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

• Sponsor: Case Comprehensive Cancer Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01408043
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 25
• Location: 1
• Arm: 1
• Duration (Months): 55
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Drug: plerixafor; Biological: filgrastim; Drug: etoposide; Procedure: leukapheresis	N/A

Detailed Description

PRIMARY OBJECTIVES:

1. 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).

2. 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:

1. 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.

2. 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.

3. To compare number of days of apheresis required to achieve goal, transfusion requirements, hospitalization costs, need for remobilization between groups.

4. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study of Hematopoietic Stem Cell Supermobilization in Patients With Non-Hodgkin Lymphoma
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

Drug: plerixafor; Given SC; Other Names: AMD 3100 Mozobil ; Biological: filgrastim; Given SC; Other Names: G-CSF Neupogen ; Drug: etoposide; Given IV; Other Names: EPEG VP-16 VP-16-213 ; Procedure: leukapheresis; Undergo apheresis

Outcome Measures

Primary Outcome Measures

1. Collection Using Plerixafor, Etoposide, and Filgrastim [Within 2 days of apheresis]

   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.

2. Progression-free Survival [Up to 1 year post-transplant]

   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

3. Overall Survival [Up to 1 year post-transplant]

   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

Secondary Outcome Measures

1. Neutrophil Recovery in Super Mobilizers and Normal Mobilizers [Up to 28 days post treatment]

   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.

2. Platelet Recovery in Super Mobilizers and Normal Mobilizers [Up to 28 days post treatment]

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

3. Length of Hospital Stay in Super Mobilizers and Normal Mobilizers [Up to 28 days post treatment]

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

4. Progression-free Survival in Supermobilizers and Normal Mobilizers [Up to 1 year post-transplant]

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

5. Overall Survival in Supermobilizers and Normal Mobilizers [Up to 1 year post-transplant]

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

6. Number of Days of Apheresis Required [Up to 28 days post treatment]

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

7. Number of Transfusion Requirements [Up to 28 days post treatment]

   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

8. Need for Remobilization [Up to 28 days post treatment]

   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.

9. Correlation of Peripheral CD34+ Cell Count With Graft Content of CD34+ Cells [Up to 28 days post treatment]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 78 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have biopsy-confirmed non-Hodgkin lymphoma, of any type

• Must be eligible for autologous transplantation according to institutional guidelines

• Eastern Cooperative Oncology Group performance status of 0 or 1

• Karnofsky performance status of 70 to 100

• Negative for human immunodeficiency virus (HIV)

• prior to the start of mobilization, subjects must have:

• Absolute neutrophil count of >= 1.2 x 10^9/L

• Platelet count of >= 100 x 10^9/L

• Creatinine clearance >= 30 mL/minute

• All patients must be able to comprehend and sign informed consent

• If childbearing potential must either agree to complete abstinence from heterosexual intercourse or effective means of contraception during stem cell mobilization and for at least 3 months following last plerixafor dose; female patients will undergo pregnancy test prior to stem cell mobilization therapy

Exclusion Criteria:

• Have had previous transplants and/or prior mobilization attempts

• Have evidence of progressive non-Hodgkin lymphoma

• Have evidence of bone marrow involvement of lymphoma at time of transplant staging

• Had evidence of active central nervous system (CNS) involvement

• Have had previous radiation of the pelvic area

• Have had prior radioimmunotherapy

• Have received experimental therapy within 2 weeks of enrollment

• Be currently enrolled in another investigational protocol

• Have prior history of other malignancies, excluding basal cell carcinoma or squamous cell carcinoma of the skin

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• Case Comprehensive Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Navneet Majhail, MD, Case Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Case Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT01408043
• Other Study ID Numbers: CASE2410; NCI-2011-01281; CASE2410; P30CA043703
• First Posted: Aug 3, 2011
• Last Update Posted: Jun 14, 2019
• Last Verified: May 1, 2019

• Additional relevant MeSH terms: Burkitt Lymphoma; Mycoses; Lymphoma; Leukemia; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Plasmablastic Lymphoma; Mycosis Fungoides; Sezary Syndrome; Leukemia, T-Cell; Lymphoma, T-Cell, Cutaneous; Leukemia-Lymphoma, Adult T-Cell; Waldenstrom Macroglobulinemia; Lymphoma, Large-Cell, Anaplastic; Leukemia, Hairy Cell; Lymphomatoid Granulomatosis; Lymphoma, Extranodal NK-T-Cell; Leukemia, Large Granular Lymphocytic; Immunoblastic Lymphadenopathy; Recurrence; Plerixafor; Etoposide; Etoposide phosphate

Study Results

Participant Flow

Arm/Group Title	Treatment (Stem Cell Supermobilization)
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

Baseline Characteristics

Arm/Group Title	Treatment (Stem Cell Supermobilization)
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 Participants	25
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.48 (11.14)
Sex: Female, Male (Count of Participants)
Female	4 16%
Male	21 84%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	25 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 8%
White	23 92%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	25 100%

