High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic Diseases
PRIMARY OBJECTIVES:
I. Evaluate the safety of high-dose carmustine, etoposide, Ara-c (cytarabine) and melphalan
(BEAM) and Thymoglobulin (antithymocyte globulin) as a high-dose immunosuppressive treatment
(HDIT) regimen in patients with severe, refractory neurological autoimmune disease.
SECONDARY OBJECTIVES:
I. Evaluate disease responses and the duration of response to HDIT and autologous
hematopoietic stem cell transplantation (HSCT).
II. Determine the efficacy and safety of G-CSF (filgrastim) and prednisone or
cyclophosphamide for hematopoietic stem mobilization in patients with neurological
autoimmune diseases.
OUTLINE:
Patients receive carmustine intravenously (IV) on day -6, etoposide IV and cytarabine IV
twice daily (BID) on days -5 to -2, melphalan IV on day -1, and antithymocyte globulin IV on
days -2 and -1. Patients then undergo autologous or syngeneic peripheral blood stem cell
transplant on day 0. Patients also receive prednisone orally (PO) once daily (QD) on days
7-21, followed by 2 week taper.
After completion of study treatment, patients are followed up at 3 months, 1 year, and then
annually thereafter for up to 5 years.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of grades 4-5 regimen-related toxicity as assessed by the Regimen Related Toxicity Scale
Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.3.0. The development of a grade 4 to 5 toxicity of any of the included major organ systems within the first 28 days after transplant will be defined as regimen-related toxicity.
Within 28 days post-transplant
Yes
George Georges
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
2260.00
NCT00716066
June 2008
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Swedish Neuroscience Institute | Seattle, Washington 98122 |
Colorado Blood Cancer Institute | Denver, Colorado 80218 |