Hematopoietic Stem Cell Support in Vasculitis

Summary

The systemic vasculitis is a wide-ranging group of diseases that are characterized by the presence of blood vessel inflammation (1). Despite this common feature, each type of vasculitis has a unique variety of clinical manifestations that influences its degree of disease severity and ultimately its management. Immunosuppressive therapy forms the foundation of treatment for almost all forms of systemic vasculitis.

The systemic necrotizing vasculitis (SNV) are a subset of vasculitis with significant morbidity and mortality (2). The SNV are Wegener's granulomatosis, allergic angiitis and granulomatosis (AAG) (also known as Churg-Strauss syndrome), polyarteritis nodosum (PAN), microscopic polyangiitis (MPA), and overlap syndrome. In spite of modern therapeutic immune suppressive agents, there remains a not inconsequential morbidity and mortality associated with SNV. The current standard therapy for SNV is chronic oral cyclophosphamide (1-3 mg/kg/day) and corticosteroids (3-6). Transplant doses of cyclophosphamide at 200 mg/kg infused over 4 days is the most common worldwide transplant regimen for systemic lupus erythematosus (SLE) (7). Like SLE, SNV are cyclophosphamide responsive disease. We, therefore, propose a trial of high dose cyclophosphamide with anti-thymocyte globulin (ATG) for patients with SNV.

Conditions

• Vasculitis

Interventions

BIOLOGICAL

Autologous Stem Cell Transplant

Autologous Hematopoietic Stem Cell Transplant will be performed after conditioning

BIOLOGICAL

Allogeneic Stem Cell Transplant

Allogeneic Stem Cell Transplant will be performed after conditioning

DRUG

Cyclophosphamide

Causes prevention of the cell division

DRUG

ATG (rabbit)

A rabbit polyclonal antibody to lymphocyte

DRUG

G-CSF

Hematopoietic growth factor

DRUG

Campath-1h

Humanized monoclonal antibody against CD52 antigen

DRUG

Fludarabine

inhibits DNA synthesis or repair

DRUG

Tacrolimus

immune suppressive drug

DRUG

Mesna

Mesna is a drug used to protect the bladder from the effects of the chemotherapy drugs

Sponsors & Collaborators

• Northwestern University

  lead OTHER

Principal Investigators

• Richard Burt, MD · Northwestern University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

16 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-08-31

Primary Completion

2016-06-30

Completion

2016-06-30

Countries

• United States

Study Locations