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

Systemic Lupus Erythematosus Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00017641
• Other study ID #: 199/14976
• Secondary ID: NU-95LU1
• Status: Active, not recruiting
• Phase: Phase 1
• First received: June 6, 2001
• Last updated: June 23, 2005
• Start date: April 2001

Study information

• Verified date: November 2003
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 59 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• anti-thymocyte globulin

• cyclophosphamide

• filgrastim

Procedure:
• CD34+ Peripheral Blood Stem Cell Reinfusion

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern Memorial Hospital

Country where clinical trial is conducted

United States,