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
Results First Received: December 22, 2008  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Systemic Lupus Erythematosus
Systemic Sclerosis
Interventions: Procedure: Reduced Intensity Allogeneic Transplant
Drug: Fludarabine
Drug: Busulfan
Drug: Campath

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study closed due to low accrual.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Reduced Intensity Regimen SSc Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)

Participant Flow:   Overall Study
    Reduced Intensity Regimen SSc  
STARTED     1  
COMPLETED     1  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Systemic Sclerosis (SSc) Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)

Baseline Measures
    Systemic Sclerosis (SSc)  
Number of Participants  
[units: participants]
  1  
Age [1]
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     0  
>=65 years     0  
Gender  
[units: participants]
 
Female     1  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     1  
[1] Subjects 7-17yrs will be enrolled



  Outcome Measures

1.  Primary:   Toxicity   [ Time Frame: 1 year ]

2.  Secondary:   Chimerism   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Immune Reconstitution.   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Progression Free and Overall Survival.   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study closed due to low accrual. Did not meet enrollment goals.


  More Information
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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
e-mail: mitchell_cairo@nymc.edu


No publications provided


Responsible Party: Mitchell Cairo, New York Medical College
ClinicalTrials.gov Identifier: NCT00684255     History of Changes
Other Study ID Numbers: AAAB1324, CHNY-01-511
Study First Received: May 22, 2008
Results First Received: December 22, 2008
Last Updated: February 6, 2014
Health Authority: United States: Food and Drug Administration