Outcome Measures

1. Primary Outcome

Title	Collection Using Plerixafor, Etoposide, and Filgrastim
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

Outcome Measure Data

Analysis Population Description

All participants that went on study

Arm/Group Title	Treatment (Stem Cell Supermobilization)
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
Measure Participants	25
Supermobilizers	7 28%
Normal Mobilizers	17 68%
Non mobilizers	1 4%

2. Primary Outcome

Title	Progression-free Survival
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

Outcome Measure Data

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)
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
Measure Participants	7
Count of Participants [Participants]	7 28%

3. Primary Outcome

Title	Overall Survival
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

Outcome Measure Data

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)
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
Measure Participants	7
Count of Participants [Participants]	7 28%

4. Secondary Outcome

Title	Neutrophil Recovery in Super Mobilizers and Normal Mobilizers
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

Outcome Measure Data

Analysis Population Description

All participants that had some mobilization

Arm/Group Title	Treatment (Stem Cell Supermobilization)
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
Measure Participants	24
Supermobilizers	10.3 (0.5)
Normal Mobilizers	10.2 (0.7)

5. Secondary Outcome

Title	Platelet Recovery in Super Mobilizers and Normal Mobilizers
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

Outcome Measure Data

Analysis Population Description

All participants that had some mobilization

Arm/Group Title	Treatment (Stem Cell Supermobilization)
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
Measure Participants	24
Supermobilizers	20.9 (6.5)
Normal Mobilizers	19.8 (5.6)

6. Secondary Outcome

Title	Length of Hospital Stay in Super Mobilizers and Normal Mobilizers
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

Outcome Measure Data

Analysis Population Description

All participants that had some mobilization

Arm/Group Title	Treatment (Stem Cell Supermobilization)
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
Measure Participants	24
Supermobilizers	20.7 (0.5)
Normal Mobilizers	22.5 (5.5)

7. Secondary Outcome

Title	Progression-free Survival in Supermobilizers and Normal Mobilizers
Description	Percentage of participants who were alive and free of progression 1 year after transplant (PFS)
Time Frame	Up to 1 year post-transplant

Outcome Measure Data

Analysis Population Description

All participants that had some mobilization

Arm/Group Title	Treatment (Stem Cell Supermobilization)
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
Measure Participants	24
Supermobilizers	100 400%
Normal Mobilizers	82 328%

8. Secondary Outcome

Title	Overall Survival in Supermobilizers and Normal Mobilizers
Description	Percentage of participants who were alive 1 year after transplant (OS)
Time Frame	Up to 1 year post-transplant

Outcome Measure Data

Analysis Population Description

All participants that had some mobilization

Arm/Group Title	Treatment (Stem Cell Supermobilization)
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
Measure Participants	24
Supermobilizers	100 400%
Normal Mobilizers	100 400%

9. Secondary Outcome

Title	Number of Days of Apheresis Required
Description	Number of days of apheresis required to achieve goal in supermobilizers and normal mobilizers
Time Frame	Up to 28 days post treatment

Outcome Measure Data

Analysis Population Description

Participants that were mobilized

Arm/Group Title	Treatment (Stem Cell Supermobilization)
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
Measure Participants	24
Supermobilizers	1.1 (0.4)
Normal Mobilizers	2.9 (1.1)

10. Secondary Outcome

Title	Number of Transfusion Requirements
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

Outcome Measure Data

Analysis Population Description

Participants that were mobilized

Arm/Group Title	Treatment (Stem Cell Supermobilization)
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
Measure Participants	24
Supermobilizers	3.7 (2.1)
Normal Mobilizers	4.4 (2.0)

11. Secondary Outcome

Title	Need for Remobilization
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

Outcome Measure Data

Analysis Population Description

Participants that were mobilized

Arm/Group Title	Treatment (Stem Cell Supermobilization)
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
Measure Participants	24
Supermobilizers	0 0%
Normal Mobilizers	0 0%

12. Secondary Outcome

Title	Correlation of Peripheral CD34+ Cell Count With Graft Content of CD34+ Cells
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

Outcome Measure Data

Analysis Population Description

No data collected for this outcome due to low accrual

Arm/Group Title	Treatment (Stem Cell Supermobilization)
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
Measure Participants	0

Adverse Events

Time Frame	Up to 1 year post-transplant
Arm/Group Title	Treatment (Stem Cell Supermobilization)
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 (%)	# Events
Total	0/25 (0%)
Serious Adverse Events
	Treatment (Stem Cell Supermobilization)
	Affected / at Risk (%)	# Events
Total	0/25 (0%)
Other (Not Including Serious) Adverse Events
	Treatment (Stem Cell Supermobilization)
	Affected / at Risk (%)	# Events
Total	0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.