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

This study has been terminated.
(inactive)
Sponsor:
Information provided by (Responsible Party):
Mitchell Cairo, New York Medical College
ClinicalTrials.gov Identifier:
NCT00684255
First received: May 22, 2008
Last updated: February 6, 2014
Last verified: February 2014

May 22, 2008
February 6, 2014
August 2007
July 2008   (final data collection date for primary outcome measure)
Toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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.
To determine the toxicity associated with reduced intensity regmien of fludarabine/busulfan and Campath followed by allogeneic stem cell transplant in patients with medically refractory SLE or SSc [ Time Frame: until end of study ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00684255 on ClinicalTrials.gov Archive Site
  • Chimerism [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Percentage(%) of mixed and/or complete donor chimerism has been measured at different time points.
  • Immune Reconstitution. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Peripheral blood for immune reconstitution for T-cell, B-cell and NK cells to be obtained for measurement of cell.
  • Progression Free and Overall Survival. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Probability of progression free and overall survival will be measured.
  • To quantitate the percent of mixed and/or complete donor chimerism. [ Time Frame: until end of study ] [ Designated as safety issue: No ]
  • To measure immune reconstitution. [ Time Frame: until end of study ] [ Designated as safety issue: No ]
  • To determine the probability of progression free and overall survival. [ Time Frame: Until end of study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Systemic Lupus Erythematosus
  • Systemic Sclerosis
  • 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
    Other Name: Alemtuzumab
  • Experimental: 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).
    Interventions:
    • Procedure: Reduced Intensity Allogeneic Transplant
    • Drug: Fludarabine
    • Drug: Busulfan
    • Drug: Campath
  • Experimental: Reduced Intensity Regimen for SSc
    RI regimen of fludarabine/busulfan and Alemtuzumab (FBA) followed by AlloSCT in selected patients with Systemic Sclerosis (SSc).
    Interventions:
    • Procedure: Reduced Intensity Allogeneic Transplant
    • Drug: Fludarabine
    • Drug: Busulfan
    • Drug: Campath
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
July 2008
July 2008   (final data collection date for primary outcome measure)

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%
Both
7 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00684255
AAAB1324, CHNY-01-511
Yes
Mitchell Cairo, New York Medical College
New York Medical College
Not Provided
Principal Investigator: Mitchell Cairo, MD Columbia University
New York Medical College
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP