Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects

Date Added
May 11th, 2021
PRO Number
Pro00105780
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 been diagnosed with an advanced type of Hodgkin lymphoma (HL) that hasn't been treated yet. Parts B and C are studying brentuximab vedotin given with 3 other drugs. Two of the drugs are chemotherapy drugs that have been used to treat cancer for a long time. One chemotherapy drug is called doxorubicin and the other is called dacarbazine. The third drug is an immunotherapy drug called nivolumab or Opdivo®. This will be the first time brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine have been tested together to treat HL. The primary purpose of this study is to assess the complete response (CR) rate (the disappearance of all signs of cancer in response to treatment) at End Of Treatment with the combination of drugs in subjects with previously untreated cHL .The subject may remain in the study for up to 2 years.

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

An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases

Date Added
April 27th, 2021
PRO Number
Pro00104445
Researcher
Michelle Hudspeth

List of Studies


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

This study is for children and adults that have been diagnosed with a disease that is associated with Epstein-Barr Virus (EBV) infection.The investigational treatment in this study is called tabelecleucel (also known as ATA129), this treatment is given in the vein. Participants will receive tabelecleucel on Day 1, Day 8 and Day 15 of every 35-day (5-week) period, the number of cycles depends on the response to treatment. The purpose of this study is to assess the safety of tabelecleucel and to assess the effects of tabelecleucel on EBV disease. Participants can expect to be in this study for about 2 years for an estimated 17-20 study visits.

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

COVID-19: A Mulicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with Acute Respiratory Distress Syndrome Associated with COVID-19

Date Added
April 8th, 2021
PRO Number
Pro00109695
Researcher
Andrew Goodwin

List of Studies


Keywords
Coronavirus, Drug Studies, Infectious Diseases, Lung, Pulmonary, SARS-CoV-2
Summary

TESICO (Therapeutics for Severely Ill Inpatients with COVID-19) is a master protocol to evaluate the safety and efficacy of investigational agents aimed at improving outcomes for patients with acute respiratory failure related to COVID-19.

Institution
MUSC
Recruitment Contact
Abigail Grady
843-792-2072
gradyabi@musc.edu

A Randomized, Double-blind, Placebo-Controlled, Active-Comparator, Multicenter, Phase 3 Study of Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Date Added
March 19th, 2021
PRO Number
Pro00105076
Researcher
Irl Greenwell

List of Studies


Keywords
Cancer, Cancer/Lymphoma, 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) that has come back or did not get better with your last treatment. The investigational drug in this study is brentuximab vedotin. The purpose of this study is to test if brentuximab vedotin, lenalidomide, and rituximab given together work to treat DLBCL and what the side effects are. Participants can expect to be in this study for up to 2.5 years.

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

A Proof of Concept, Split Study, Measuring the Effectiveness of Topical ProstaglandinF2alpha, Microneedling and Excimer Laser in the Treatment of Vitiligo.

Date Added
March 2nd, 2021
PRO Number
Pro00104695
Researcher
Joni Mazza-McCrann

List of Studies


Keywords
Cosmetic Procedures, Drug Studies, Ethnicity and Disease, Skin
Summary

The purpose of this research is to treat vitiligo with topical PGF2α, microneedling and excimer laser. The goal is to have greater repigmentation than the standard of care (excimer) after 12 weeks of treatment.

The study is a pilot, split study meaning the patient will receive one experimental and one standard of care treatment on symmetric lesions of similar location, geometrics and size.

Enrolled subjects will present biweekly to clinic for twelve weeks. One lesion will be treated with microneedling, topical PGF2α and calibrated excimer laser, while the parallel lesion will be excimer laser alone. Physical exam, photographs, and a review of of the subjects medical records will occur in the study. Changes in size, appearance, and adverse events will be monitored throughout the study. The patient will also agree to close up photographs of their lesions throughout the study.

The possible benefit of joining this study is that the treatment received may be more effective than the other study treatment or then other available treatments for vitiligo, although this cannot be guaranteed.

