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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 Michigan Ann Arbor, Michigan  48109-0624
Children's National Medical Center Washington, District of Columbia  20010-2970
Children's Hospital and Research Center at Oakland Oakland, California  94609-1809
Duke University Durham, North Carolina  27710
Vanderbilt University Nashville, Tennessee  37232-6305
Emory University Atlanta, Georgia  30322
Dana Farber Cancer Institute Boston, Massachusetts  02115
Washington University St. Louis, Missouri  63110
The University Of North Carolina At Chapel Hill Chapel Hill, North Carolina  27599-7235
Children's Memorial Hospital Chicago, Illinois  60614
University of Miami Miami, Florida  33136
Oregon Health and Science University Portland, Oregon  97201
Ut Southwestern Medical Center Dallas, Texas  75390
The Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Methodist Healthcare System of San Antonio San Antonio, Texas  78229
Regents of University of California- UCLA Los Angeles, California  90095
All Children's Research Institute, Inc. St. Petersburg, Florida  33701
The Research Institute at Nationwide Children's Hospital Columbus, Ohio  43205