Phase II Trial of Rituximab in Patients With B-Cell Lymphoproliferative Disorders Associated With Pharmacologic Immunosuppression
OBJECTIVES: I. Evaluate the efficacy of rituximab in patients with B-cell
lymphoproliferative disorders while under pharmacologic immune suppression for control of
either allograft rejection or autoimmune disease. II. Evaluate the safety and direct
toxicity of rituximab in this patient population, including the potential for opportunistic
infections. III. Evaluate the secondary consequences of rituximab therapy in this
population, including changes in the requirement for immunosuppressive drugs, effects on
graft rejection, graft survival, and severity of autoimmune disease.
OUTLINE: Patients receive rituximab IV over several hours. Treatment repeats every week for
4 courses. Patients are followed every month for 6 months, and then every 3 months until
relapse or 2 years.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 1 year.
Primary Purpose: Treatment
Sandra J. Horning, MD
United States: Federal Government
|Stanford University Medical Center||Stanford, California 94305-5408|