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Trial record 91 of 170 for:    "Acute Lymphocytic Leukemia" | "Etoposide"

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

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ClinicalTrials.gov Identifier: NCT01408043
Recruitment Status : Terminated (Slow Accrual)
First Posted : August 3, 2011
Results First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Acute Lymphoblastic Leukemia in Remission
Adult Grade III Lymphomatoid Granulomatosis
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
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 Chronic Lymphocytic Leukemia
Refractory Hairy Cell Leukemia
Small Intestine Lymphoma
Splenic Marginal Zone Lymphoma
T-cell Large Granular Lymphocyte Leukemia
Testicular Lymphoma
Waldenström Macroglobulinemia
Interventions Drug: plerixafor
Biological: filgrastim
Drug: etoposide
Procedure: leukapheresis
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Stem Cell Supermobilization)
Hide Arm/Group Description

Patients receive etoposide IV over 4 hours on day 0, filgrastim SC 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.

plerixafor: Given SC

filgrastim: Given SC

etoposide: Given IV

leukapheresis: Undergo apheresis

Period Title: Overall Study
Started 25
Completed 24
Not Completed 1
Reason Not Completed
unable to collect cells             1
Arm/Group Title Treatment (Stem Cell Supermobilization)
Hide Arm/Group Description

Patients receive etoposide IV over 4 hours on day 0, filgrastim SC 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.

plerixafor: Given SC

filgrastim: Given SC

etoposide: Given IV

leukapheresis: Undergo apheresis

Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
Participants enrolled and received intervention.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
62.48  (11.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
4
  16.0%
Male
21
  84.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
25
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   8.0%
White
23
  92.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
1.Primary Outcome
Title Collection Using Plerixafor, Etoposide, and Filgrastim
Hide Description Number of participants able to collect equal to or more than 8 x 10^6 CD34+ cells/kg with addition of plerixafor to etoposide and filgrastim. These participants are defined as supermobilizers. Participants with less than 8 x 10^6 CD34+ cells/kg are defined as normal mobilizers.
Time Frame Within 2 days of apheresis
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that went on study
Arm/Group Title Treatment (Stem Cell Supermobilization)
Hide Arm/Group Description:

Patients receive etoposide IV over 4 hours on day 0, filgrastim SC 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.

plerixafor: Given SC

filgrastim: Given SC

etoposide: Given IV

leukapheresis: Undergo apheresis

Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
Supermobilizers
7
  28.0%
Normal Mobilizers
17
  68.0%
Non mobilizers
1
   4.0%
2.Primary Outcome
Title Progression-free Survival
Hide Description The number of participants of patients who receive greater than or equal to 8 x 10^6 CD34+ cells/kg following collection with plerixafor, etoposide, and filgrastim and that have progression-free survival at one year
Time Frame Up to 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Number of supermobilizer participants that were able to achieve collection of ≥ 8 x 106 CD34+ cells/kg
Arm/Group Title Treatment (Stem Cell Supermobilization)
Hide Arm/Group Description:

Patients receive etoposide IV over 4 hours on day 0, filgrastim SC 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.

plerixafor: Given SC

filgrastim: Given SC

etoposide: Given IV

leukapheresis: Undergo apheresis

Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
7
 100.0%
3.Primary Outcome
Title Overall Survival
Hide Description Number of participants who receive greater than or equal to 8 x 10^6 CD34+ cells/kg by 15% following collection with plerixafor, etoposide, and filgrastimstill alive at 1 yr post transplant
Time Frame Up to 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Number of supermobilizer participants that were able to achieve collection of ≥ 8 x 106 CD34+ cells/kg
Arm/Group Title Treatment (Stem Cell Supermobilization)
Hide Arm/Group Description:

Patients receive etoposide IV over 4 hours on day 0, filgrastim SC 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.

plerixafor: Given SC

filgrastim: Given SC

etoposide: Given IV

leukapheresis: Undergo apheresis

Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
7
 100.0%
4.Secondary Outcome
Title Neutrophil Recovery in Super Mobilizers and Normal Mobilizers
Hide Description Neutrophil recovery in participants receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg entered as the mean cell count of super mobilizers and normal mobilizers.
Time Frame Up to 28 days post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that had some mobilization
Arm/Group Title Treatment (Stem Cell Supermobilization)
Hide Arm/Group Description:

Patients receive etoposide IV over 4 hours on day 0, filgrastim SC 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.

plerixafor: Given SC

filgrastim: Given SC

etoposide: Given IV

leukapheresis: Undergo apheresis

Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: K/ul
Supermobilizers Number Analyzed 7 participants
10.3  (0.5)
Normal Mobilizers Number Analyzed 17 participants
10.2  (0.7)
5.Secondary Outcome
Title Platelet Recovery in Super Mobilizers and Normal Mobilizers
Hide Description Platelet recovery in participants 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that had some mobilization
Arm/Group Title Treatment (Stem Cell Supermobilization)
Hide Arm/Group Description:

Patients receive etoposide IV over 4 hours on day 0, filgrastim SC 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.

plerixafor: Given SC

filgrastim: Given SC

etoposide: Given IV

leukapheresis: Undergo apheresis

Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: percentage of change
Supermobilizers Number Analyzed 7 participants
20.9  (6.5)
Normal Mobilizers Number Analyzed 17 participants
19.8  (5.6)
6.Secondary Outcome
Title Length of Hospital Stay in Super Mobilizers and Normal Mobilizers
Hide Description Length of hospital stay in participants 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that had some mobilization
Arm/Group Title Treatment (Stem Cell Supermobilization)
Hide Arm/Group Description:

Patients receive etoposide IV over 4 hours on day 0, filgrastim SC 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.

plerixafor: Given SC

filgrastim: Given SC

etoposide: Given IV

leukapheresis: Undergo apheresis

Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: days
Supermobilizers Number Analyzed 7 participants
20.7  (0.5)
Normal Mobilizers Number Analyzed 17 participants
22.5  (5.5)
7.Secondary Outcome
Title Progression-free Survival in Supermobilizers and Normal Mobilizers
Hide Description Percentage of participants who were alive and free of progression 1 year after transplant (PFS)
Time Frame Up to 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that had some mobilization
Arm/Group Title Treatment (Stem Cell Supermobilization)
Hide Arm/Group Description:

Patients receive etoposide IV over 4 hours on day 0, filgrastim SC 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.

plerixafor: Given SC

filgrastim: Given SC

etoposide: Given IV

leukapheresis: Undergo apheresis

Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: percent of participants
Supermobilizers Number Analyzed 7 participants
100
Normal Mobilizers Number Analyzed 17 participants
82
8.Secondary Outcome
Title Overall Survival in Supermobilizers and Normal Mobilizers
Hide Description Percentage of participants who were alive 1 year after transplant (OS)
Time Frame Up to 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that had some mobilization
Arm/Group Title Treatment (Stem Cell Supermobilization)
Hide Arm/Group Description:

Patients receive etoposide IV over 4 hours on day 0, filgrastim SC 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.

plerixafor: Given SC

filgrastim: Given SC

etoposide: Given IV

leukapheresis: Undergo apheresis

Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: percent of participants
Supermobilizers Number Analyzed 7 participants
100
Normal Mobilizers Number Analyzed 17 participants
100
9.Secondary Outcome
Title Number of Days of Apheresis Required
Hide Description Number of days of apheresis required to achieve goal in supermobilizers and normal mobilizers
Time Frame Up to 28 days post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were mobilized
Arm/Group Title Treatment (Stem Cell Supermobilization)
Hide Arm/Group Description:

Patients receive etoposide IV over 4 hours on day 0, filgrastim SC 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.

