VELCADE®-BEAM and Autologous Hematopoietic Stem Cell Transplantation for Non-Hodgkin's Lymphoma, or Mantle Cell Lymphoma
This is a Phase I/II trial designed to study the toxicity and Maximum Tolerated Dose of VELCADE in combination with BEAM and autologous hematopoietic stem cell transplantation and to obtain a preliminary estimate of the response rate to this combination.
Mantle Cell Lymphoma
Procedure: autologous peripheral blood stem cell transplantation
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Maximum Tolerated Dose [ Time Frame: Dependent on dose limiting toxicities ] [ Designated as safety issue: Yes ]
- Response rate [ Time Frame: Day 100 ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: from first chemotherapy administered until death ] [ Designated as safety issue: No ]
- event-free survival [ Time Frame: from therapy until relapse, progression, or death from any cause ] [ Designated as safety issue: No ]
|Study Start Date:||April 2006|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: Dose cohort 1 - 4
3 patients will be accrued in each dose cohort. Enrollment will start at Dose Cohort #1. If 0-1 patients experience a dose-limiting toxicity, the next dose cohort will be initiated. Escalation to a higher dose cohort will not commence before 2 patients have achieved engraftment on that dose cohort to evaluate for toxicities.
If 2 of 3 patients in Dose Cohort #1-4 have a dose-limiting toxicity, 3 additional patients will be added to that dose level. If 3 of these 6 patients experience a dose limiting toxicity defined as grade > 2 on the Bearman scale, DLT will be reached. No further dose escalation will take place.
Velcade will be administered in four dose cohorts, 0.8 mg/m², 1.0mg/m², 1.3mg/m² and 1.5mg/m². Three patients will be accrued in each dose cohort with enrollment starting at dose cohort 1, 0.8mg/m². Subjects participating in this study will receive Velcade on Days -11, -8, -5, and -2.
Other Name: VelcadeDrug: BEAM
carmustine 300mg/m2, etoposide 100mg/m2 BID, cytarabine 100mg/m2 BID, melphalan 140mg/m2 BID
Other Names:Procedure: autologous peripheral blood stem cell transplantation
Peripheral blood stem cells will be collected as per the discretion of the treating physician. Once an adequate number of CD34+ cells/kg have been collected (as per existing institutional guidelines) the patient will begin the preparative regimen with for transplant. On day 0 of treatment, the previously stored hematopoietic stem cells will be re-infused. The cells will be removed from the storage freezer, brought to the patient area, thawed in a 370C water bath, and administered intravenously through a central line to the patient. Patients will then be cared for as standard transplant patients.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571493
|United States, Nebraska|
|University of Nebraska Medical Center, Section of Oncology/Hematology|
|Omaha, Nebraska, United States, 68198-7680|
|Study Chair:||Julie M Vose, M.D.||University of Nebraska|