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NCT00176852 · ClinicalTrials.gov registry record · Phase 2

Stem Cell Transplant for Hemoglobinopathy

A Phase 2 study of Sickle Cell Disease and Thalassemia, sponsored by Masonic Cancer Center, University of Minnesota.

Completed
Registry status
Phase 2
Development phase
22
Enrollment target
1
Study location

NCT00176852 is a Phase 2 study of Sickle Cell Disease and Thalassemia that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 22 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00176852, a Phase 2 study of Sickle Cell Disease and Thalassemia, has completed, sponsored by Masonic Cancer Center, University of Minnesota.

COMPLETED
Registry status
Phase 2
Development phase
22 participants
Enrollment target
1
Study location

Study Summary

This study tests the clinical outcomes of one of two preparative regimens (determined by available donor source) in patients with non-malignant hemoglobinopathies. The researchers hypothesize that these regimens will have a positive effect on post transplant engraftment and the incidence of graft-versus-host-disease. Regimen A2 has replaced Regimen A in this study. Two patients were treated on Regimen A but did not have evidence of initial engraftment thus triggering the stopping rule for that arm of this study.

Interventions

  • RADIATION Total Body Irradiation
  • PROCEDURE Stem cell infusion
  • DRUG Busulfan, Fludarabine, ATG, TLI
  • DRUG Busulfan, Cyclophosphamide, ATG, GCSF
  • DRUG Campath, Fludarabine, Cyclophosphamide

Study Locations (1)

Minnesota

  • Masonic Cancer Center, University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2002-06
Est. Completion 2020-01
Phase Phase 2

What the Registry Record Tells You About NCT00176852

The ClinicalTrials.gov registry entry for NCT00176852 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 22 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 (92% lower). The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 5 interventions - of which Total Body Irradiation is the first listed.

NCT00176852 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT00176852 about?

NCT00176852 is a clinical study titled "Stem Cell Transplant for Hemoglobinopathy". This study tests the clinical outcomes of one of two preparative regimens (determined by available donor source) in patients with non-malignant hemoglobinopathies. The researchers hypothesize that these regimens will have a positive effect on post transplant engraftment and the incidence of graft-ve...

What is the current status of trial NCT00176852?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2002-06. Estimated completion is 2020-01.

What conditions does trial NCT00176852 study?

This clinical trial studies the following conditions: Sickle Cell Disease, Thalassemia, Diamond-Blackfan Anemia, Shwachman-Diamond Syndrome, Severe Congenital Neutropenia.

What interventions are being tested in trial NCT00176852?

The interventions under investigation include: Total Body Irradiation (RADIATION), Stem cell infusion (PROCEDURE), Busulfan, Fludarabine, ATG, TLI (DRUG), Busulfan, Cyclophosphamide, ATG, GCSF (DRUG), Campath, Fludarabine, Cyclophosphamide (DRUG).

Who is sponsoring clinical trial NCT00176852?

This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00176852 being conducted?

This trial has 1 study location across Minnesota. 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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