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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00684255 |
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Date of registration:
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22/05/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc)
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Scientific title:
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Reduced Intensity Conditioning And Allogeneic Stem Cell Transplantation in Patients With Medically Refractory Systemic Lupus Erythematosus and Medically Refractory Systemic Sclerosis (SSc) |
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Date of first enrolment:
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August 2007 |
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Target sample size:
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1 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00684255 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Mitchell Cairo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Columbia University |
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Key inclusion & exclusion criteria
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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%
Age minimum:
7 Years
Age maximum:
50 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Systemic Sclerosis
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Intervention(s)
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Drug: Busulfan
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Drug: Fludarabine
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Drug: Campath
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Procedure: Reduced Intensity Allogeneic Transplant
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Primary Outcome(s)
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Toxicity
[Time Frame: 1 year]
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Secondary Outcome(s)
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Chimerism
[Time Frame: 1 year]
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Progression Free and Overall Survival.
[Time Frame: 1 year]
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Immune Reconstitution.
[Time Frame: 1 year]
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Secondary ID(s)
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CHNY-01-511
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AAAB1324
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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