RELIANCE: A phase 1, randomized, double-blinded, placebo-controlled, trial evaluating the long-term safety and tolerability of Imatinib for the treatment of Lymphangioleiomyomatosis (LAMP-2 Trial)

Date Added
July 30th, 2024
PRO Number
Pro00136539
Researcher
Charlie Strange

List of Studies


Keywords
Kidney, Lung, Pulmonary, Rare Diseases, Women's Health
Summary

The purpose of this medical research study is to evaluate the safety and effectiveness of a new medication called imatinib mesylate in the treatment of Lymphangioleiomyomatosis (LAM). LAM is a rare disease in which abnormal cells (called LAM cells) grow out of control. Over time, LAM cells destroy healthy lung tissue and cause respiratory disease or failure.

Many patients with LAM are currently treated with a medication called sirolimus (rapamycin). Sirolimus slows the growth of LAM cells.

Imatinib mesylate (hereafter called imatinib) is approved by the Food and Drug Administration (FDA) for the treatment of some cancers that share common pathways with LAM cells. Laboratory studies suggest that imatinib could completely block the growth of LAM cells through initiation of targeted cell death.

An important purpose of this research is to determine the safety of imatinib in people with LAM. This study will also evaluate the short-term effectiveness of imatinib. Participants will be randomized to receiving imatinib (study medication) or placebo (no treatment) for the 180 day duration of participation. The study is being conducted at the Medical University of South Carolina and at Columbia University in New York (CUMC). Each site will enroll 10 participants.

Institution
MUSC
Recruitment Contact
Mary Hayden
(843) 792-8438
blantonm@musc.edu

Out-of-State, At-Home, Transcutaneous Auricular Neuromodulation for Hypermobile Ehlers Danlos Syndrome

Date Added
August 6th, 2024
PRO Number
Pro00138254
Researcher
Jeffrey Borckardt

List of Studies


Keywords
Brain
Summary

Hypermobile EDS and hypermobile spectrum disorder (collectively referred to as hEDS) are estimated to affect 1 in 500 individuals worldwide. This study will enroll hEDS patients to test a new ear stimulation system to help reduce symptoms associated with hEDS, including pain and GI problems. Ear stimulation will be applied twice daily, for four weeks at home, and we will collect electronic behavioral data to track progress.

Institution
MUSC
Recruitment Contact
Katherine Tucker
843-792-9502
tuckekat@musc.edu

A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)

Date Added
August 9th, 2024
PRO Number
Pro00133370
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 Follicular Lymphoma.
This study is testing an investigational drug(s) called Epcoritamab that is not approved by the FDA (Food and Drug Administration). The purpose of this study is to see if the combination of the study drug epcoritamab with rituximab and lenalidomide has a better response rate than standard of care chemoimmunotherapy in the treatment of follicular lymphoma. The total study treatment duration is up to 2.5 years. You may stop the study treatment early if you do not respond after 6 months, your disease worsens, you no longer tolerate the study drug(s), or you withdraw from the study.

Once you finish the study treatment or discontinued study treatment early, you will continue to the Post-Study Treatment Follow Up Period, you will come back to the study clinic every 6 months for the first 3 years and then yearly to have imaging scans and blood work to check if your disease is in remission or worsen.

If your disease worsens or if you start a new FL treatment, you will enter the Long-term Follow Up Period, you will be called by telephone or your health record will be reviewed to check on your well-being and to see what your next treatment plan will be. This follow-up may last up to 15 years.

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

Health Outcomes of Parents with Cystic Fibrosis (HOPe:CF) Aim 2

Date Added
August 13th, 2024
PRO Number
Pro00136818
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis
Summary

We will follow 146 new parents of children <5 years of age at 18 participating US
adult CF centers to assess the primary outcome of ppFEV1 up to 5 years after
becoming a parent. A prospective approach will capture the immediate and longterm impact of the use of the highly effective CFTR modulator ETI by ~90% of US
adults with CF. By combining objective health measures and participant surveys,
we can comprehensively assess the psychosocial impacts of parenthood and
explore the interplay between the parenting role and physical and mental health.
We anticipate identifying modifiable factors that may ameliorate negative health
impacts of parenthood.

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

ACCESS BNP CLINICAL SUBJECT SAMPLE COLLECTION ENROLLMENT STUDY PROTOCOL

Date Added
August 14th, 2024
PRO Number
Pro00138430
Researcher
Gary Headden

List of Studies


Keywords
Cardiovascular
Summary

The purpose of this study is to collect blood specimens and determine the levels of natriuretic peptides in the blood in patients that are presenting with a suspicion of new onset or worsening symptoms of heart failure. Blood specimens collected during this study will be used to support expanded development of a blood test that can help physicians diagnose heart failure.

The blood test (Access BNP Assay) being developed will measure natriuretic peptides that are released into the blood when the heart muscle is stretched and working too hard. This information is being used to develop a better blood test(s).

