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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern Memorial Hospital
• Treatments: Antilymphocyte Serum; Cyclophosphamide

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