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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00684255
• Other study ID #: AAAB1324
• Secondary ID: CHNY-01-511
• Status: Terminated
• Phase: Phase 1
• First received: May 22, 2008
• Last updated: February 6, 2014
• Start date: August 2007
• Est. completion date: July 2008

Study information

• Verified date: February 2014
• Source: New York Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 50 Years

Eligibility

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%

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Lupus Erythematosus
• Systemic Sclerosis

Intervention

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
• Busulfan
Busulfan 3.2 mg/kg Days _8, -7, -6, -5
• Campath
Campath: 2 mg/m2 Day -5; 6 mg/m2 Day -4, -3; 20 mg/m2 Day -2

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity	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.	1 year	Yes
Secondary	Chimerism	Percentage(%) of mixed and/or complete donor chimerism has been measured at different time points.	1 year	No
Secondary	Immune Reconstitution.	Peripheral blood for immune reconstitution for T-cell, B-cell and NK cells to be obtained for measurement of cell.	1 year	No
Secondary	Progression Free and Overall Survival.	Probability of progression free and overall survival will be measured.	1 year	No

External Links

•   (Click on "Morgan Stanley Children's Hospital" and then "Clinical Services" and then "Blood & Marrow Transplantation")