Trial Outcomes & Findings for Etoposide, Filgrastim, and Plerixafor in Improving Stem Cell Mobilization in Treating Patients With Non-Hodgkin Lymphoma (NCT NCT01408043)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

Within 2 days of apheresis

Results posted on

2019-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Stem Cell Supermobilization) 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 Study STARTED	25
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Stem Cell Supermobilization) 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 Study unable to collect cells	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Stem Cell Supermobilization) n=25 Participants 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
Age, Continuous	62.48 years STANDARD_DEVIATION 11.14 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 2 days of apheresis

Population: All participants that went on study

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.

Outcome measures

Outcome measures
Measure	Treatment (Stem Cell Supermobilization) n=25 Participants 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
Collection Using Plerixafor, Etoposide, and Filgrastim Supermobilizers	7 Participants
Collection Using Plerixafor, Etoposide, and Filgrastim Normal Mobilizers	17 Participants
Collection Using Plerixafor, Etoposide, and Filgrastim Non mobilizers	1 Participants

PRIMARY outcome

Timeframe: Up to 1 year post-transplant

Population: Number of supermobilizer participants that were able to achieve collection of ≥ 8 x 106 CD34+ cells/kg

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

Outcome measures

Outcome measures
Measure	Treatment (Stem Cell Supermobilization) n=7 Participants 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
Progression-free Survival	7 Participants

PRIMARY outcome

Timeframe: Up to 1 year post-transplant

Population: Number of supermobilizer participants that were able to achieve collection of ≥ 8 x 106 CD34+ cells/kg

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

Outcome measures

Outcome measures
Measure	Treatment (Stem Cell Supermobilization) n=7 Participants 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 Survival	7 Participants

SECONDARY outcome

Timeframe: Up to 28 days post treatment

Population: All participants that had some mobilization

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.

Outcome measures

Outcome measures
Measure	Treatment (Stem Cell Supermobilization) n=24 Participants 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
Neutrophil Recovery in Super Mobilizers and Normal Mobilizers Supermobilizers	10.3 K/ul Standard Deviation 0.5
Neutrophil Recovery in Super Mobilizers and Normal Mobilizers Normal Mobilizers	10.2 K/ul Standard Deviation 0.7

SECONDARY outcome

Timeframe: Up to 28 days post treatment

Population: All participants that had some mobilization

Platelet recovery in participants receiving greater than or equal to 8 and less than 8 x 10\^6 CD34+ cells/kg.

Outcome measures

Outcome measures
Measure	Treatment (Stem Cell Supermobilization) n=24 Participants 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
Platelet Recovery in Super Mobilizers and Normal Mobilizers Supermobilizers	20.9 percentage of change Standard Deviation 6.5
Platelet Recovery in Super Mobilizers and Normal Mobilizers Normal Mobilizers	19.8 percentage of change Standard Deviation 5.6

SECONDARY outcome

Timeframe: Up to 28 days post treatment

Population: All participants that had some mobilization

Length of hospital stay in participants receiving greater than or equal to 8 and less than 8 x 10\^6 CD34+ cells/kg.

Outcome measures

Outcome measures
Measure	Treatment (Stem Cell Supermobilization) n=24 Participants 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
Length of Hospital Stay in Super Mobilizers and Normal Mobilizers Supermobilizers	20.7 days Standard Deviation 0.5
Length of Hospital Stay in Super Mobilizers and Normal Mobilizers Normal Mobilizers	22.5 days Standard Deviation 5.5

SECONDARY outcome

Timeframe: Up to 1 year post-transplant

Population: All participants that had some mobilization

Percentage of participants who were alive and free of progression 1 year after transplant (PFS)

Outcome measures

Outcome measures
Measure	Treatment (Stem Cell Supermobilization) n=24 Participants 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
Progression-free Survival in Supermobilizers and Normal Mobilizers Supermobilizers	100 percent of participants
Progression-free Survival in Supermobilizers and Normal Mobilizers Normal Mobilizers	82 percent of participants

SECONDARY outcome

Timeframe: Up to 1 year post-transplant

Population: All participants that had some mobilization

Percentage of participants who were alive 1 year after transplant (OS)

Outcome measures

Outcome measures
Measure	Treatment (Stem Cell Supermobilization) n=24 Participants 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 Survival in Supermobilizers and Normal Mobilizers Supermobilizers	100 percent of participants
Overall Survival in Supermobilizers and Normal Mobilizers Normal Mobilizers	100 percent of participants

SECONDARY outcome

Timeframe: Up to 28 days post treatment

Population: Participants that were mobilized

Number of days of apheresis required to achieve goal in supermobilizers and normal mobilizers

Outcome measures

Outcome measures
Measure	Treatment (Stem Cell Supermobilization) n=24 Participants 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
Number of Days of Apheresis Required Supermobilizers	1.1 days Standard Deviation 0.4
Number of Days of Apheresis Required Normal Mobilizers	2.9 days Standard Deviation 1.1

SECONDARY outcome

Timeframe: Up to 28 days post treatment

Population: Participants that were mobilized

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

Outcome measures

Outcome measures
Measure	Treatment (Stem Cell Supermobilization) n=24 Participants 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
Number of Transfusion Requirements Supermobilizers	3.7 transfusions Standard Deviation 2.1
Number of Transfusion Requirements Normal Mobilizers	4.4 transfusions Standard Deviation 2.0

SECONDARY outcome

Timeframe: Up to 28 days post treatment

Population: Participants that were mobilized

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.

Outcome measures

Outcome measures
Measure	Treatment (Stem Cell Supermobilization) n=24 Participants 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
Need for Remobilization Supermobilizers	0 Participants
Need for Remobilization Normal Mobilizers	0 Participants

SECONDARY outcome

Timeframe: Up to 28 days post treatment

Population: No data collected for this outcome due to low accrual

Correlation of peripheral CD34+ cell count with graft content of CD34+ cells assessed using Spearman correlation.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Stem Cell Supermobilization)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Navneet Majhail

Case Comprehensive Cancer Center

Phone: 216-444-2199

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place