plerixafor: Given SC

filgrastim: Given SC

etoposide: Given IV

leukapheresis: Undergo apheresis

Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: days
Supermobilizers Number Analyzed 7 participants
1.1  (0.4)
Normal Mobilizers Number Analyzed 17 participants
2.9  (1.1)
10.Secondary Outcome
Title Number of Transfusion Requirements
Hide Description Number of transfusions (number of packed red blood cells and platelet transfusions required from day 0 to +28 post-transplant) in supermobilizers and normal mobilizers
Time Frame Up to 28 days post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were mobilized
Arm/Group Title Treatment (Stem Cell Supermobilization)
Hide Arm/Group Description:

Patients receive etoposide IV over 4 hours on day 0, filgrastim SC 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.

plerixafor: Given SC

filgrastim: Given SC

etoposide: Given IV

leukapheresis: Undergo apheresis

Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: transfusions
Supermobilizers Number Analyzed 7 participants
3.7  (2.1)
Normal Mobilizers Number Analyzed 17 participants
4.4  (2.0)
11.Secondary Outcome
Title Need for Remobilization
Hide Description

Number of participants that needed remobilization in supermobilizers and normal mobilizers.

Remobilization can be described as follows:

The first step for patients undergoing autologous hematopoietic cell transplantation is to mobilize hematopoietic progenitor/stem cells from the bone marrow using G-CSF, plerixafor and/or chemotherapy. This is followed by collection of the cells by apheresis. If sufficient number of progenitor/stem cells cannot be mobilized and then collected by apheresis to proceed with transplantation, it is considered as “mobilization failure”. For these patients, mobilization of their hematopoietic progenitor/stem cells is attempted a second time ("remobilization"). The need to do a second 'mobilization' attempt is not ideal.

Time Frame Up to 28 days post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that were mobilized
Arm/Group Title Treatment (Stem Cell Supermobilization)
Hide Arm/Group Description:

Patients receive etoposide IV over 4 hours on day 0, filgrastim SC 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.

plerixafor: Given SC

filgrastim: Given SC

etoposide: Given IV

leukapheresis: Undergo apheresis

Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
Supermobilizers Number Analyzed 7 participants
0
   0.0%
Normal Mobilizers Number Analyzed 17 participants
0
   0.0%
12.Secondary Outcome
Title Correlation of Peripheral CD34+ Cell Count With Graft Content of CD34+ Cells
Hide Description Correlation of peripheral CD34+ cell count with graft content of CD34+ cells assessed using Spearman correlation.
Time Frame Up to 28 days post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
No data collected for this outcome due to low accrual
Arm/Group Title Treatment (Stem Cell Supermobilization)
Hide Arm/Group Description:

Patients receive etoposide IV over 4 hours on day 0, filgrastim SC 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.

plerixafor: Given SC

filgrastim: Given SC

etoposide: Given IV

leukapheresis: Undergo apheresis

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 1 year post-transplant
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Stem Cell Supermobilization)
Hide Arm/Group Description

Patients receive etoposide IV over 4 hours on day 0, filgrastim SC 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.

plerixafor: Given SC

filgrastim: Given SC

etoposide: Given IV

leukapheresis: Undergo apheresis

All-Cause Mortality
Treatment (Stem Cell Supermobilization)
Affected / at Risk (%)
Total   0/25 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Stem Cell Supermobilization)
Affected / at Risk (%)
Total   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Stem Cell Supermobilization)
Affected / at Risk (%)
Total   0/25 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Navneet Majhail
Organization: Case Comprehensive Cancer Center
Phone: 216-444-2199
EMail: majhain@ccf.org
Layout table for additonal information
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01408043     History of Changes
Other Study ID Numbers: CASE2410
NCI-2011-01281 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE2410 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Submitted: August 1, 2011
First Posted: August 3, 2011
Results First Submitted: October 23, 2018
Results First Posted: June 14, 2019
Last Update Posted: June 14, 2019