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 Pilot Study of High-Dose Immunosuppression Followed by Infusion of CD34-Selected Autologous or Syngeneic Peripheral Blood Stem Cells for Treatment of Refractory Autoimmune Disorders
Other study identifiers
Sponsor study identifier
Secondary identifiers
OTHER · ORD
interventional
6
1 country
1
Study Start
November 2000
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2010
Actual (reported)Study Completion
May 2011
Actual (reported)Brief 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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- completed
- Actual enrollment (reported)
- 6 participants
- Study completion date
May 2011
Actual (reported)- Listed locations
- 1 countries · 1 sites
Trial Relationships
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Some registry-reported names shown below are not yet linked in this graph.
Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
November 2000
Date type not reportedThis date has not been verified as actual or estimated.
First Submitted
February 2, 2001
Actual (reported)First Posted
February 2, 2001
Actual (reported)Primary Completion
July 2010
Actual (reported)Study Completion
May 2011
Actual (reported)
- Last Updated
- March 6, 2015
- Status Verified
- March 2015
- Last Update Submitted
- March 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality
Annually for 5 years and then every 5 years thereafter
Secondary Outcomes (1)
Immune reconstitution, engraftment, efficacy, late-effects
Annually for 5 years and then every 5 years thereafter
Study Arms (1)
1
EXPERIMENTALParticipants will receive a stem cell transplant.
Interventions
Participants will receive a stem cell transplantation along with irradiation and the drugs anti-thymocyte globulin, cyclophosphamide, and filgrastim as noted in the text of this record.
CD34+ cells are separated from the rest of the peripheral blood stem cells.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Fred Hutchinson Cancer CenterOtherlead
Study Sites (1)
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ann Woolfrey
Fred Hutchinson Cancer Center
- PRINCIPAL INVESTIGATOR
Carol A. Wallace, MD
Fred Hutchinson Cancer Center
Enrollment
6 participants (actual enrollment reported by the registry).
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2001
First Posted
February 2, 2001
Study Start
November 2000
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2010
Actual (reported)Study Completion
May 2011
Actual (reported)Last Updated
March 6, 2015
Record last verified: 2015-03
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
- Registry identifier
- NCT00010335
- Data provider
- ClinicalTrials.gov
- Source updated
- 2015-03-06
- Normalization version
- ctgov-legacy-1
Source retrieved: