A Study of Hematopoietic Stem Cell Supermobilization in Patients With Non-Hodgkin Lymphoma
I. To determine whether the addition of plerixafor improves the proportion of patients with
lymphoma who collect >= 8 x 10^6 cluster of differentiation (CD)34+ cells/kg within two days
by 25% compared to the historical estimate of 42% with etoposide and G-CSF (filgrastim).
II. To determine whether patients achieving collection of >= 8 x 10^6 CD34+ cells/kg have a
15% one year survival advantage relative to the historical estimate of 68% among patients
mobilizing >= 2 but < 8 x 10^6 CD34+ cells/kg with etoposide and G-CSF.
I. To demonstrate that patients receiving >= 8 x 10^6 CD34+ cells/kg have more rapid
neutrophil and platelet recovery and earlier hospital discharge than those receiving < 8 x
10^6 CD 34+ cells/kg.
II. To compare overall survival and progression-free survival between patients receiving >=
8 x 10^6 CD34+ cells/kg and those receiving < 8 x 10^6 CD34+ cells/kg.
III. To compare number of days of apheresis required to achieve goal, transfusion
requirements, hospitalization costs, need for remobilization between groups.
IV. To evaluate whether peripheral CD34+ cell count correlates with graft content of CD34+
Patients receive etoposide intravenously (IV) over 4 hours on day 0, filgrastim
subcutaneously (SC) once daily (QD) beginning day 1, and plerixafor SC 15-18 hours prior to
apheresis. Patients unable to achieve target collection of >= 8 x 10^6 CD34+ cells/kg
receive another dose of plerixafor followed by apheresis. Following the second apheresis,
patients achieving =< 2 x 10^6 CD34+ cells/kg may continue filgrastim with plerixafor and
continue collection according to the attending physician.
After completion of study treatment, patients are followed up for at least 1 year.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Improvement of collection of greater than or equal to 8 x 10^6 CD34+ cells/kg by 25% using plerixafor, etoposide, and filgrastim
Relative to 42% of patients who collected >= 8 x 10^6 CD34+ cells/kg with etoposide and filgrastim alone. Twenty nine patients would be needed to demonstrate a 25% improvement to 67% based on a one-sided test with 5% significance and 80% power.
Within 2 days of apheresis
Hien Duong, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Federal Government
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|