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


Phase 2
1 Year
16 Years
Open (Enrolling)
Both
Severe Thalassemia

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary objective: To determine event-free survival at 1 year.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Shalini Shenoy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University Medical Center

Authority:

United States: Institutional Review Board

Study ID:

TCRN-NMD 0901

NCT ID:

NCT01005576

Start Date:

January 2010

Completion Date:

Related Keywords:

  • Severe Thalassemia
  • Thalassemia
  • Alemtuzumab
  • Hematopoietic cell transplant
  • non-myeloablative
  • Thalassemia

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Hospital and Research Center at OaklandOakland, California  94609-1809
Duke UniversityDurham, North Carolina  27710
Vanderbilt UniversityNashville, Tennessee  37232-6305
Emory UniversityAtlanta, Georgia  30322
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Washington UniversitySt. Louis, Missouri  63110
The University Of North Carolina At Chapel HillChapel Hill, North Carolina  27599-7235
Children's Memorial HospitalChicago, Illinois  60614
University of MiamiMiami, Florida  33136
Oregon Health and Science UniversityPortland, Oregon  97201
Ut Southwestern Medical CenterDallas, Texas  75390
The Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Methodist Healthcare System of San AntonioSan Antonio, Texas  78229
Regents of University of California- UCLALos Angeles, California  90095
All Children's Research Institute, Inc.St. Petersburg, Florida  33701
The Research Institute at Nationwide Children's HospitalColumbus, Ohio  43205