Institution
MUSC
Recruitment Contact
Gabriella Santa Lucia
7244138833
grs200@musc.edu

A Phase 1b Study of ASP1951, a GITR Agonistic Antibody, as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

Date Added
February 23rd, 2021
PRO Number
Pro00106203
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have a tumor that cannot be removed through surgery (unresectable) or may have spread (metastasized) to other parts of their body. In this study, ASP1951 will be given alone (monotherapy) or combined with pembrolizumab (combination therapy). Both ASP1951 and pembrolizumab will be considered study drug. Pembrolizumab has been approved by FDA for use in patients with skin, lung, cervical cancer, certain cancers of head and neck and other cancers but may not be approved to treat all types of cancer. However, the use of ASP1951 plus pembrolizumab has not been approved by regulatory authorities and is therefore investigational. The study consists of 3 periods: screening (up to 28 days), treatment (up to 48 weeks [16 cycles]) and follow up (up to 45 weeks), followed by an optional re-treatment period for participants that qualify. The re-treatment period will allow participants to receive study drug treatment again for up to 16 additional cycles (approximately 48 weeks), for a maximum total treatment and re-treatment period of 32 cycles (approximately 96 weeks). Both study drugs are administered intravenously (into the vein).This is the first time the investigational study drug ASP1951 is being tested in humans; however, studies in animals showed that the study drug is safe to be tested in humans.

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

A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination with Ruxolitinib in Subjects with Myelofibrosis (REFINE)

Date Added
February 23rd, 2021
PRO Number
Pro00106645
Researcher
Praneeth Baratam

List of Studies

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

This study is for subjects with Myelofibrosis. This study is testing an "investigational" (not yet FDA approved drug) drug called Navitoclax. The primary purpose of this study is to evaluate how well the study drug works alone OR in combination with ruxolitinib on spleen volume.The subject may remain in the study until the end of clinical benefit, occurrence of unacceptable side effects or discontinuation criteria have been met.

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

A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma

Date Added
February 23rd, 2021
PRO Number
Pro00105358
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 been diagnosed with a relapsed, progressive and/or refractory subtype of B-cell non-Hodgkin lymphoma (diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, high-grade B-cell lymphoma, marginal zone lymphoma, small lymphocytic lymphoma or follicular lymphoma). The investigational drug that will be tested is called GEN3013 (DuoBody®-CD3xCD20). The purpose of the trial is to investigate the safety, tolerability and efficacy of GEN3013 in subjects with different subtypes of B-cell non-Hodgkin lymphoma (referred to as B-cell NHL). Participants can expect to be in this study for 36 weeks of treatment, plus follow up until the disease progresses.

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

A Randomized, Double-Blind Placebo-Controlled, Phase 3 Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)

Date Added
February 17th, 2021
PRO Number
Pro00105934
Researcher
Anand Sharma

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). The investigational drug used in this study is Debio 1143. The main purpose of this study is to learn how well the study medicine works and how safe the study medicine is compared with placebo. A placebo is an inactive substance that looks like the study medicine but does not contain any active study medicine. Participants can expect to be in this study for up to 7 years. Participation will consist of approximately 56 visits at the study center over a period of 5 years, followed by telephone calls every 6 months over a period of maximum 2 years.

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

Pilot Trial of Belimumab in Early Lupus

Date Added
February 9th, 2021
PRO Number
Pro00104939
Researcher
Melissa Cunningham

List of Studies


Keywords
Drug Studies, Lupus
Summary

This is a study looking at the effects of Belimumab, a medication approved by the FDA to treat lupus, in people who have been recently diagnosed with lupus. It proposes that the early use of Belimumab may prevent long-term tissue damage from the disease. The study will last 2 years with clinic visits every 4 weeks.

Institution
MUSC
Recruitment Contact
Susannah Wakefield
843-792-5290
wakefies@musc.edu



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