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

PHASE1TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

July 31, 2008

Study Completion Date

July 31, 2008

Conditions
Systemic Lupus ErythematosusSystemic Sclerosis
Interventions
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

Trial Locations (1)

10032

Columbia University Medical Center, New York

Sponsors
All Listed Sponsors
lead

New York Medical College

OTHER

NCT00684255 - Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc) | Biotech Hunter | Biotech Hunter