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NCT00010335 · ClinicalTrials.gov registry record · Phase 1

Pilot Study of Total Body Irradiation in Combination With Cyclophosphamide, Anti-thymocyte Globulin, and Autologous CD34-Selected Peripheral Blood Stem Cell Transplantation in Children With Refractory Autoimmune Disorders

A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.

Completed
Registry status
Phase 1
Development phase
6
Enrollment target

NCT00010335: Completed Phase 1 study, sponsored by Fred Hutchinson Cancer Center.

NCT00010335 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00010335, a Phase 1 study, has completed, sponsored by Fred Hutchinson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
6 participants
Enrollment target

Study Summary

OBJECTIVES: I. Determine the safety and long term complications of total body irradiation in combination with cyclophosphamide, anti-thymocyte globulin, and autologous CD34-selected peripheral blood stem cell (PBSC) transplantation in children with refractory autoimmune disorders. II. Determine the efficacy of this treatment regimen in these patients. III. Determine the reconstitution of immunity after autologous CD34-selected PBSC transplantation in these patients. IV. Determine engraftment of autologous CD34-selected PBSC in these patients.

Interventions

  • PROCEDURE Stem Cell Transplantation
  • DEVICE CD34 selection

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2000-11
Est. Completion 2011-05
Phase Phase 1
Fred Hutchinson Cancer Center

483 total trials

What the finished NCT00010335 record still lists

NCT00010335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 2 interventions - of which Stem Cell Transplantation is the first listed.

NCT00010335 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00010335 about?

NCT00010335 is a clinical study titled "Pilot Study of Total Body Irradiation in Combination With Cyclophosphamide, Anti-thymocyte Globulin, and Autologous CD34-Selected Peripheral Blood Stem Cell Transplantation in Children With Refractory Autoimmune Disorders". OBJECTIVES: I. Determine the safety and long term complications of total body irradiation in combination with cyclophosphamide, anti-thymocyte globulin, and autologous CD34-selected peripheral blood stem cell (PBSC) transplantation in children with refractory autoimmune disorders. II. Determine the...

What is the current status of trial NCT00010335?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2000-11. Estimated completion is 2011-05.

What interventions are being tested in trial NCT00010335?

The interventions under investigation include: Stem Cell Transplantation (PROCEDURE), CD34 selection (DEVICE).

Who is sponsoring clinical trial NCT00010335?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00010335's enrollment target sits among peer trials

6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00010335, the US trial registry maintained by the National Library of Medicine. NCT00010335 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.