Researchers are recruiting patients with severe and active systemic lupus erythematosus to participate in a pilot study involving hemapoietic stem cell transplant.
Potential participants with systemic lupus erythematosus (SLE) should be 15-40 years of age and have acceptable organ function. Participants should have 4 of the 11 American College of Rheumatology criteria for SLE but no other significant medical conditions. Patients may have active and refractory lupus affecting the kidneys, CNS, lungs, or blood. Participants also should have no evidence of malignancy, active hepatitis B virus or hepatitus C virus, or HIV infections. Written consent is required.
The treatment protocol includes priming and conditioning regimens. The priming regimen involves treatment with methylprednisolone, rituximab, cyclophosphamide, and mesna. At the end of this regimen, patients will receive a granulocyte colony-stimulating factor to mobilize stem cells for collection for transplant. Patients will undergo the conditioning regimen immediately prior to stem cell transplant.
Following transplantation, patients will be followed for 6 months and then at 9, 12, 18, and 24 months. After 2 years, patients will be followed yearly for 5 years.
The trial is being conducted at the National Institutes of Health campus in Bethesda, Md. The principal investigator is Dr. Steven Pavletic of the National Institute for Arthritis and Musculoskeletal and Skin Diseases. Physicians who know of interested patients may contact Cheryl Yarboro, R.N., by calling 301-402-6409.