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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 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 8 participants.

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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

Sponsor

Emory University

1,208 total trials

What the Registry Record Tells You About NCT00968162

The ClinicalTrials.gov registry entry for NCT00968162 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

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

NCT00968162 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.