Continuous Infusion Followed by Subcutaneous Injection of Campath-1H Plus Rituximab in the Treatment of CD52- and CD20-Positive Refractory or Relapsed Chronic Lymphoid Disorders
1. To determine the efficacy and response rates of Campath-1H when given as a continuous
intravenous infusion followed by subcutaneous injection plus rituximab in the treatment
of chronic lymphoid disorders that are refractory to conventional therapy, have
relapsed, or have no established frontline therapy.
2. To assess the safety of the combination of Campath-1H when given as a continuous
intravenous infusion followed by subcutaneous injection plus rituximab in chronic
lymphoid disorders that express both CD52 and CD20 cell surface antigens.
3. To measure levels of soluble (s) CD20 and sCD52 as well as levels of Campath-1H,
rituximab and antibody complexes of rituximab/CD20 and Campath-1H/CD52 in patients with
chronic lymphoid disorders treated with Campath-1H plus rituximab.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response categorized as 'Complete Remission,' 'Partial Remission,' or 'No Response.' Blood tests weekly while on active therapy, within 4-6 weeks following last dose of therapy, and every 3 to 6 (+/- month) thereafter as long as on study. Repeat bone marrow biopsy/aspirate with flow cytometry as applicable at the end of first course of therapy, (1 week) within 4-6 weeks following the last dose of therapy and every 6 to 12 months (+/-) thereafter as long as on study.
After each 4 week course of treatment
Alessandra Ferrajoli, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|