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

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

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

PARALLEL PHASE III RANDOMIZED TRIALS FOR HIGH RISK PROSTATE CANCER EVALUATING DE-INTENSIFICATION FOR LOWER GENOMIC RISK AND INTENSIFICATION OF CONCURRENT THERAPY FOR HIGHER GENOMIC RISK WITH RADIATION (PREDICT-RT*)

Date Added
March 4th, 2021
PRO Number
Pro00108846
Researcher
David Marshall

List of Studies


Keywords
Cancer/Genitourinary, Hormones, Men's Health, Prostate
Summary

This study is for men who have high-risk prostate cancer who plan to be treated with a combination of radiation and hormonal therapy. A tumor genomic analysis (Decipher score) will be used to divide the subjects into two groups. Those with a low genomic risk score will be randomized to either standard treatment with radiation and 24 months of hormonal therapy or to radiation with a shorter, 12 month, course of hormone therapy. Those with a higher genomic risk score or who have lymph node involvement will be randomized to standard treatment with radiation and 24 months of standard hormonal therapy or radiation with 24 months of intensified hormonal therapy.

Institution
MUSC
Recruitment Contact
Amanda Kelley
(864) 725-7125
amanda.kelley@selfregional.org

PARALLEL PHASE III RANDOMIZED TRIALS FOR HIGH RISK PROSTATE CANCER EVALUATING DE-INTENSIFICATION FOR LOWER GENOMIC RISK AND INTENSIFICATION OF CONCURRENT THERAPY FOR HIGHER GENOMIC RISK WITH RADIATION (PREDICT-RT*)

Date Added
March 4th, 2021
PRO Number
Pro00108846
Researcher
David Marshall

List of Studies


Keywords
Cancer/Genitourinary, Hormones, Men's Health, Prostate
Summary

This study is for men who have high-risk prostate cancer who plan to be treated with a combination of radiation and hormonal therapy. A tumor genomic analysis (Decipher score) will be used to divide the subjects into two groups. Those with a low genomic risk score will be randomized to either standard treatment with radiation and 24 months of hormonal therapy or to radiation with a shorter, 12 month, course of hormone therapy. Those with a higher genomic risk score or who have lymph node involvement will be randomized to standard treatment with radiation and 24 months of standard hormonal therapy or radiation with 24 months of intensified hormonal therapy.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Amanda Kelley
(864) 725-7125
amanda.kelley@selfregional.org

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 Phase 2, Open-Label, Multi-Center Study of PDS0101 (R-DOTAP [Versamune®] + HPVmix) and Pembrolizumab (KEYTRUDA®) Combination Immunotherapy in Subjects with Recurrent and/or Metastatic Head and Neck Cancer and High-Risk Human Papillomavirus-16 (HPV16) Infection

Date Added
February 9th, 2021
PRO Number
Pro00101695
Researcher
John Kaczmar

List of Studies


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

This study is for patients who have been diagnosed with Head and Neck Cancer that spread to sites distant from the head and neck region (metastatic) or for cancer that returned or got worse after being treated (recurrent), and test positive for High-risk Human Papillomavirus-16 (HPV16) Infection.

The investigational vaccine in this study is called PDS0101. "Investigational" means the study vaccine being tested has not been approved by the United States Food and Drug Administration (FDA). The purpose of this research is to find out if the combination of the investigational vaccine, given by subcutaneous (beneath the skin) injection and the standard of care, Pembrolizumab (KEYTRUDA®), given by IV, are effective and safe. The PDS0101 vaccine designed to boost the body's immune response against HPV 16.Participants can expect to receive treatment for about 2 years. Each person who agrees to take part in the study will be asked to come in for a minimum of 18 cycles and a maximum of 35 cycles.

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

A Phase 2, randomized, open-label three-arm clinical study to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3475) versus standard of care chemotherapy and lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and immunotherapy (PD-1/PD-L1 inhibitors) (LEAP-009)

Date Added
February 1st, 2021
PRO Number
Pro00101229
Researcher
John Kaczmar

List of Studies


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

This study is for patients who have been diagnosed with head and neck squamous cell carcinoma (HNSCC) that has returned (recurrent) or spread after previous treatment (metastatic). The investigational drug in this study is lenvatinib. The study will also use lenvatinib in combination with pembrolizumab, which is also experimental. The purposes of this study are to: test the safety of the study drugs, lenvatinib alone, pembro and lenvatinib together, and standard chemotherapies alone in the treatment of HNSCC; see how well the combination of pembro and lenvatinib works, compared to standard chemotherapies; and see if participants who get pembro and lenvatinib live longer than those who are treated with standard chemotherapies. Participants can expect to be on this study for about 48 months.

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

Pulmonary Vascular Complications of Liver Disease 3 (PVCLD3)

Date Added
January 22nd, 2021
PRO Number
Pro00103260
Researcher
David Koch

List of Studies


Keywords
Hypertension/ High Blood Pressure, Liver, Men's Health, Pulmonary, Transplant, Vascular
Summary

This is a prospective cohort study of subjects with portal hypertension to examine whether increased sphingosine 1 phosphate : ceramide ratio and circulating bile acids are associated with HPS in patients with advanced liver disease. The study will consist of 400 individuals who are evaluated for liver transplantation at the Field Centers. This population has advanced liver disease and will represent the population with cirrhosis at the Centers. As is considered standard of clinical care for these patients and required for liver transplant evaluation, patients will undergo phlebotomy, interviews, pulmonary function testing, echocardiography, and arterial blood gas sampling at their initial evaluation. During the clinical phlebotomy, additional samples will be drawn for research purposes. If any of these procedures does not occur during the clinical visit, it may be conducted for research purposes. Six minute walk testing, frailty scales, SF36, and optional actigraphy, all of which are research-only assessments, will be performed at baseline. Subjects will then be followed via phone for the duration of the study period.

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

Phase 1/2, Double-Blind, Placebo-Controlled, Dose Escalation and Expansion Study of ALVR106 in Addition to Standard of Care for the Treatment of High-Risk Patients with Respiratory Viral Infections After Hematopoietic Stem Cell or Solid Organ Transplant

Date Added
January 12th, 2021
PRO Number
Pro00103083
Researcher
Michelle Hudspeth

List of Studies


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

This study is for patients who have been diagnosed with a respiratory viral infection, like respiratory syncytial virus (RSV), influenza, human metapneumovirus, and/or parainfluenza virus, after a hematopoietic cell transplant. The investigational drug in this study is ALVR106. The purpose of this study is to determine if ALVR106 is safe and to determine the best dose (amount) for treating respiratory infections. Participants can expect to be in this study for approximately 1 year.

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



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