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Completed Phase 1 Interventional

Sickle Cell Disease Conditioning for Bone Marrow Transplant

ClinicalTrials.gov ID: NCT00968162

Public ClinicalTrials.gov record NCT00968162. 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.

ClinicalTrials.gov public records Last synced Sep 24, 2026, 4:10 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Toward a Less Toxic Yet Highly Effective Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Children and Adolescents With Severe Sickle Cell Disease: A Pilot Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Most bone marrow transplants for children with sickle cell disease are performed using high doses of two chemotherapy agents: busulfan and cyclophosphamide for the pre-transplant conditioning. This approach produces cure in most cases (approximately 95%). It, however, has serious side effects, including seizures and infertility. The primary goal of this study is to determine how much we can lower the dosages of busulfan and cyclophosphamide by incorporating fludarabine, a safer chemotherapy agent, into conditioning. The secondary goal is to develop a better understanding of how bone marrow transplants cause neurologic problems like seizures.

Study identification

NCT ID
NCT00968162
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Emory University
Other
Enrollment
8 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Up to 18 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 31, 2009
Primary completion
Feb 28, 2014
Completion
Jan 10, 2016
Last update posted
Jul 24, 2017

2009 – 2016

United States locations

U.S. sites
10
U.S. states
10
U.S. cities
10
Facility City State ZIP Site status
University of Alabama-Birmingham Birmingham Alabama — —
Children's National Medical Center Washington D.C. District of Columbia — —
All Children's Research Institute Inc. St. Petersburg Florida 33701 —
Children's Healthcare of Atlanta Atlanta Georgia 30322 —
Tulane University New Orleans Louisiana 70112 —
Wayne State University Detroit Michigan 48202 —
University of Mississippi Medical Center Jackson Mississippi — —
Montefiore Medical Center The Bronx New York — —
University of North Carolina at Chapel Hill Chapel Hill North Carolina 27516 —
University of Texas Southwestern Dallas Texas — —

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 NCT00968162, 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 Jul 24, 2017 · Synced Sep 24, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00968162 live on ClinicalTrials.gov.

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