The Impact of Human Papilloma Virus Vaccination in Pediatric Chronic Kidney Disease, Dialysis, and Transplant Patients + save

Date Added
June 4th, 2013
PRO Number
Pro00025387
Researcher
Katherine Twombley
Keywords
Kidney, Pediatrics, Transplant, Vaccine
Summary

The aim of the study is to determine the impact of the human papilloma virus (HPV) vaccination in Pediatric Chronic Kidney Disease, Dialysis, and Transplant Patients

Institution
MUSC
Recruitment Contact
Harvey Frampton
843-792-9454
frampton@musc.edu

The Role of Minimal Residual Disease Testing before and after Hematopoietic Cell Transplantation for Pediatric Acute Myeloid Leukemia + save

Date Added
June 4th, 2013
PRO Number
Pro00011017
Researcher
Michelle Hudspeth
Keywords
Adolescents, Cancer, Cancer/Leukemia, Children's Health, Infant, Pediatrics, Transplant
Summary

This study is being offerred to patients that have acute myelogenous leukemia (AML) which is a cancer of the blood and these patients are going to have a stem cell transplant. This study is looking to determine how accurate two different laboratory tests are at detecting residual, or small numbers of cancer cells in the body before and after stem cell transplant, as well as whether or not results of these two tests show how well a recipient might do after transplant.

Institution
MUSC
Recruitment Contact
Karen Rogers
843-792-2740
rogersk@musc.edu

A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients + save

Date Added
May 29th, 2013
PRO Number
Pro00017387
Researcher
Jennifer Jaroscak
Keywords
Cancer, Children's Health, Men's Health, Minorities, Pediatrics, Transplant, Women's Health
Summary

This study if for patients that have a blood disease and it's been determined that the best option for treating that blood disease is a cord blood transplant. Cord blood (CB) is blood that is taken from the umbilical cord and placenta of healthy newborn babies after childbirth. The cord blood collected from a newborn baby is called a cord blood unit. The United States Food and Drug Administration (FDA) considers cord blood to be a biological drug. These are considered “investigational” products. This study will evaluate the safety of administration of the investigational cord blood units by carefully documenting all infusion-related problems.

Institution
MUSC
Recruitment Contact
Jessica Simons
843-792-2708
simonsjl@musc.edu

Discovery and validation of genomic variants and proteomic biomarkers in a prospective observational tissue, blood and urine monitoring study of kidney transplant recipients + save

Date Added
March 19th, 2013
PRO Number
Pro00023348
Researcher
David Taber
Keywords
Transplant
Summary

This study will collect and analyze recipient blood and urine and donor tissue of adult kidney transplant recipients who are undergoing a renal transplant biopsy as part of their standard of care follow-up. The blood, urine, and tissue will be processed and analyzed for genomic variants and proteomic biomarkers that have been associated with immunosuppressant related adverse events and clinical outcomes, including graft dysfunction and graft loss. These patients will be followed clinically per the normal standard of care. The clinical outcomes of each patient are tracked using a transplant-specific clinical database (Velos and EPIC). The genomic polymorphisms and urinary proteomic biomarkers of each patient will be collected through blood, urine, and tissue samples and recorded and linked to the clinical outcomes data. Following this, the linked databases will be de-identified to PHI and analyzed to determine which genomic polymorphisms and/or proteomic biomarkers are most associated with deleterious clinical outcomes (graft dysfunction and graft loss).

Institution
MUSC
Recruitment Contact
David Taber
843-792-2724
taberd@musc.edu

PREVENTION OF CARDIAC ALLOGRAFT VASCULOPATHY USING RITUXIMAB (RITUXAN®) THERAPY IN CARDIAC TRANSPLANTATION + save

Date Added
March 19th, 2013
PRO Number
Pro00009464
Researcher
Adrian Van bakel
Keywords
Transplant
Summary

This is a prospective, multi-center, randomized, placebo-controlled clinical trial in which 400 primary heart
transplant recipients with a PRA of <10% will be randomized (1:1) to conventional immunosuppression
(tacrolimus, MMF and steroid taper) versus induction therapy with anti-CD20 mAb (1gm IV on day 0 and day 12
post-transplant) plus conventional immunosuppression (tacrolimus, MMF, and steroid taper).

Institution
MUSC
Recruitment Contact
Christina Creek
(843) 876-5008
russelcm@musc.edu

Cytogam administration in Abdominal Organ Transplant Recipients at High Risk for CMV infection + save

Date Added
February 12th, 2013
PRO Number
Pro00009601
Researcher
Kenneth Chavin
Keywords
Transplant
Summary

Up to 40 patients will be completing this study. This study will only be conducted at MUSC. All participants will be randomized, into two groups, one that takes Valganciclovir for 200 days after transplant and one that takes Valganciclovir for 100 days after transplant with Cytogam given at 90 days, 120 days, and 180 days post-transplant. The study will follow patients for 24 months after transplant.

Institution
MUSC
Recruitment Contact
Signe Hiser
843-792-8824
hiser@musc.edu

Phase 1/2A Study Carfilzomib + High Dose Melphalan as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation in Multiple Myeloma + save

Date Added
January 22nd, 2013
PRO Number
Pro00014849
Researcher
Luciano Costa
Keywords
Blood Disorders, Cancer, Transplant
Summary

The main purpose of this study in Phase I is to determine the maximum tolerated dose of carfilzomib when added to standard melphalan conditioning for AHSCT in relapsed Multiple Myeloma and in the Phase II portion of the study the purpose is to evaluate the anti-myeloma activity and the toxicity of carfilzomib + high dose melphalan conditioning in relapsed Multiple Myeloma

Institution
MUSC
Recruitment Contact
Jessica Simons
843-792-8856
simonsjl@musc.edu

A PHASE 3B MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED STUDY TO DEMONSTRATE THE SAFETY AND EFFICACY OF FIDAXOMICIN FOR PROPHYLAXIS AGAINST CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA IN ADULTS UNDERGOING HEMATOPOIETIC STEM CELL TRANSPLANTATION + save

Date Added
November 27th, 2012
PRO Number
Pro00020787
Researcher
Robert Stuart
Keywords
Cancer, Transplant
Summary

The purpose of this research study is to review the effectiveness and safety of fidaxomicin versus a placebo for the treatment of Clostridium difficile Associated Diarrhea (CDAD) in adults undergoing hematopoietic stem cell transplantation (HSCT).

Institution
MUSC
Recruitment Contact
Jessica Simons
843-792-8856
simonsjl@musc.edu

Incidence, risk factors, and outcomes associated with adverse drug reactions and medication errors within kidney transplantation + save

Date Added
November 16th, 2012
PRO Number
Pro00020011
Researcher
Justin Spivey
Keywords
Kidney, Transplant
Summary

This study is a retrospective chart review that will be conducted by the primary investigator aimed at determining the association between adverse drug reactions and medication errors with negative outcomes. These negative outcomes are defined as the occurrence of acute or chronic rejection. Data will be collected by chart review of patients meeting the inclusion and exclusion criteria between March 2009 and July 2011. Charts will be reviewed for information as outlined by the data monitoring form. Statistical analysis will be performed according to the appropriate statistical test. Estimated timeline following IRB approval is data collection from September through November and final manuscript draft and submission May.

Institution
MUSC
Recruitment Contact
David Taber
792-8532
taberd@musc.edu

A Phase 1/2 Study of CNDO-109-Activated Allogeneic Natural Killer Cells in Patients with High-Risk Acute Myeloid Leukemia in 1st Complete Remission (CR1) + save

Date Added
November 13th, 2012
PRO Number
Pro00016987
Researcher
Robert Stuart
Keywords
Cancer, Drug Studies, Men's Health, Transplant, Women's Health
Summary

The main purpose of this study is to evaluate CNDO-109 Activated Allogeneic Natural Killer Cells (NK Cells) and how participants with Acute Myeloid Leukemia (AML) respond when given this therapy. The primary objective of this study is to define the maximum tolerated dose (MTD), or the maximum tested dose of CNDO-109-Activated Allogeneic Natural Killer cells infused (given) after preparative chemotherapy. NK cells are a type of blood cell in your immune system that attack cancer cells.

Institution
MUSC
Recruitment Contact
Jessica Simons
846-792-8856
simonsj@musc.edu