the study for up to 3 months following the infusion of nonconforming lisocabtagene maraleucel.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
HCC-Clinical-Trials@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

A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Heart Valve System in the Treatment of High Surgical Risk Patients with Symptomatic, Severe Aortic Regurgitation (AR)

Date Added
December 14th, 2021
PRO Number
Pro00116082
Researcher
Nicholas Amoroso

List of Studies


Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System in a patient population with symptomatic severe Aortic regurgitation ( a condition where the heart's aortic valve does not close tightly and allows some blood to leak back into the heart chamber) requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR).

Your involvement in this study will last approximately 5 years from the time of your procedure. The visits include: Screening/Baseline, Procedure, Pre-Discharge, 1 month, 6 months and annualy for 5 years

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination with Other Anti-cancer Agents in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

Date Added
December 14th, 2021
PRO Number
Pro00116496
Researcher
Brian Hess

List of Studies


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

This study is for subjects with Diffuse large B-cell lymphoma (DLBCL) that has gotten worse or come back after two or more treatments. 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 combination of loncastuximab tesirine in combination with one of four other anti-cancer agents is a safe and effective treatment for relapsed or refractory B-cell Non-Hodgkin Lymphoma. Treatment will be assigned by a system in a sequence unless the subject has received the combination drug (the drug that is not locastuximab). This means the first enrolled subject will be assigned to arm C, the second to arm E, and so on. The subject will be seen approximately once a week during treatment, 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 Phase 1/2 Study to Evaluate the Safety and Efficacy of a Single Dose of Autologous Clustered Regularly Interspaced Short Palindromic Repeats Gene-edited CD34+ Human Hematopoietic Stem and Progenitor Cells (EDIT-301) in Subjects with Severe Sickle Cell Disease

Date Added
February 8th, 2022
PRO Number
Pro00106939
Researcher
Jennifer Jaroscak

List of Studies


Keywords
Transplant
Summary

This is a research study to find out if a study drug called EDIT-301 is safe and effective in treatment of patients with severe Sickle Cell Disease (SCD). The EDIT-301 study medicine is a new investigational therapy, which in this case means this is first-in-human use of this study drug. This study medication uses patients' own stem cells, modifies the cells with genetic modification, and transplants them back to the patient (by infusion) to treat SCD.
Participation in this study is expected to last approximately 30 months, including time for screening, collection of cells, transplant, and a 24 month follow-up period after transplant. At the end of that 24 month follow-up, the participant will be asked to participate in an additional long-term follow-up study, totaling 15 years of post-transplant follow-up.

Institution
MUSC
Recruitment Contact
Brandi Day
843-792-3379
dayb@musc.edu

The BEST Trial: Biomarkers for Evaluating Spine Treatments

Date Added
May 17th, 2022
PRO Number
Pro00117916
Researcher
Kelly Barth

List of Studies


Keywords
Drug Studies, Exercise, Pain, Physical Therapy
Summary

The purpose of this research study is to study four treatments for chronic low-back pain to learn whether or not certain treatments work better for people with certain characteristics.The study's main goal is to find a way to match treatments to low-back pain patients based on their characteristics and how they responded to treatments they have used before.

This study is a multi-site, sequential, multiple assignment randomized trial (SMART) designed to meet the primary objective of estimating an algorithm for optimally assigning evidence-based interventions for chronic low-back pain. The trial is based on an individual patient's phenotypic markers and response to treatment. Interventions being evaluated in this trial are: (1) acceptance and commitment therapy (ACT), (2) duloxetine, (3) enhanced self-care (ESC), and (4) evidence-based exercise and manual therapy (EBEM).

Institution
MUSC
Recruitment Contact
Haley Schiek
843-764-7309
schiek@musc.edu

Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥65 Year-olds (PRIMARY)

Date Added
May 17th, 2022
PRO Number
Pro00119787
Researcher
Marc Katz

List of Studies


Keywords
Heart, Surgery
Summary

The purpose of this research is to compare the risks and benefits of two different procedures used to help patients with mitral valve regurgitation (also known as MR). MR is a condition where the valve does not close fully when it is supposed to, and some blood can then leak back into the left atrium instead of circulating to the rest of the body. The treatment options this study will compare are: (1) transcatheter edge-to-edge repair (abbreviated as TEER; which is a catheter procedure for repairing the mitral valve that doesn't require surgery to open up the heart) and (2) mitral valve repair surgery, which is an open-heart surgical procedure. There are no new or "experimental" procedures being tested in this study: both treatment options are well-established treatments and are regularly performed in patients who have MR.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients with Post-ProstaTEctomy Biochemical Recurrence (INDICATE)

Date Added
August 5th, 2022
PRO Number
Pro00122143
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer/Genitourinary, Prostate
Summary

This study is for men with prostate cancer that has come back after surgery. This study is being done to see if PET/CT scans help provide more tailored treatment recommendations and outcomes for men who have prostate cancer after radical prostatectomy (RP) and will adding focal, metastasis directed radiation treatment (e.g.., stereotactic radiation) and/or additional systemic therapy (e.g., apalutamide) to standard of care treatment help to delay progression of prostate cancer in men who have already had an RP and now have recurrence?

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

MEPITEL FILM FOR THE REDUCTION OF RADIATION DERMATITIS IN BREAST CANCER PATIENTS UNDERGOING POST-MASTECTOMY RADIATION THERAPY: A RANDOMIZED PHASE III CLINICAL TRIAL

Date Added
August 15th, 2022
PRO Number
Pro00122724
Researcher
Jennifer Harper

List of Studies


Keywords
Cancer/Breast
Summary

This study is for patients who have been diagnosed with breast cancer and their doctor has recommended that they receive radiation therapy after their mastectomy to reduce the risk of their breast cancer coming back. This study is being done to see if the severity of skin redness and peeling in the area of radiation can be reduced by applying Mepitel Film during radiation therapy.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
broe@tidelandshealth.org

A Phase 1B Dose Escalation Study Of Metabolically Fit CD19 Chimeric Antigen Receptor (CAR) T Cells With CD34 Selection Markers In Adult Patients With Relapsed Or Refractory CD19 B- Cell Non-Hodgkin Lymphoma And Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Date Added
August 16th, 2022
PRO Number
Pro00121846
Researcher
Brian Hess

List of Studies


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

This study is for adult male and female subjects that have been diagnosed with B-cell leukemias and lymphomas. In this research study, some of the subjects immune cells (called T cells) will be taken during a procedure called ‘apheresis', and genetically modified in the laboratory, in order to recognize a protein on the cancer cells. The investigational treatment in this study is called CD19-CD34t metabolically programmed CAR-T cells. The purpose of this study is to test whether these genetically CD19-CD34 CAR T-cells when re-introduced back into the body, will be able to safely and effectively attack the cancer cells. The investigators also want to determine the dose of genetically modified CD19-CD34 CAR T-cells which can be safely administered to subjects. Subjects can expect to be in this study for up to 15 years.

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



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