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NCT00408447 · ClinicalTrials.gov registry record · Phase 2

Stem Cell Transplant in Sickle Cell Disease and Thalassemia

A Phase 2 study of Sickle Cell Disease and Beta-Thalassemia, sponsored by Columbia University.

Active
Registry status
Phase 2
Development phase
53
Enrollment target
1
Study location

NCT00408447 is a Phase 2 study of Sickle Cell Disease and Beta-Thalassemia that is active but no longer recruiting, run by Columbia University. The registered enrollment target is 53 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00408447, a Phase 2 study of Sickle Cell Disease and Beta-Thalassemia, is active but no longer recruiting, sponsored by Columbia University.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
53 participants
Enrollment target
1
Study location

Study Summary

The primary purpose of this study is to see if giving lower doses of chemotherapy (moderately ablative) will result in successful bone marrow replacement without as severe side-effects but with permanent control of the disease. Patients will receive a chemotherapy regimen with busulfan, fludarabine, and alemtuzumab followed by an infusion of stem cells, either from a family-related or cord-blood matched donor.

Interventions

  • DRUG Fludarabine
  • DRUG Busulfan
  • DRUG Alemtuzumab
  • PROCEDURE Allogeneic stem cell transplant

Study Locations (1)

New York

  • Morgan Stanley Children's Hospital, New York-Presbyterian, Columbia University - New York

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2004-09
Est. Completion 2025-02
Phase Phase 2

Sponsor

Columbia University

958 total trials

What the Registry Record Tells You About NCT00408447

The ClinicalTrials.gov registry entry for NCT00408447 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (82% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 4 interventions - of which Fludarabine is the first listed.

NCT00408447 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT00408447 about?

NCT00408447 is a clinical study titled "Stem Cell Transplant in Sickle Cell Disease and Thalassemia". The primary purpose of this study is to see if giving lower doses of chemotherapy (moderately ablative) will result in successful bone marrow replacement without as severe side-effects but with permanent control of the disease. Patients will receive a chemotherapy regimen with busulfan, fludarabine,...

What is the current status of trial NCT00408447?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2004-09. Estimated completion is 2025-02.

What conditions does trial NCT00408447 study?

This clinical trial studies the following conditions: Sickle Cell Disease, Beta-Thalassemia.

What interventions are being tested in trial NCT00408447?

The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), Alemtuzumab (DRUG), Allogeneic stem cell transplant (PROCEDURE).

Who is sponsoring clinical trial NCT00408447?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00408447 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.