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NCT00153985 · ClinicalTrials.gov registry record · Phase 2

Allogeneic Stem Cell Transplantation Following Chemotherapy in Patients With Hemoglobinopathies

A Phase 2 study of Sickle Cell Disease and Thalassemia, sponsored by Dana-Farber Cancer Institute.

Completed
Registry status
Phase 2
Development phase
2
Enrollment target
6
Study locations

NCT00153985 is a Phase 2 study of Sickle Cell Disease and Thalassemia that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 2 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (99% lower). The trial reports 6 study locations across 4 states.

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The verdict

NCT00153985, a Phase 2 study of Sickle Cell Disease and Thalassemia, has completed, sponsored by Dana-Farber Cancer Institute.

COMPLETED
Registry status
Phase 2
Development phase
2 participants
Enrollment target
6
Study locations

Study Summary

The purpose of this study is to determine if treatment with reduced-dose busulfex, fludarabine and alemtuzumab (CAMPATH) followed by sten cell infusion will allow for donor stem cells to grow in patients with hemoglobinopathies bone marrow and restore circulating blood counts. In addition the incidence and severity of side effects and of graft vs. host disease (GVHD) will be monitored.

Interventions

  • DRUG Fludarabine
  • DRUG Alemtuzumab
  • DRUG Busulfex
  • PROCEDURE Stem Cell Transfusion

Study Locations (6)

Massachusetts

  • Beth Israel Deaconess Medical Center - Boston
  • Dana-Farber Cancer Institute - Boston
  • Massachusetts General Hospital - Boston

Georgia

  • Winship Cancer Institute-Emory University - Atlanta

Louisiana

  • Feist-Weiller Cancer Center-LSU - Shreveport

Ohio

  • Ohio State University College of Medicine - Columbus

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2004-03
Est. Completion 2009-07
Phase Phase 2

Sponsor

Dana-Farber Cancer Institute

781 total trials

What the Registry Record Tells You About NCT00153985

The ClinicalTrials.gov registry entry for NCT00153985 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 2 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 (99% lower). The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 4 interventions - of which Fludarabine is the first listed.

NCT00153985 reports 6 study locations spanning 4 distinct geographic areas - top geographies include Massachusetts, Georgia, Louisiana.

Frequently Asked Questions

What is clinical trial NCT00153985 about?

NCT00153985 is a clinical study titled "Allogeneic Stem Cell Transplantation Following Chemotherapy in Patients With Hemoglobinopathies". The purpose of this study is to determine if treatment with reduced-dose busulfex, fludarabine and alemtuzumab (CAMPATH) followed by sten cell infusion will allow for donor stem cells to grow in patients with hemoglobinopathies bone marrow and restore circulating blood counts. In addition the incide...

What is the current status of trial NCT00153985?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2004-03. Estimated completion is 2009-07.

What conditions does trial NCT00153985 study?

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

What interventions are being tested in trial NCT00153985?

The interventions under investigation include: Fludarabine (DRUG), Alemtuzumab (DRUG), Busulfex (DRUG), Stem Cell Transfusion (PROCEDURE).

Who is sponsoring clinical trial NCT00153985?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00153985 being conducted?

This trial has 6 study locations across Georgia, Louisiana, Massachusetts, Ohio. 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

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