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

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.

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