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

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ClinicalTrials.gov Identifier: NCT00684255
Recruitment Status : Terminated (inactive)
First Posted : May 26, 2008
Results First Posted : December 2, 2009
Last Update Posted : April 1, 2014
Sponsor:
Information provided by (Responsible Party):
Mitchell Cairo, New York Medical College

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Systemic Lupus Erythematosus
Systemic Sclerosis
Interventions Procedure: Reduced Intensity Allogeneic Transplant
Drug: Fludarabine
Drug: Busulfan
Drug: Campath
Enrollment 1
Recruitment Details Study closed due to low accrual.
Pre-assignment Details  
Arm/Group Title Reduced Intensity Regimen SSc
Hide Arm/Group Description Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Systemic Sclerosis (SSc)
Hide Arm/Group Description Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
1
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
[1]
Measure Description: Subjects 7-17yrs will be enrolled
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Toxicity
Hide Description 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.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medically Refractory Systemic Lupus Erythematosus (SLE) Systemic Sclerosis (SSc)
Hide Arm/Group Description:
Reduced Intensity Regimen of Fludarabine/Busulfan and Campath Followed by alloSCT in patients with Medically Refractory Systemic Lupus Erythematosus (SLE)
Reduced Intensity Regimen of Fludarabine/Busulfan and Campath Followed by alloSCT in patients with Systemic Sclerosis (SSc)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Chimerism
Hide Description Percentage(%) of mixed and/or complete donor chimerism has been measured at different time points.
Time Frame 1 year
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Immune Reconstitution.
Hide Description Peripheral blood for immune reconstitution for T-cell, B-cell and NK cells to be obtained for measurement of cell.
Time Frame 1 year
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Progression Free and Overall Survival.
Hide Description Probability of progression free and overall survival will be measured.
Time Frame 1 year
Outcome Measure Data Not Reported
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Reduced Intensity Regimen SSc
Hide Arm/Group Description Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)
All-Cause Mortality
Reduced Intensity Regimen SSc
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Reduced Intensity Regimen SSc
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Reduced Intensity Regimen SSc
Affected / at Risk (%)
Total   0/1 (0.00%) 
Study closed due to low accrual. Did not meet enrollment goals.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Mitchell S. Cairo
Organization: New York Medical College
Phone: 914-594-3650
Responsible Party: Mitchell Cairo, New York Medical College
ClinicalTrials.gov Identifier: NCT00684255     History of Changes
Other Study ID Numbers: AAAB1324
CHNY-01-511 ( Other Identifier: CU )
First Submitted: May 22, 2008
First Posted: May 26, 2008
Results First Submitted: December 22, 2008
Results First Posted: December 2, 2009
Last Update Posted: April 1, 2014