Nonmyeloablative Allo Stem Cell Transplant for Severe Autoimmune Diseases

PHASE1TerminatedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

January 31, 2003

Primary Completion Date

July 31, 2015

Study Completion Date

July 31, 2015

Conditions
Systemic Lupus ErythematosusSystemic Sclerosis
Interventions
PROCEDURE

Nonmyeloablative allogeneic stem cell transplant

Prior to receiving Campath-1H, patients will be premedicated with Benadryl 50 mg IV or PO, and acetaminophen 650 mg orally. Hydrocortisone 100 mg IV is given on the first day of Campath. The preparative regimen will begin on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours. The mixed dosage of chemotherapy may be rounded off to within +/- 5% of the calculated dose, and doses of fludarabine and cyclophosphamide will be based on adjusted ideal body weight. IV hydration and diuretics will be used to maintain adequate urine output during and after administration of cyclophosphamide.

Trial Locations (1)

27705

Duke University Health System, Durham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Duke University

OTHER

NCT00849745 - Nonmyeloablative Allo Stem Cell Transplant for Severe Autoimmune Diseases | Biotech Hunter | Biotech Hunter