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

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 Cell 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

Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation (BMT CTN 1702)

Date Added
November 16th, 2020
PRO Number
Pro00103794
Researcher
Michelle Hudspeth

List of Studies


Keywords
Cancer, Transplant
Summary

This study is for participants that require an allogeneic stem cell transplant in the next 6 months. The purpose of this study is to see if there is a difference in how people do if they are very likely or very unlikely to find an HLA-matched unrelated donor. Depending on whether the participant is very likely, less likely, or very unlikely to find an HLA-matched unrelated donor, you will be assigned to one of 3 groups. These groups are as follows: Group 1 - Very likely to find an HLA-matched unrelated donor, Group 2 - Less likely to find an HLA-matched unrelated donor or Group 3 - Very unlikely to find an HLA-matched donor. Participants can expect to be in this study for up to 2 years after transplant.

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

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus-Host Disease in Subjects Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Date Added
July 1st, 2020
PRO Number
Pro00095489
Researcher
Michelle Hudspeth

List of Studies


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

This study is for patients that are getting an allogeneic hematopoietic stem cell transplantation (allo-HSCT) from an unrelated donor for a hematologic malignancy, (cancers that affect the blood and/or lymphatic system). The investigational drug in this study is Vedolizumab. This purpose of this study is to investigate the safety and effectiveness of Vedolizumab compared to placebo (dummy drug), for prevention of intestinal acute graft versus-host disease (aGvHD) in patients undergoing allo-HSCT. GvHD occurs when particular types of white blood cell (T cells) in the donated cells (the graft) attack patients own body cells.

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

A randomized trial of low versus moderate exposure busulfan for infants with severe combined immunodeficiency (SCID) receiving TCRαβ+/CD19+ depleted transplantation: A Phase II study by the Primary Immune Deficiency Treatment Consortium (PIDTC) and Pediatric Transplantation & Cellular Therapy Consortium (PTCTC) PIDTC "CSIDE" Protocol (Conditioning SCID Infants Diagnosed Early) PTCTC NMD 1801

Date Added
November 5th, 2019
PRO Number
Pro00091878
Researcher
Michelle Hudspeth

List of Studies


Keywords
Cancer, Infant, Pediatrics
Summary

This study is for children age 0-2 who have been diagnosed with severe combined immunodeficiency (SCID). In this study, participants will be randomized (select by chance) into groups that will decide the dose of chemotherapy they will receive, receive chemotherapy prior to a blood stem cell transplant, and have blood drawn for research tests. The purpose of this research study is to find out if lower doses of a chemotherapy drug called busulfan before stem cell transplant can help patients with SCID, and to see if the device the CliniMACS® is effective in preparing donor stem cells before the transplant. Participants can expect to be in this study for up to 3 years.

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

Randomized Controlled Trial of Olanzapine for the Control of Chemotherapy-induced Vomiting in Children Receiving Chemotherapy for Hematopoietic Stem Cell Transplant Conditioning

Date Added
November 5th, 2019
PRO Number
Pro00091874
Researcher
Michelle Hudspeth

List of Studies


Keywords
Cancer, Transplant
Summary

This study is for subjects that are about to receive high dose cyclophosphamide before a blood or bone marrow transplant (BMT). The investigational drug in this study is Olanzapine. This research is being done to find out whether adding olanzapine to standard medications will be helpful in controlling chemotherapy induced nausea in children. The total length of participation in this study will depend on how many days you are scheduled to receive chemotherapy, but can be up to a maximum of 2 weeks. We will review your chart for 100 days after transplant. There will be no extra visits to MUSC due to participating in the research study.

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

A phase II trial of tisagenlecleucel in first-line high-risk (HR) pediatric and young adult patients with B-cell acute ymphoblastic leukemia (B-ALL) who are minimal residual isease (MRD) positive at the end of consolidation (EOC) therapy

Date Added
October 22nd, 2019
PRO Number
Pro00092378
Researcher
Michelle Hudspeth

List of Studies


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

This study is for subjects that have been diagnosed with B-cell Acute Lymphoblastic Leukemia (B-ALL). The study treatment is called tisagenlecleucel (you may also see it referred to as CTL019, CART-19 or Kymriah™). The purpose of the study is to test an experimental approach called gene transfer in subjects that are considered to have high-risk Acute Lymphoblastic Leukemia (ALL), a type of blood cancer that involves cells in your blood called B cells.
Your study participation in this study will not last for more than 8 years. You will be asked to join another study after this trial so your study doctor can check on you for as long as 15 years after the treatment.

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

Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE Study)

Date Added
May 15th, 2019
PRO Number
Pro00081406
Researcher
Michelle Hudspeth

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with Epstein-Barr Virus associated Post-Transplant Lymphoproliferative Disorder (EBV-PTLD). The investigational drug in this study is tabelecleucel. Tabelecleucel is a product containing special immune allogeneic cells, called EBV-Cytotoxic T Lymphocytes (EBV-CTLs), that are made in the laboratory starting with cells from a healthy person who is immune to EBV. The purpose of this study is to test how well tabelecleucel works to treat EBV-PTLD following SOT in patients who have not responded to rituximab or rituximab plus chemotherapy treatment and to see what side effects happen. Your participation will help us to understand more about tabelecleucel. In the first 12-month period, participants will be asked to come to the clinic for an estimated 11 to 19 study visits and a minimum of 2 scans, depending on the number of cycles of treatment they are given. After treatment is done, participants will enter into the follow-up phase, and will continue to come into the clinic for scheduled check-ups for up to 24 months after the first dose of tabelecleucel was given. Participant information on the status of their disease and any new treatment will be collected for up to an additional 3 years. Participants can expect to be in this study for up to five years total.

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

Pathogen Identification in Pediatric Hematopoietic Stem Cell Transplant Patients with Suspected Lower Respiratory Tract Infection

Date Added
December 6th, 2016
PRO Number
Pro00060294
Researcher
Michelle Hudspeth

List of Studies


Keywords
Adolescents, Children's Health, Immune System, Lung, Pediatrics, Transplant
Summary

This study is for patient that have been diagnosed with suspected lower respiratory tract infection. The purpose of this study is to evaluate a new test that may be able to find more lung infections than current tests can. This new test is called next-generation sequencing and looks in respiratory secretions for bacteria, viruses, fungi, and other organisms that may cause infection. We hope to learn more about the usefulness of this new test in identifying infections.

Institution
MUSC
Recruitment Contact
Thomas Hortman
864-792-9579
hortman@musc.edu



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