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

Stopped early · Phase 1/Phase 2

Conditions studied: Lupus Erythematosus, Graft-versus-host Disease

In brief

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.

Key facts

Study ID

NCT02080195

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

1

Starts

2016-09-13

Expected to finish

2017-03-29

Last updated by the study team

2019-10-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Age less than 18 years and over 75 years
• Any risk of pregnancy
• Patients who are preterminal or moribund

Where it is running

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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