Institution
MUSC
Recruitment Contact
Paige Hall
8437927944
hallpai@musc.edu

A Global Pivotal Study in Patients with KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of Pembrolizumab and LY3537982 vs Pembrolizumab and Placebo in those with PD-L1 50% or Pembrolizumab, Pemetrexed, Platinum Chemotherapy and LY3537982 vs Pembrolizumab, Pemetrexed, Platinum Chemotherapy and Placebo regardless of PD-L1 Expression

Date Added
September 5th, 2024
PRO Number
Pro00135211
Researcher
Mariam Alexander

List of Studies

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

Study JZQB is a global research effort investigating a potential treatment for lung cancer. The study involves patients with a specific type of lung cancer that has certain genetic features. Researchers aim to compare the effectiveness of a new drug, LY3537982, when used in combination with pembrolizumab, against a placebo combined with pembrolizumab. The goal is to understand how well the new drug combination works in preventing the cancer from returning and whether it improves patients' overall quality of life. The study is carefully designed to align with real-world medical practices and will evaluate different doses of the new drug. It emphasizes safety, efficacy, and patient outcomes to provide valuable insights for future lung cancer treatments.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinicaltrials@musc.edu

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to evaluate Dostarlimab as Sequential Therapy after Chemoradiation in Participants with Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

Date Added
October 25th, 2024
PRO Number
Pro00136526
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Drug Studies
Summary

This phase III study evaluates whether a new drug, dostarlimab, can delay or reduce the risk of cancer returning when administered for a year, shortly after receiving a combination of radiotherapy and chemotherapy (CRT). This study will enroll adults diagnosed with head and neck cancer who are treated with CRT. This study is divided into three parts: the screening period begins shortly after CRT and lasting 4-6 weeks where tests will be conducted to determine eligibility, followed by a 12-month treatment period where participants will receive either dostarlimab or an inactive substance (salt solution) with no effect on your body (placebo), and a follow up period when they will continue to be assessed to see if their cancer has returned or gotten worse. Participants may be on the study for approximately up to 5 years in total. The main risks are anaemia, nausea, vomiting, and diarrhea. Alternatives to this treatment is standard of care CRT because for this type of head and neck cancer, at the present time, there are no other approved therapies administered shortly after CRT that may prevent or delay the return of the cancer. The study benefit is dostarlimab may help slow or stop the growth of your cancer.

Institution
MUSC
Recruitment Contact
HCC clinical trails office
843-792-9321
hcc-clinicaltrials@musc.edu

Phase 3 Randomized Open-label Study of Adjuvant Pembrolizumab W/WO MK2870 in Resectable Stages II-IIIB(N2) NSCLC for Patients not AchievingpCR After Receiving Neoadjuvant Pembrolizumab with Platinum-Based Doublet Chemotherapy Followed by Surgery

Date Added
October 31st, 2024
PRO Number
Pro00138712
Researcher
Mariam Alexander

List of Studies

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

This research study is testing a new treatment plan for patients with a type of lung cancer that can be surgically removed. The study focuses on patients who have not had complete success with initial treatments before surgery. The treatment plan includes a combination of chemotherapy and a drug called pembrolizumab before surgery, followed by surgery to remove the cancer, and then more pembrolizumab with or without another drug called MK-2870 after surgery.

The goal is to see if adding MK-2870 can help improve the chances of recovery and prevent the cancer from coming back in patients who didn't respond fully to the initial treatment. This study aims to find better ways to treat lung cancer and improve the survival rates of these patients.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinicaltrials@musc.edu

Impacts of drug abuse-mediated inflammatory perturbations on affinity maturation of anti-CD4 autoantibodies and poor immune reconstitution from ART in HIV

Date Added
November 6th, 2024
PRO Number
Pro00140552
Researcher
Wei Jiang

List of Studies


Keywords
Drug Studies, HIV / AIDS
Summary

This study is to understand HIV-infected cocaine users have poor immunity after anti-HIV treatment, but HIV-infected cannabis users are likely different. Cocaine use always is associated high inflammation and cannabis use is associated with low inflammation. We study how inflammation cannot be controlled in cocaine users; our goal is to develop new therapies to help cocaine users to have a better health and immunity.

Institution
MUSC
Recruitment Contact
Wei Jiang
8438762457
jianw@musc.edu

A Randomized Phase II Study of Tepotinib with or without Ramucirumab in Participants with MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)

Date Added
November 7th, 2024
PRO Number
Pro00140795
Researcher
Christopher Rangel

List of Studies

Keywords
Cancer/Lung
Summary

This phase II Expanded Lung-MAP treatment trial tests tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after a period of improvement (recurrent). Tepotinib is used in patients whose cancer has a mutated (changed) form of a gene called MET. It is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal MET protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving tepotinib with ramucirumab may lower the chance of the cancer from growing or spreading in patients with stage IV or recurrent non-small cell lung cancer.

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



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