Clinical Trials Directory

Trials / Terminated

TerminatedNCT01408043

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

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
25 (actual)
Sponsor
Case Comprehensive Cancer Center · Academic / Other
Sex
All
Age
18 Years – 78 Years
Healthy volunteers
Not accepted

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 description

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 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 at 28 days and then for at least 1 year.

Conditions

Interventions

TypeNameDescription
DRUGplerixaforGiven SC
BIOLOGICALfilgrastimGiven SC
DRUGetoposideGiven IV
PROCEDUREleukapheresisUndergo apheresis

Timeline

Start date
2011-10-01
Primary completion
2016-05-01
Completion
2016-05-01
First posted
2011-08-03
Last updated
2019-06-14
Results posted
2019-06-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01408043. Inclusion in this directory is not an endorsement.