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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 February 2015 |
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Main ID: |
NCT00017641 |
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Date of registration:
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06/06/2001 |
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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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Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus
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Scientific title:
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Date of first enrolment:
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April 2001 |
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Target sample size:
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10 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00017641 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Treatment
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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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Ann Traynor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Northwestern Memorial Hospital |
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Key inclusion & exclusion criteria
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PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Diagnosis of systemic lupus erythematosus with 1 of the following malignant features:
- Nephritis (WHO class III or IV)
- Failed NIH short-course cyclophosphamide therapy
- Vasculitis/immune complex deposition causing end organ signs or symptoms (e.g.,
cerebritis, transverse myelitis, pulmonary hemorrhage, cardiac failure, or renal
failure)
- Hematologic cytopenias that are immune mediated and uncontrolled by conservative
measures with any of the following:
Transfusion-dependent anemia with untransfused hemoglobin less than 8 g/dL
Platelet count less than 40,000/mm3 (without transfusions)
Granulocyte count less than 1,000/mm3
Catastrophic anti-phospholipid syndrome
--Patient Characteristics--
Cardiovascular:
- LVEF at least 35%
- No lupus-induced myocarditis
- No history of unstable angina
Pulmonary:
- FEV1/FVC at least 50% predicted
- DLCO at least 50% predicted
Other:
- HIV negative
- No prior or concurrent malignancy except localized basal cell or squamous cell skin
cancer
- No uncontrolled diabetes mellitus
- No medical illness that would preclude study
- No psychiatric illness or mental deficiency that would preclude study
- No known hypersensitivity to E. coli-derived proteins
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Age minimum:
N/A
Age maximum:
59 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: cyclophosphamide
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Drug: filgrastim
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Procedure: CD34+ Peripheral Blood Stem Cell Reinfusion
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Drug: anti-thymocyte globulin
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Secondary ID(s)
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199/14976
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NU-95LU1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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