Clinical Trial: Etoposide, Filgrastim, and Plerixafor in Improving Stem Cell Mobilization in Treating Patients With Non-Hodgkin Lymphoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Study of Hematopoietic Stem Cell Supermobilization in Patients With Non-Hodgkin Lymphoma

Brief Summary: This clinical trial studies etoposide, filgrastim and plerixafor in improving stem cell mobilization in patients with non-Hodgkin lymphoma. Giving colony-stimulating factors, such as filgrastim, and plerixafor and etoposide together helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored.

Detailed Summary:

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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+ cells.

OUTLINE:

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 o
Sponsor: Case Comprehensive Cancer Center

Current Primary Outcome:

• Improvement of collection of greater than or equal to 8 x 10^6 CD34+ cells/kg by 25% using plerixafor, etoposide, and filgrastim [ Time Frame: Within 2 days of apheresis ]
  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.
• Improvement of progression-free survival of patients who receive greater than or equal to 8 x 10^6 CD34+ cells/kg following collection with plerixafor, etoposide, and filgrastim [ Time Frame: Up to 1 year post-transplant ]
  Relative to 57% of patients mobilizing >= 2 but < 8 x 10^6 CD34+ cells/kg with etoposide and filgrastim alone. Improvement of 20% relative to the historical estimate of 57% would require 45 patients to achieve 5% significance with 80% power.
• Improvement of survival of patients who receive greater than or equal to 8 x 10^6 CD34+ cells/kg by 15% following collection with plerixafor, etoposide, and filgrastim [ Time Frame: Up to 1 year post-transplant ]
  Relative to 68% of patients mobilizing >= 2 but < 8 x 10^6 CD34+ cells/kg with etoposide and filgrastim alone. Improvement of 15% relative to the historical estimate of 68% would require 44 patients to achieve 5% significance with 80% power.

Original Primary Outcome:

• Improvement of collection of greater than or equal to 8 x 10^6 CD34+ cells/kg by 25% using plerixafor, etoposide, and filgrastim [ Time Frame: Within 2 days of apheresis ]
  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.
• Improvement of progression-free survival of patients who receive greater than or equal to 8 x 10^6 CD34+ cells/kg following collection with plerixafor, etoposide, and filgrastim [ Time Frame: Post-transplantation for at least 1 year ]
  Relative to 57% of patients mobilizing >= 2 but < 8 x 10^6 CD34+ cells/kg with etoposide and filgrastim alone. Improvement of 20% relative to the historical estimate of 57% would require 45 patients to achieve 5% significance with 80% power.
• Improvement of survival of patients who receive greater than or equal to 8 x 10^6 CD34+ cells/kg by 15% following collection with plerixafor, etoposide, and filgrastim [ Time Frame: Post-transplantation for at least 1 year ]
  Relative to 68% of patients mobilizing >= 2 but < 8 x 10^6 CD34+ cells/kg with etoposide and filgrastim alone. Improvement of 15% relative to the historical estimate of 68% would require 44 patients to achieve 5% significance with 80% power.

Current Secondary Outcome:

• Comparison of neutrophil recovery, platelet recovery, and length of hospital stay between patients receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg [ Time Frame: Up to 28 days post treatment ]
  Compared using the Wilcoxon rank sum test.
• Comparison of overall survival and progression-free survival between patients receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg [ Time Frame: Up to 1 year post-transplant ]
  Estimated using the Kaplan-Meier method and compared using the log-rank test.
• Comparison of number of days of apheresis required to achieve goal, transfusion requirements, hospitalization costs, and need for remobilization between patients receiving greater than or equal to 8 and less than 8 x 10^6 CD34+cells/kg [ Time Frame: Up to 28 days post treatment ]
  Compared using the Wilcoxon rank sum test; need for remobilization will be compared using the Chi-square test.
• Correlation of peripheral CD34+ cell count with graft content of CD34+ cells [ Time Frame: Up to 28 days post treatment ]
  Assessed using Spearman correlation.

Original Secondary Outcome:

• Comparison of neutrophil recovery, platelet recovery, and length of hospital stay between patients receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg [ Time Frame: Post-transplantation for 1 year ]
  Neutrophil recovery, platelet recovery, and length of hospital stay will be compared between patients receiving >8 x 106 CD34+ cells/kg and <8 x 106 CD34+ cells/kg using the Wilcoxon rank sum test.
• Comparison of overall survival and progression-free survival between patients receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg [ Time Frame: Post-transplantation for at least 1 year ]
• Comparison of number of days of apheresis required to achieve goal, transfusion requirements, hospitalization costs, and need for remobilization between patients receiving greater than or equal to 8 and less than 8 x 10^6 CD34+cells/kg [ Time Frame: Post-transplantation for 1 year ]
  Days of apheresis required to achieve goal, transfusion requirements and hospitalization costs will be compared between patients receiving >8 and <8 x 106 CD34+ cells/kg using the Wilcoxon rank sum test; need for remobilization will be compared using the Chisquare test.
• Correlation of peripheral CD34+ cell count with graft content of CD34+ cells [ Time Frame: Within 2 days of apheresis ]
  The association between peripheral CD34+ cell count and graft content will be assessed using Spearman correlation.

Information By: Case Comprehensive Cancer Center

Dates:
Date Received: August 1, 2011
Date Started: October 2011
Date Completion:
Last Updated: December 6, 2016
Last Verified: December 2016