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Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus

NCT ID: NCT00017641

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Brief Summary

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OBJECTIVES:

I. Determine the safety of immune ablation with high-dose cyclophosphamide and anti-thymocyte globulin followed by peripheral blood stem cell support in patients with systemic lupus erythematosus.

Detailed Description

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PROTOCOL OUTLINE: Patients receive cyclophosphamide IV over 1 hour for 2 doses. Patients receive filgrastim (G-CSF) subcutaneously (SC) beginning 24 hours after completion of cyclophosphamide and continuing until leukapheresis is complete. Leukapheresis continues daily until target number of cells is harvested. CD 34+ cells are isolated from peripheral blood stem cells (PBSC) in vitro.

Patients then receive cyclophosphamide IV over 1 hour on days -5 to -2, anti-thymocyte globulin IV over 10 hours on days -4 to -2, and G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients undergo reinfusion of CD34+ PBSC on day 0.

Patients are followed weekly for 90 days, monthly for 1 year, and at 2 years.

Conditions

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Systemic Lupus Erythematosus

Keywords

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arthritis & connective tissue diseases immunologic disorders and infectious disorders rare disease systemic lupus erythematosus

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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anti-thymocyte globulin

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

filgrastim

Intervention Type DRUG

CD34+ Peripheral Blood Stem Cell Reinfusion

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

0 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern Memorial Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Ann Traynor

Role: STUDY_CHAIR

Northwestern Memorial Hospital

Locations

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Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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NU-95LU1

Identifier Type: -

Identifier Source: secondary_id

199/14976

Identifier Type: -

Identifier Source: org_study_id