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

Primary Purpose

Systemic Lupus Erythematosus

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
anti-thymocyte globulin
cyclophosphamide
filgrastim
CD34+ Peripheral Blood Stem Cell Reinfusion
Sponsored by
Northwestern Memorial Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus

Eligibility Criteria

0 Years - 59 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern Memorial Hospital
  • University of Wisconsin Hospital and Clinics

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2001
Last Updated
June 23, 2005
Sponsor
Northwestern Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00017641
Brief Title
Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2003
Overall Recruitment Status
Unknown status
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Northwestern Memorial Hospital

4. Oversight

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
10 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
anti-thymocyte globulin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
filgrastim
Intervention Type
Procedure
Intervention Name(s)
CD34+ Peripheral Blood Stem Cell Reinfusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Traynor
Organizational Affiliation
Northwestern Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-0001
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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