Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE)

• Status: Terminated
• Trial end date: 2017-03-29
• Target enrollment: 0
• Participant gender: All

Summary

The main goal of the study is to determine if bone marrow transplant (BMT) from a less specific pool of donors in combination with high dose cyclophosphamide can induce remission of refractory systemic lupus erythematosus.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Maryland Stem Cell Research Fund
• Treatments: Antilymphocyte Serum; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Mycophenolic Acid; Tacrolimus; Thymoglobulin; Vidarabine

Criteria

Inclusion Criteria:

• Four or more American College of Rheumatology (ACR) criteria for the classification of SLE or 4 or more of the SLICE criteria

• Involvement of one or more of the following organ systems: renal, neurologic, hematologic, cardiac, pulmonary, gastrointestinal

• A lack of response to corticosteroids in moderate-to-high doses, and to either an equivalent degree of immunosuppression with azathioprine, methotrexate, cyclosporin, tacrolimus, belimumab, rituximab, mycophenolate mofetil, and/or appropriate other treatment

• Patients should be eligible for transplantation according to the BMT Policy Manual

Exclusion Criteria:

• Age less than 18 years and over 75 years

• Any risk of pregnancy

• Patients who are preterminal or moribund