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

• Status: Terminated
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York Medical College
• Treatments: Alemtuzumab; Busulfan; Fludarabine; Fludarabine phosphate; Vidarabine

Criteria

Inclusion Criteria:

• Diffuse Systemic Sclerosis and variants as per ACR criteria

• Medically refractory disease

• Adequate Organ Function - Pulmonary function

• Renal function, Cardiac function defined as:

• SGOT (AST) or SGPT (ALT) <5 x upper limit of normal

• Diagnosis of SLE - Medically refractory disease

Exclusion Criteria:

• Karnofsky/Lansky <60%