Comparing the Effectiveness of Matched Related Donor Hematopoietic Stem Cell Transplantation to Disease Modifying Therapy in Pediatric Patients With Sickle Cell Disease.

Status: Recruiting
Location: See all (37) locations...
Study Type: Observational
SUMMARY

The WeDecide study is a large observational study comparing the long-term effects of matched related donor hematopoietic stem cell transplantation (MRD HCT) and non-transplant disease-modifying therapies (NT-DMT) for pediatric patients with sickle cell disease (SCD). The study aims to assess health-related quality of life (HRQoL), cognitive function, risks, and benefits of both treatments, including survival rates, chronic complications, and organ damage prevention. With 160 children in the MRD HCT group and 320 in the NT-DMT group, aged 3-20.9 years, the study will follow participants for three years, examining factors like disease severity, treatment history, and social determinants of health. By providing a comprehensive comparison, the study seeks to inform clinical decisions and improve understanding of SCD treatment outcomes, ultimately supporting families and healthcare providers in choosing the best treatment options.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 20
Healthy Volunteers: f
View:

• Pediatric patients aged between 3 and 20.9 years.

• Children diagnosed with sickle cell Anemia (HB SS or HBSB0 Thalassemia)

• For the MRD HCT group, children who are candidates for matched related donor hematopoietic stem cell transplantation (MRD HCT).

• For the NT-DMT group, children who are receiving non-transplant disease-modifying therapies (NT-DMT) for SCD.

• Participants (or their guardians) must provide informed consent to be part of the study.

• Participants must be willing to undergo the necessary assessments and follow-up visits over the 3-year study period.

Locations
United States
Alabama
Children's of Alabama (MRD-HCT)
RECRUITING
Birmingham
Children's of Alabama (NT-DMT)
NOT_YET_RECRUITING
Birmingham
Washington, D.c.
Children's National Hospital (MRD-HCT)
RECRUITING
Washington D.c.
Delaware
Nemours Children's Hospital, Delaware (MRD-HCT)
RECRUITING
Wilmington
Georgia
Children's Healthcare of Atlanta (MRD-HCT)
RECRUITING
Atlanta
Illinois
Comer Children's Hospital (MRD-HCT)
RECRUITING
Chicago
Indiana
Riley Children's Hospital (MRD-HCT)
RECRUITING
Indianapolis
Riley's Children Hospital (NT-DMT)
NOT_YET_RECRUITING
Indianapolis
Massachusetts
Boston Children's Hospital (MRD-HCT)
RECRUITING
Boston
Boston Children's Hospital (NT-DMT)
NOT_YET_RECRUITING
Boston
Missouri
Wahington Univ in St Louis (NT-DMT)
NOT_YET_RECRUITING
St Louis
Washington University in St Louis (MRD-HCT)
NOT_YET_RECRUITING
St Louis
North Carolina
UNC Children's Hospital (MRD HCT)
NOT_YET_RECRUITING
Chapel Hill
UNC Children's Hospital (NT-DMT)
NOT_YET_RECRUITING
Chapel Hill
Atrium Health (MRD-HCT)
RECRUITING
Charlotte
New Jersey
Hackensack University Hospital (MRD-HCT)
RECRUITING
Hackensack
New York
Roswell Park (MRD-HCT)
RECRUITING
Buffalo
Columbia Presbytarian (NT-DMT)
NOT_YET_RECRUITING
New York
Cohen's Children Hospital (NT-DMT)
NOT_YET_RECRUITING
Queens
University of Rochester (MRD-HCT)
NOT_YET_RECRUITING
Rochester
University of Rochester (NT-DMT)
NOT_YET_RECRUITING
Rochester
Children's Hospital at Montefiore (MRD HCT)
NOT_YET_RECRUITING
The Bronx
Children's Hospital at Montefiore (NT-DMT)
RECRUITING
The Bronx
Ohio
Nationwide Children's Hospital (NT-DMT)
NOT_YET_RECRUITING
Columbus
Oklahoma
Oklahoma Children's Hospital (MRD-HCT)
NOT_YET_RECRUITING
Oklahoma City
Pennsylvania
Children's Hospital of Philadelphia (MRD-HCT)
RECRUITING
Philadelphia
Tennessee
St Jude Children Hospital (NT-DMT)
NOT_YET_RECRUITING
Memphis
St. Jude Children's Research Hospital (MRD-HCT)
RECRUITING
Memphis
Texas
Texas Children's Hopsital (NT-DMT)
NOT_YET_RECRUITING
Houston
Texas Children's Hospital (MRD-HCT)
RECRUITING
Houston
UT San Antonio (NT-DMT)
NOT_YET_RECRUITING
San Antonio
Other Locations
Canada
Alberta Children's Hospital (MRD-HCT)
RECRUITING
Calgary
Alberta Children's Hospital (NT-DMT)
NOT_YET_RECRUITING
Calgary
Universite de Montreal / Ste Justine (MRD HCT)
NOT_YET_RECRUITING
Montreal
The Hospital for Sick Children (MRD-HCT)
NOT_YET_RECRUITING
Toronto
British Columbia Children's Hosptial (MRD HCT)
NOT_YET_RECRUITING
Vancouver
HSC Winnipeg Children's Hospital/University of Manitoba (MRD-HCT)
RECRUITING
Winnipeg
Contact Information
Primary
John Horan, MD, MPH
John_Horan@URMC.Rochester.edu
5852742345
Backup
Priya Kaushal, MPH
Priya_Kaushal@URMC.Rochester.edu
5852750932
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2030-10-01
Participants
Target number of participants: 480
Treatments
NT-DMT Cohort
This group includes 320 participants from U.S. and Canadian sites receiving non-transplant disease-modifying therapies, monitored annually over three years to assess health-related quality of life, cognitive function, disease progression, and healthcare utilization.
MRD HCT Cohort
This group includes 160 participants from U.S. and Canadian sites receiving non-transplant disease-modifying therapies, monitored annually over three years to assess health-related quality of life, cognitive function, disease progression, and healthcare utilization.
Sponsors
Leads: University of Rochester
Collaborators: Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov