Reduced Intensity Conditioning And Allogeneic Stem Cell Transplantation in Patients With Medically Refractory Systemic Lupus Erythematosus and Medically Refractory Systemic Sclerosis (SSc)
Overview
- Phase
- Phase 1
- Intervention
- Reduced Intensity Allogeneic Transplant
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- New York Medical College
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Toxicity
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
Brief 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.
Investigators
Mitchell Cairo
Principal Investigator
New York Medical College
Eligibility 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%
Arms & Interventions
Reduced Intensity Regimen for Refractory SLE
RI regimen of fludarabine/busulfan and Alemtuzumab (FBA) followed by AlloSCT in selected patients with medically refractory Systemic Lupus Erythematosus (SLE).
Intervention: Reduced Intensity Allogeneic Transplant
Reduced Intensity Regimen for Refractory SLE
RI regimen of fludarabine/busulfan and Alemtuzumab (FBA) followed by AlloSCT in selected patients with medically refractory Systemic Lupus Erythematosus (SLE).
Intervention: Fludarabine
Reduced Intensity Regimen for Refractory SLE
RI regimen of fludarabine/busulfan and Alemtuzumab (FBA) followed by AlloSCT in selected patients with medically refractory Systemic Lupus Erythematosus (SLE).
Intervention: Busulfan
Reduced Intensity Regimen for Refractory SLE
RI regimen of fludarabine/busulfan and Alemtuzumab (FBA) followed by AlloSCT in selected patients with medically refractory Systemic Lupus Erythematosus (SLE).
Intervention: Campath
Reduced Intensity Regimen for SSc
RI regimen of fludarabine/busulfan and Alemtuzumab (FBA) followed by AlloSCT in selected patients with Systemic Sclerosis (SSc).
Intervention: Reduced Intensity Allogeneic Transplant
Reduced Intensity Regimen for SSc
RI regimen of fludarabine/busulfan and Alemtuzumab (FBA) followed by AlloSCT in selected patients with Systemic Sclerosis (SSc).
Intervention: Fludarabine
Reduced Intensity Regimen for SSc
RI regimen of fludarabine/busulfan and Alemtuzumab (FBA) followed by AlloSCT in selected patients with Systemic Sclerosis (SSc).
Intervention: Busulfan
Reduced Intensity Regimen for SSc
RI regimen of fludarabine/busulfan and Alemtuzumab (FBA) followed by AlloSCT in selected patients with Systemic Sclerosis (SSc).
Intervention: Campath
Outcomes
Primary Outcomes
Toxicity
Time Frame: 1 year
Toxicity associated with reduced intensity regimen of fludarabine/busulfan and Campath followed by allogeneic stem cell transplant in patients with medically refractory Systemic Lupus Erythematosus (SLE) or SSc is measured.
Secondary Outcomes
- Chimerism(1 year)
- Immune Reconstitution.(1 year)
- Progression Free and Overall Survival.(1 year)