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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.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00017641
Date of registration: 06/06/2001
Prospective Registration: Yes
Primary sponsor: Northwestern Memorial Hospital
Public title: Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus
Scientific title:
Date of first enrolment: April 2001
Target sample size: 10
Recruitment status: Active, not recruiting
URL:  http://clinicaltrials.gov/show/NCT00017641
Study type:  Interventional
Study design:  Primary Purpose: Treatment  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     Ann Traynor
Address: 
Telephone:
Email:
Affiliation:  Northwestern Memorial Hospital
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Systemic Lupus Erythematosus
Intervention(s)
Drug: anti-thymocyte globulin
Drug: cyclophosphamide
Drug: filgrastim
Procedure: CD34+ Peripheral Blood Stem Cell Reinfusion
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
199/14976
NU-95LU1
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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