NCT00017641

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2001

Completed
Same day until next milestone

First Posted

Study publicly available on registry

June 6, 2001

Completed
Last Updated

June 24, 2005

Status Verified

November 1, 2003

First QC Date

June 6, 2001

Last Update Submit

June 23, 2005

Conditions

Systemic Lupus Erythematosus

Keywords

arthritis & connective tissue diseasesimmunologic disorders and infectious disordersrare diseasesystemic lupus erythematosus

Interventions

anti-thymocyte globulinDRUG
cyclophosphamideDRUG
filgrastimDRUG
CD34+ Peripheral Blood Stem Cell ReinfusionPROCEDURE

Eligibility Criteria

Age0 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792-0001, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, SystemicArthritisConnective Tissue DiseasesImmune System DiseasesCommunicable DiseasesRare Diseases

Interventions

Antilymphocyte SerumCyclophosphamideFilgrastim

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesAutoimmune DiseasesJoint DiseasesMusculoskeletal DiseasesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex MixturesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsGranulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesBiological Factors

Study Officials

  • Ann Traynor

    Northwestern Memorial Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2001

First Posted

June 6, 2001

Study Start

April 1, 2001

Last Updated

June 24, 2005

Record last verified: 2003-11

Locations

US(2)