NCT00684255

Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc)

Reduced Intensity Conditioning And Allogeneic Stem Cell Transplantation in Patients With Medically Refractory Systemic Lupus Erythematosus and Medically Refractory Systemic Sclerosis (SSc)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: New York Medical College · Academic / Other
• Sex: All
• Age: 7 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if a reduced intensity (RI) (non-myeloablative) chemoimmunotherapy followed by Allogeneic Stem Cell Transplantation AlloSCT (matched family donors and matched unrelated cord blood donors) will be well tolerated.

Detailed description

This is to test whether a reduced intensity will result in a high degree of mixed or complete donor chimerism and stabilization of autoimmune disease in a select group of patients with medically refractory SLE or SSc.

Conditions

• Systemic Lupus Erythematosus
• Systemic Sclerosis

Interventions

Type	Name	Description
PROCEDURE	Reduced Intensity Allogeneic Transplant	Eeduced intensity allogeneic stem cell transplantation with a fludarabine/busulfan/alemtuzumab conditioning regimen is anticipated to result in mixed and/or complete donor chimerism and potentially alter the natural history and outcome of patients with medically refractory Systemic Lupus Erythematosus (SLE) or Systemic Sclerosis (SSc).
DRUG	Fludarabine	Fludarabine 30 mg/m2 Day -7, -6, -5, -4, -3, -2
DRUG	Busulfan	Busulfan 3.2 mg/kg Days \_8, -7, -6, -5
DRUG	Campath	Campath: 2 mg/m2 Day -5; 6 mg/m2 Day -4, -3; 20 mg/m2 Day -2

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2008-05-26
• Last updated: 2014-04-01
• Results posted: 2009-12-02

Locations

1 site across 1 country: United States