Reduced Intensity Transplant Conditioning Regimen for Severe Thalassemia



Status:Completed
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:1 - 16
Updated:12/15/2017
Start Date:January 2010
End Date:July 2014

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria

A Pilot Trial of Unrelated Donor Hematopoietic Cell Transplantation for Children With Severe Thalassemia Using a Reduced Intensity Conditioning Regimen (The URTH Trial)

This study is being done to determine if blood cell transplants, with either bone marrow or
cord blood from unrelated donors, are effective in children with severe thalassemia and if
this treatment approach has acceptable risks and side effects.

This study includes a preparative regimen with Hydroxyurea, Alemtuzumab, Fludarabine,
Thiotepa and Melphalan that provides intense host immunosuppression without myeloablation.
The primary hypothesis is that this regimen will promote stable engraftment of unrelated
donor hematopoietic cells, support normal erythropoiesis, and result in an event free
survival of > 75% of children with thalassemia major.


Inclusion Criteria:

- 1-16.00 years old

- Have transfusion dependent thalassemia major

- Shall not have an HLA-matched family donor

- Must have a suitably matched unrelated marrow donor or UCB product

- Lansky score >/= 70

- Adequate pulmonary, renal, liver, and other organ function as defined in protocol

- Negative pregnancy test

- Adequate total nucleated cell or CD34+ dose of product as defined in protocol

- Iron chelation must be discontinued >/= 48 hours prior to conditioning regimen

Exclusion Criteria:

- Pregnant or breastfeeding

- HIV positive

- Prior allogeneic marrow or stem cell transplantation
We found this trial at
18
sites
Regents of University of California- UCLA
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Emory University
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Duke University
Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
?
mi
from
Durham, NC
Click here to add this to my saved trials
University of Miami
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
?
mi
from
Miami, FL
Click here to add this to my saved trials
Children's Hospital and Research Center Oakland
747 52nd St
Oakland, California 94609
(510) 428-3000
Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
?
mi
from
Oakland, CA
Click here to add this to my saved trials
Children's Hospital of Philadelphia
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Oregon Health and Science University
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
?
mi
from
Portland, OR
Click here to add this to my saved trials
University of Michigan
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Dana-Farber Cancer Institute
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Children's Memorial Hospital
Chicago, Illinois 60614
?
mi
from
Chicago, IL
Click here to add this to my saved trials
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio 43205
?
mi
from
Columbus, OH
Click here to add this to my saved trials
U.T. Southwestern Medical Center
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Vanderbilt University
2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Washington University
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
All Children's Research Institute
Saint Petersburg, Florida 33701
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
Methodist Healthcare System of San Antonio
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Childrens National Medical Center
111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
?
mi
from
Washington,
Click here to add this to my saved trials