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) Save

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

List of Studies


Profiles_link
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

Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab (MATCH Study) Save

Date Added
May 8th, 2019
PRO Number
Pro00081745
Researcher
Michelle Hudspeth

List of Studies


Profiles_link
Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with EBV-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. Tabelecleucel will be given by vein as an injection. The purpose of this study is to test how well ATA129 works to treat EBV-PTLD following failure of rituximab in patients who have had an alloHCT and to see what side effects happen. Participation will help us to understand more about ATA129. 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

eACT (epilepsy: Adherence in children and technology) Save

Date Added
May 4th, 2019
PRO Number
Pro00087259
Researcher
Janelle Wagner

List of Studies

Silhouette
Keywords
Children's Health, Epilepsy, Pediatrics
Summary

The aim of this multi-site study is to evaluate the effectiveness of mHealth intervention strategies for improving anti-epileptic drug adherence in caregivers of young children with epilepsy. A 2-month baseline period will be followed by two stages. In Stage 1 (3-months), caregivers will received either 1) a mHealth education module and automated digital reminders or 2) the mHealth education module, automated digital reminders, and individualized adherence feedback based. In Stage 2 (2-months), caregivers will either receive 1) continued individualized adherence feedback or 2) individualized adherence feedback and a mHealth problem-solving module. The primary outcome is electronically-monitored adherence. Secondary outcomes include seizure severity/frequency, quality of life and healthcare utilization.

Institution
MUSC
Recruitment Contact
Millie Griffin
843-792-4653
grifm@musc.edu

A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Axitinib or Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups Save

Date Added
April 29th, 2019
PRO Number
Pro00088789
Researcher
Jacqueline Kraveka

List of Studies


Profiles_link
Keywords
Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed kidney cancer called TFE/Translocation Renal Cell Carcinoma (tRCC). The investigational drugs in this study are axitinib and nivolumab. Both axitinib and nivolumab have been approved by the FDA for treating RCC. However, using these 2 drugs together is considered experimental. The purpose of this study is to find out what effects, good and/or bad, axitinib and nivolumab have on subjects with tRCC when the drugs are given alone or in combination. Participants can expect to be on this study for about to years and followed for up to 5 years.

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

Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial Save

Date Added
March 26th, 2019
PRO Number
Pro00087159
Researcher
Jacqueline Kraveka

List of Studies


Profiles_link
Keywords
Cancer, Heart, Pediatrics
Summary

This study is for patients that are survivors of childhood cancer who received a type of treatment called anthracycline chemotherapy at a young age. The investigational drug in this study is carvedilol. Medications such as carvedilol have been shown to improve heart function and delay the onset of heart failure. However, carvedilol has not been studied in a large group of childhood cancer survivors who received anthracycline chemotherapy. The purpose of this study is to see if a two-year course of carvedilol in childhood cancer survivors to see if it will have the same effects as shown in these prior studies of people with mild heart failure or who were at risk for heart failure. People in this clinical trial are expected to receive treatment on this study for about 2 years.

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

SMYLS: A Self-Management Program for Youth Living with Sickle Cell Disease Save

Date Added
March 17th, 2019
PRO Number
Pro00084400
Researcher
Shannon Hudson

List of Studies


Profiles_link
Keywords
Adolescents, Blood Disorders, Pain, Pediatrics
Summary

The purpose of this study is to find out whether a web-based intervention using a mobile device is helpful for teens learning to care for and manage symptoms of their sickle cell disease. The intervention lasts 12 weeks with a 3-month follow up period, and uses a smartphone or a tablet. For more information, please contact Shannon at 843-792-9379.

Institution
MUSC
Recruitment Contact
Shannon Phillips
843-792-9379
phillipss@musc.edu

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Assess the Efficacy and Safety of Apremilast (CC 10004) in Pediatric Subjects from 6 through 17 Years with Moderate to Severe Plaque Psoriasis Save

Date Added
January 22nd, 2019
PRO Number
Pro00084118
Researcher
Lara Wine lee

List of Studies

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Keywords
Drug Studies, Pediatrics, Skin
Summary

The purpose of this study is to test and compare the effects of an investigational (being tested) drug called apremilast to placebo in pediatric plaque psoriasis.
Participants who are determined to be eligible to participate will be assigned by chance (or randomized) to treatment with apermilast or placebo. At Week 16, participants will receive apremilast regardless of treatment group. Study and safety assessments, including questionnaires and blood draws, will be completed at study visits. The maximum amount of time participants will be in the study is 71 weeks (at least 19 visits).

Institution
MUSC
Recruitment Contact
Reshil-Marie Dukes
843-792-0387
dukesre@musc.edu

A PROSPECTIVE, MULTICENTER OBSERVATIONAL STUDY TO EVALUATE THYROID FUNCTION OF PEDIATRIC SUBJECTS FROM BIRTH TO 3 YEARS EXPOSED TO ISOVUE® (IOPAMIDOL INJECTION) Save

Date Added
January 18th, 2019
PRO Number
Pro00084894
Researcher
Uwe o.p. Schoepf

List of Studies


Profiles_link
Keywords
Pediatrics
Summary

This study aims to collect data to determine if pediatric subjects up to 3 years of age develop abnormal thyroid function after exposure to iodinated contrast agents. This study will investigate subject thyroid function before and after administration of ISOVUE through pre-dose, 1 and 2 month post-dose follow-ups including TSH, T3, and T4 lab-work, and 6 and 12 month follow ups of a questionnaire.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
8437921213
choudhar@musc.edu

Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy Save

Date Added
January 9th, 2019
PRO Number
Pro00084750
Researcher
Jacqueline Kraveka

List of Studies


Profiles_link
Keywords
Cancer/Leukemia, Cancer/Lymphoma, Pediatrics
Summary

This study is for patients that have been diagnosed with Leukemia or Lymphoma. and have been treated on one of the following studies: Pediatric Oncology Group (POG) 9404, 9425, 9426, or Dana Farber Cancer Institute (DFCI) ALL Consortium 95-01. The purpose of this study is to look at the heart function of patients selected by change to get DRZ compared to the heart function of patients selected by chance not to get DRZ. In this study, they will also look at gender, age at cancer diagnosis, current age, dose of chemotherapy, and if chest radiation influences the risk of early heard damage. Participants in this clinical trial are expected to come to one clinic visit.

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

A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients Save

Date Added
January 7th, 2019
PRO Number
Pro00083234
Researcher
Jacqueline Kraveka

List of Studies


Profiles_link
Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with a pediatric brain tumor called medulloblastoma. The purpose of this study is to find out if a reduced dose of radiation to the whole brain and spine and less chemotherapy can be given to children and young adults with WNT subtype medulloblastoma without increasing the risk of the tumor coming back. Participants can expect to be in this study for about one year, and then followed for up to 10 years.

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

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