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NCT00716066 · ClinicalTrials.gov registry record · Phase 2

Autologous Stem Cell Transplant for Neurologic Autoimmune Diseases

A Phase 2 study of Autoimmune Disease and Stiff Person Syndrome, sponsored by Fred Hutchinson Cancer Center.

Active
Registry status
Phase 2
Development phase
53
Enrollment target
3
Study locations

NCT00716066: Active Phase 2 study of Autoimmune Disease and Stiff Person Syndrome, sponsored by Fred Hutchinson Cancer Center.

NCT00716066 is a Phase 2 study of Autoimmune Disease and Stiff Person Syndrome that is active but no longer recruiting, run by Fred Hutchinson Cancer Center. The registered enrollment target is 53 participants, below the 1,506-participant average among 10 other Autoimmune Disease trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00716066, a Phase 2 study of Autoimmune Disease and Stiff Person Syndrome, is active but no longer recruiting, sponsored by Fred Hutchinson Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
53 participants
Enrollment target
3
Study locations

Study Summary

This phase II trial studies the side effects and how well carmustine, etoposide, cytarabine and melphalan together with antithymocyte globulin before a stem cell transplant works in treating patients with autoimmune neurologic disease that did not respond to previous therapy. In autoimmune neurological diseases, the patient's own immune system 'attacks' the nervous system which might include the brain/spinal cord and/or the peripheral nerves. Giving high-dose chemotherapy, including carmustine, etoposide, cytarabine, melphalan, and antithymocyte globulin, before a stem cell transplant weakens the immune system and may help stop the immune system from 'attacking' a patient's nervous system. When the patient's own (autologous) stem cells are infused into the patient they help the bone marrow make red blood cells, white blood cells, and platelets so the blood counts can improve.

Primary Outcome

Assessed by the Regimen Related Toxicity Scale. Using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. The development of a grade 4 to 5 toxicity of any of the included major organ systems within the first 365 days after transplant will be defined as regimen-related toxicity.

Conditions Studied

Autoimmune Disease Stiff Person Syndrome Neurologic Autoimmune Disease Autologous Transplant Autoimmune Multiple Sclerosis Transplant MS Stem Cell Transplant Multiple Sclerosis Stem Cell Transplant HCT for Neurologic Autoimmune Disorders CIDP Transplant Myasthenia Gravis Transplant

Interventions

  • DRUG Etoposide
  • BIOLOGICAL Anti-Thymocyte Globulin
  • DRUG Cytarabine
  • DRUG Carmustine
  • PROCEDURE Autologous Hematopoietic Stem Cell Transplantation

Study Locations (3)

Washington

  • Fred Hutch/University of Washington Cancer Consortium - Seattle
  • Swedish Medical Center-First Hill - Seattle

Colorado

  • Colorado Blood Cancer Institute - Denver

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2008-06
Est. Completion 2030-01-31
Phase Phase 2
Fred Hutchinson Cancer Center

483 total trials

What the registry record for NCT00716066 still lists

NCT00716066 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 1,506-participant average among 10 other Autoimmune Disease trials with a reported enrollment target (96% lower).

The record links to 10 conditions, with Autoimmune Disease appearing as the primary indexed condition, and to 5 interventions - of which Etoposide is the first listed.

NCT00716066 reports a single indexed study location in Washington, Colorado.

Frequently Asked Questions

What is clinical trial NCT00716066 about?

NCT00716066 is a clinical study titled "Autologous Stem Cell Transplant for Neurologic Autoimmune Diseases". This phase II trial studies the side effects and how well carmustine, etoposide, cytarabine and melphalan together with antithymocyte globulin before a stem cell transplant works in treating patients with autoimmune neurologic disease that did not respond to previous therapy. In autoimmune neurologi...

What is the current status of trial NCT00716066?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2008-06. Estimated completion is 2030-01-31.

What conditions does trial NCT00716066 study?

This clinical trial studies the following conditions: Autoimmune Disease, Stiff Person Syndrome, Neurologic Autoimmune Disease, Autologous Transplant Autoimmune, Multiple Sclerosis Transplant.

What interventions are being tested in trial NCT00716066?

The interventions under investigation include: Etoposide (DRUG), Anti-Thymocyte Globulin (BIOLOGICAL), Cytarabine (DRUG), Carmustine (DRUG), Autologous Hematopoietic Stem Cell Transplantation (PROCEDURE).

Who is sponsoring clinical trial NCT00716066?

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

Where is trial NCT00716066 being conducted?

This trial has 3 study locations across Colorado, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Autoimmune Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00716066's enrollment target sits among peer trials

53 9th of 10 higher than 2 of 10 other Autoimmune Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Autoimmune Disease 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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Related registry views

Source: ClinicalTrials.gov NCT00716066, the US trial registry maintained by the National Library of Medicine. NCT00716066 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.