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NCT00968162 · ClinicalTrials.gov registry record · Phase 1

Sickle Cell Disease Conditioning for Bone Marrow Transplant

A Phase 1 study, sponsored by Emory University.

Completed
Registry status
Phase 1
Development phase
8
Enrollment target

NCT00968162: Completed Phase 1 study, sponsored by Emory University.

NCT00968162 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00968162, a Phase 1 study, has completed, sponsored by Emory University.

COMPLETED
Registry status
Phase 1
Development phase
8 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG fludarabine

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2009-02
Est. Completion 2016-01-11
Phase Phase 1
Emory University

1,208 total trials

What the finished NCT00968162 record still lists

NCT00968162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 1 intervention - of which fludarabine is the first listed.

NCT00968162 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00968162 about?

NCT00968162 is a clinical study titled "Sickle Cell Disease Conditioning for Bone Marrow Transplant". 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, inclu...

What is the current status of trial NCT00968162?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2009-02. Estimated completion is 2016-01-11.

What interventions are being tested in trial NCT00968162?

The interventions under investigation include: fludarabine (DRUG).

Who is sponsoring clinical trial NCT00968162?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00968162's enrollment target sits among peer trials

8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00968162, the US trial registry maintained by the National Library of Medicine. NCT00968162 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.