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COMPLETED Phase 2

Allogeneic Stem Cell Transplantation Following Chemotherapy in Patients With Hemoglobinopathies

NCT00153985 · View on ClinicalTrials.gov ↗

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

819 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00153985

The ClinicalTrials.gov registry entry for NCT00153985 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 819 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00153985 reports 6 study locations spanning 4 distinct geographic areas — top geographies include Massachusetts, Georgia, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00153985?

The interventions under investigation include: Fludarabine (DRUG), Alemtuzumab (DRUG), Busulfex (DRUG), Stem Cell Transfusion (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00153985?

This trial is sponsored by Dana-Farber Cancer Institute, which has 819 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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