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

This study is currently recruiting participants.
Verified April 2012 by Case Comprehensive Cancer Center

First Received on August 1, 2011.  
Last Updated on April 10, 2012  
History of Changes
This Clinical Trial Sponsored By: Case Comprehensive Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by (Responsible Party): Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01408043
 

Purpose for Clinical Trial

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

Condition Study Intervention
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Cutaneous B-cell Non-Hodgkin Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Hepatosplenic T-cell Lymphoma
Intraocular Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Noncutaneous Extranodal Lymphoma
Peripheral T-cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Refractory Hairy Cell Leukemia
Small Intestine Lymphoma
Splenic Marginal Zone Lymphoma
T-cell Large Granular Lymphocyte Leukemia
Testicular Lymphoma
Waldenstrom Macroglobulinemia
Drug: plerixafor
Biological: filgrastim
Drug: etoposide
Procedure: leukapheresis

Study Type: Study Interventional
Study Design: Endpoint Classification: Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Hematopoietic Stem Cell Supermobilization in Patients With Non-Hodgkin Lymphoma

Resource links provided by NLM:

Genetics Home Reference related topics:
aceruloplasminemia
hemophilia
MedlinePlus related topics:
Cancer
Fungal Infections
Leukemia
Lymphoma
Drug Information available for:
Etoposide
Plerixafor
Etoposide phosphate
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor

U.S. FDA Resources

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures For Clinical Trial:

  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

Secondary Outcome Measures For Clinical Trial:

  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The association between peripheral CD34+ cell count and graft content will be assessed using Spearman correlation.

Estimated Enrollment: 70
Study Start Date: October 2011
Estimated Primary Completion Date:

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