Monoclonal Antibody Therapy in Treating Patients With Lymphoproliferative Disorder Associated With Immunosuppression Therapy
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have lymphoproliferative disorder that is associated with immunosuppression therapy.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Trial of Rituximab in Patients With B-Cell Lymphoproliferative Disorders Associated With Pharmacologic Immunosuppression|
|Study Start Date:||March 1998|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003716
|United States, California|
|Stanford University Medical Center|
|Stanford, California, United States, 94305-5408|
|Study Chair:||Sandra J. Horning, MD||Stanford University|