Trials / Completed
CompletedNCT00010335
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Fred Hutchinson Cancer Center · Academic / Other
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
PROTOCOL OUTLINE: This is a multicenter study. Patients receive filgrastim (G-CSF) subcutaneously daily until peripheral blood stem cell (PBSC) collection is completed. CD34+ cells are separated from the rest of the PBSCs. Patients undergo total body irradiation twice daily on days -5 and -4. Patients receive anti-thymocyte globulin IV on days -5, -3, -1, 1, 3, and 5 and cyclophosphamide IV on days -3 and -2. CD34-selected PBSCs are reinfused on day 0. Patients receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover. Patients are followed annually for 5 years and then every 5 years thereafter.
Conditions
- Systemic Sclerosis
- Systemic Lupus Erythematosus
- Dermatomyositis
- Juvenile Rheumatoid Arthritis
- Autoimmune Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Stem Cell Transplantation | 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. |
| DEVICE | CD34 selection | CD34+ cells are separated from the rest of the peripheral blood stem cells. |
Timeline
- Start date
- 2000-11-01
- Primary completion
- 2010-07-01
- Completion
- 2011-05-01
- First posted
- 2001-02-02
- Last updated
- 2015-03-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00010335. Inclusion in this directory is not an endorsement.