A Randomized Phase II Study Comparing Inotuzumab plus Chemotherapy versus Standard Chemotherapy in Older Adults with Philadelphia-Chromosome Negative B-Cell Acute Lymphoblastic Leukemia (ALL)

Date Added
May 18th, 2023
PRO Number
Pro00128781
Researcher
Alexander Coltoff

List of Studies

Keywords
Cancer, Cancer/Leukemia
Summary

This trial will enroll patients 50 years and older with acute lymphoblastic leukemia (ALL). Patients above age 50 years are not eligible for intensive chemotherapy regimens and have been shown to have worse outcomes than adolescents and young adults treated with the same chemotherapy. For instance, the 5-year survival for patients aged 55-65 years treated on an international ALL trial was 21% compared to 38% for younger patients. Similarly, the 5-year survival for patients treated at MD Anderson Cancer Center with the hyper-CVAD regimen was 30% for patients aged 40-59 years compared to 51% for those less then age 40 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
(843)792-9371
hcc-clinical-trials@musc.edu

A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer" (HERO)

Date Added
May 17th, 2023
PRO Number
Pro00128928
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer/Breast
Summary

This study is for people with low-risk HER-2 positive breast cancer. The study is being done to see if treatment with HER2-targeted therapy without radiation therapy as good as the usual treatment of radiation and HER2-targeted therapy in patients who have had surgery, chemotherapy, and HER2-targeted therapy.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-7929321
hcc-clinical-trials@musc.edu

A Phase 2b Randomized, Double-blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

Date Added
May 17th, 2023
PRO Number
Pro00128120
Researcher
Erin Forster

List of Studies


Keywords
Ulcerative colitis
Summary

This is a randomized, double-blind, active- and placebo-controlled, parallel group, multicenter study to evaluate the efficacy and safety of induction and maintenance JNJ-78934804 therapy in participants 18 to 65 years of age (inclusive, at the time of consent), with moderately to severely active UC as determined by a modified Mayo score ≥5 and a final reported endoscopy subscore ≥2 obtained during the central review of the screening video endoscopy. Participants must also have demonstrated an inadequate initial response, loss of response, or intolerance to ≥1 approved ADT (advanced therapy inadequate responder [ADT-IR]). Overall, the study will evaluate 48 weeks of therapy with JNJ-7893480. The primary objective of the study is to evaluate the efficacy of JNJ-78934804 at Week 48
compared with each monotherapy (guselkumab alone and golimumab alone).

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

A Multi-Center, Phase 3, Randomized Trial of Matched Unrelated Donor (MUD) versus HLAHaploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) with Acute Leukemia or Myelodysplastic Syndrome (MDS)

Date Added
May 16th, 2023
PRO Number
Pro00128723
Researcher
Michelle Hudspeth

List of Studies


Keywords
Adolescents, Cancer/Leukemia
Summary

This study is for patients with acute leukemia or myelodysplastic syndrome (MDS). This study is being done to help understand whether a haplo related donor or a MUD HCT for people with acute leukemia or MDS is better or if there is no difference at all.

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

Accelerated rTMS for Post-Stroke Apathy: Targeting Amotivation Toward Improving Whole Health and Rehabilitation Engagement

Date Added
May 16th, 2023
PRO Number
Pro00126436
Researcher
Parneet Grewal

List of Studies

Keywords
Depression, Memory Loss, Stroke, Stroke Recovery
Summary

Apathy is a common set of symptoms seen in many people following a stroke. Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them. Apathy has a large negative impact on a person's quality of life, and can also have a large impact the people who take care of individuals with apathy. There are currently no FDA-approved treatments to help with apathy, and other services like therapy may be difficult to access for people who have had a stroke. To address this problem, we are conducting a study to find out if a form of treatment called repetitive transcranial magnetic stimulation (rTMS) can be safe and helpful for people struggling with apathy after a stroke. Our study will apply a new form of rTMS which can be delivered quickly to a part of the brain called the medial prefrontal cortex (mPFC). Our study will help establish whether this treatment is safe, comfortable, and effective for people with apathy after a stroke, and will help researchers develop new forms of treatment.

Institution
MUSC
Recruitment Contact
Lisa McTeague
843-792-8274
mcteague@musc.edu

UF-HN-004 Risk Adapted De-Intensification of Radio-Chemotherapy for Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma based on HPV subtype and plasma circulating free HPV DNA Level and Clearance Rate.

Date Added
May 16th, 2023
PRO Number
Pro00124145
Researcher
Bhishamjit Chera

List of Studies

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

This study is for patients that have been diagnosed with Oropharyngeal Squamous Cell Carcinoma. The purpose of this research study is to determine if lower doses of radiation therapy are as effective as the standard higher doses. Participants will have tests and procedures that would be performed as part of regular care. Participants will be assigned to one of three study groups based on your risk for cancer recurrence. Depending on the group assigned, participants receive either standard dose of radiation therapy (RT), a moderately reduced dose of RT, or an extremely reduced dose of RT. During the RT treatment, participants will also receive chemotherapy. Chemotherapy will be given at the same dose used in routine care for everybody in the study. Participants will be in the study for up to 5 years.

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

Occult Gastrointestinal Bleeding Caused by Portal Hypertensive Gastropathy in Patients with Cirrhosis

Date Added
May 11th, 2023
PRO Number
Pro00121305
Researcher
Don Rockey

List of Studies


Keywords
Digestive System, Liver, Stomach
Summary

In this study, we will recruit cirrhotic patients who are undergoing endocscopic procedures as part of their standard of care. Their endoscopies will reveal whether they have portal hypertensive gastropathy. After the procedure, we will ask the patients to provide us with a stool sample, which we will assess for occult GI bleeding. For those patients who DO NOT have occult GI bleeding, they will be contacted every 6 months for 2 years to check whether they have developed GI bleeding.

Institution
MUSC
Recruitment Contact
Sara Hatoum
843 792 0650
hatoum@musc.edu

PULMONARY EMBOLISM – THROMBUS REMOVAL WITH CATHETER-DIRECTED THERAPY: THE PE-TRACT TRIAL

Date Added
May 10th, 2023
PRO Number
Pro00127854
Researcher
Kevin Dickey

List of Studies

Keywords
Lung, Pulmonary
Summary

This is a study to determine effectiveness of using catheter directed therapy along with medical directed therapy when treating pulmonary embolism versus using medical directed therapy alone.

Institution
MUSC
Recruitment Contact
Samuel Bidwell
843-792-2305
bidwells@musc.edu

A Randomized Trial of Cryoprobe Versus Forceps for Transbronchial Biopsy (FROSTBITE-2)

Date Added
May 9th, 2023
PRO Number
Pro00124571
Researcher
Christopher Gilbert

List of Studies

Keywords
Cancer, Lung, Pulmonary
Summary

This study is for patients scheduled for a bronchoscopy procedure for evaluation of lung transplantation, lung disease, and lung nodules. Those who give consent to participate in this study will be randomized into one of two lung biopsy sampling method groups: Group 1) 1.1 mm single-use Cryoprobe or Group 2) conventional 2.0 mm forceps. These devices are used with a bronchoscope to obtain lung tissue biopsy samples and are being evaluated to determine which is better for confirming a diagnosis. All procedures will be done via standard of care and screening will be accomplished via medical chart review. Subjects will have two in-person appointments and one follow-up telephone call. The first of which is their standard of care office visit with the doctor to go over their plan of care. The second visit is for the standard of care bronchoscopy procedure to obtain biopsy samples. Thirty days following the procedure, a member of the study team will call the subject to assess whether any adverse events may have occurred since the procedure.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
balassom@musc.edu

Southeastern Consortium for Lung Cancer Health Equity (SC3) Biospecimen Repository

Date Added
May 8th, 2023
PRO Number
Pro00128239
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is designed to collect saliva and blood samples from subjects going through the Lung Cancer Screening Program to compare biomarker test results to develop lung cancer clinical risk prediction models further. Also, this study will store blood samples in a biorepository.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu



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