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

Sponsored by:	Northwestern Memorial Hospital
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00017641

Purpose

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.

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: filgrastim Procedure: CD34+ Peripheral Blood Stem Cell Reinfusion	Phase I

MedlinePlus related topics: Lupus

Drug Information available for: Cyclophosphamide Filgrastim

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	10
Study Start Date:	April 2001

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.

Eligibility

Ages Eligible for Study:	up to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017641

Locations

United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792-0001

Sponsors and Collaborators

Northwestern Memorial Hospital

Investigators

Study Chair:

Ann Traynor

Northwestern Memorial Hospital

More Information

Study ID Numbers:	199/14976, NU-95LU1
Study First Received:	June 6, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00017641
Health Authority:	Unspecified

Keywords provided by Office of Rare Diseases (ORD):

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

Study placed in the following topic categories:

Antilymphocyte Serum
Autoimmune Diseases
Lupus Erythematosus, Systemic
Arthritis

Rare Diseases
Connective Tissue Diseases
Cyclophosphamide

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009