Actively Recruiting

Age: 3Years - 20Years
All Genders
NCT06941389

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

Led by University of Rochester · Updated on 2025-06-19

480

Participants Needed

37

Research Sites

330 weeks

Total Duration

On this page

Sponsors

U

University of Rochester

Lead Sponsor

P

Patient-Centered Outcomes Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 3Years - 20Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pediatric patients aged between 3 and 20.9 years
  • Children diagnosed with sickle cell anemia (HB SS or HBSB0 Thalassemia)
  • Children who are candidates for matched related donor hematopoietic stem cell transplantation (MRD HCT) for the MRD HCT group
  • Children receiving non-transplant disease-modifying therapies (NT-DMT) for SCD for the NT-DMT group
  • Participants or their guardians must provide informed consent
  • Participants must be willing to undergo assessments and follow-up visits over 3 years
Not Eligible

You will not qualify if you...

  • Children younger than 3 years or older than 20.9 years
  • Children without sickle cell anemia or related conditions
  • Children not eligible for MRD HCT or without a matched related donor in the MRD HCT group
  • Children currently enrolled in other clinical trials that may interfere with this study
  • Children unable to follow the study protocol or complete required follow-up

AI-Screening

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Trial Site Locations

Total: 37 locations

1

Children's of Alabama (MRD-HCT)

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

Children's of Alabama (NT-DMT)

Birmingham, Alabama, United States, 35294

Not Yet Recruiting

3

Nemours Children's Hospital, Delaware (MRD-HCT)

Wilmington, Delaware, United States, 19803

Actively Recruiting

4

Children's National Hospital (MRD-HCT)

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

5

Children's Healthcare of Atlanta (MRD-HCT)

Atlanta, Georgia, United States, 30329

Actively Recruiting

6

Comer Children's Hospital (MRD-HCT)

Chicago, Illinois, United States, 60637

Actively Recruiting

7

Riley Children's Hospital (MRD-HCT)

Indianapolis, Indiana, United States, 46202

Actively Recruiting

8

Riley's Children Hospital (NT-DMT)

Indianapolis, Indiana, United States, 46202

Not Yet Recruiting

9

Boston Children's Hospital (MRD-HCT)

Boston, Massachusetts, United States, 02115

Actively Recruiting

10

Boston Children's Hospital (NT-DMT)

Boston, Massachusetts, United States, 02115

Not Yet Recruiting

11

Wahington Univ in St Louis (NT-DMT)

St Louis, Missouri, United States, 63130

Not Yet Recruiting

12

Washington University in St Louis (MRD-HCT)

St Louis, Missouri, United States, 63130

Not Yet Recruiting

13

Hackensack University Hospital (MRD-HCT)

Hackensack, New Jersey, United States, 07601

Actively Recruiting

14

Roswell Park (MRD-HCT)

Buffalo, New York, United States, 14203

Actively Recruiting

15

Columbia Presbytarian (NT-DMT)

New York, New York, United States, 10032

Not Yet Recruiting

16

Cohen's Children Hospital (NT-DMT)

Queens, New York, United States, 11040

Not Yet Recruiting

17

University of Rochester (MRD-HCT)

Rochester, New York, United States, 14642

Not Yet Recruiting

18

University of Rochester (NT-DMT)

Rochester, New York, United States, 14642

Not Yet Recruiting

19

Children's Hospital at Montefiore (MRD HCT)

The Bronx, New York, United States, 10467

Not Yet Recruiting

20

Children's Hospital at Montefiore (NT-DMT)

The Bronx, New York, United States, 10467

Actively Recruiting

21

UNC Children's Hospital (MRD HCT)

Chapel Hill, North Carolina, United States, 27514

Not Yet Recruiting

22

UNC Children's Hospital (NT-DMT)

Chapel Hill, North Carolina, United States, 27599.

Not Yet Recruiting

23

Atrium Health (MRD-HCT)

Charlotte, North Carolina, United States, 28203

Actively Recruiting

24

Nationwide Children's Hospital (NT-DMT)

Columbus, Ohio, United States, 43205

Not Yet Recruiting

25

Oklahoma Children's Hospital (MRD-HCT)

Oklahoma City, Oklahoma, United States, 73104

Not Yet Recruiting

26

Children's Hospital of Philadelphia (MRD-HCT)

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

27

St Jude Children Hospital (NT-DMT)

Memphis, Tennessee, United States, 38105

Not Yet Recruiting

28

St. Jude Children's Research Hospital (MRD-HCT)

Memphis, Tennessee, United States, 38105

Actively Recruiting

29

Texas Children's Hopsital (NT-DMT)

Houston, Texas, United States, 77030

Not Yet Recruiting

30

Texas Children's Hospital (MRD-HCT)

Houston, Texas, United States, 77030

Actively Recruiting

31

UT San Antonio (NT-DMT)

San Antonio, Texas, United States, 78229

Not Yet Recruiting

32

Alberta Children's Hospital (NT-DMT)

Calgary, Alberta, Canada, T3B 6A8

Not Yet Recruiting

33

Alberta Children's Hospital (MRD-HCT)

Calgary, Alberta, Canada, T3B6A8

Actively Recruiting

34

British Columbia Children's Hosptial (MRD HCT)

Vancouver, British Columbia, Canada

Not Yet Recruiting

35

HSC Winnipeg Children's Hospital/University of Manitoba (MRD-HCT)

Winnipeg, Manitoba, Canada, R3E 0V9

Actively Recruiting

36

The Hospital for Sick Children (MRD-HCT)

Toronto, Ontario, Canada, ON M5G 1E8

Not Yet Recruiting

37

Universite de Montreal / Ste Justine (MRD HCT)

Montreal, Quebec, Canada

Not Yet Recruiting

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Research Team

J

John Horan, MD, MPH

CONTACT

P

Priya Kaushal, MPH

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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