Phase I/II Study of VELCADE®-BEAM and Autologous Hematopoietic Stem Cell Transplantation for Relapsed Indolent Non-Hodgkin's Lymphoma, Transformed or Mantle Cell Lymphoma
Primary Objective: To evaluate in a phase I study the toxicity and MTD of the addition of
VELCADE™ (bortezomib) to a standard BEAM autologous transplant regimen. The phase II
portion of the study will determine a preliminary estimate of the response rate.
Secondary Objectives: To obtain a preliminary estimate of the response rate to this regimen.
To obtain preliminary estimates of event-free and overall survival using this regimen.
Enrolled subjects will receive Velcade in combination with BEAM and Autologous Hematopoietic
Stem Cell Transplantation (AHSCT). Phase I treatment will administer Velcade in four dose
cohorts,in addition to the BEAM and AHSCT. Three patients will be accrued in each dose
cohort with enrollment starting at dose cohort. These subjects will be evaluated to
establish the maximum tolerated dose of Velcade in combination with BEAM autologous
peripheral blood stem cell transplantation. Once established, the maximum tolerated dose
will be utilized in treating an additional 20 subjects.
Follow-Up: Data collected will be utilized to obtain a preliminary estimate of the response
rate, event-free and overall survival using this regimen.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose
Dependent on dose limiting toxicities
Julie M Vose, M.D.
University of Nebraska
United States: Institutional Review Board
|University of Nebraska Medical Center, Section of Oncology/Hematology||Omaha, Nebraska 68198-7680|