Reduced Intensity Transplant Conditioning Regimen for Severe Thalassemia
Public ClinicalTrials.gov record NCT01005576. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Pilot Trial of Unrelated Donor Hematopoietic Cell Transplantation for Children With Severe Thalassemia Using a Reduced Intensity Conditioning Regimen (The URTH Trial)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01005576
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 21 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Year to 16 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2010 (Type not available)
- Primary completion
- Apr 2014 (Actual)
- Completion
- Jul 2014 (Actual)
- Last update posted
- Dec 13, 2017
2010 – 2014
United States locations
- U.S. sites
- 18
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Regents of University of California- UCLA | Los Angeles | California | 90095 | — |
| Children's Hospital and Research Center at Oakland | Oakland | California | 94609 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| University of Miami | Miami | Florida | 33136 | — |
| All Children's Research Institute, Inc. | St. Petersburg | Florida | 33701 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Children's Memorial Hospital | Chicago | Illinois | 60614 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| The Research Institute at Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Vanderbilt University | Nashville | Tennessee | 37232 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Methodist Healthcare System of San Antonio | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01005576, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 13, 2017 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01005576 live on ClinicalTrials.gov.