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

Not Applicable

Terminated

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
Hepatosplenic T-cell Lymphoma
Cutaneous B-cell Non-Hodgkin Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Noncutaneous Extranodal Lymphoma

Interventions: Drug: plerixafor
Biological: filgrastim
Drug: etoposide
Procedure: leukapheresis

Registration Number: NCT01408043

Lead Sponsor: Case Comprehensive Cancer Center

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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 25

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (stem cell supermobilization)	filgrastim	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.
Treatment (stem cell supermobilization)	leukapheresis	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.
Treatment (stem cell supermobilization)	etoposide	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.
Treatment (stem cell supermobilization)	plerixafor	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.

Primary Outcome Measures

Name	Time	Method
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
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.
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

Secondary Outcome Measures

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