Brief Title
Etoposide, Filgrastim, and Plerixafor in Improving Stem Cell Mobilization in Treating Patients With Non-Hodgkin Lymphoma
Official Title
A Study of Hematopoietic Stem Cell Supermobilization in Patients With Non-Hodgkin Lymphoma
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.
Study Type
Interventional
Primary Outcome
Collection Using Plerixafor, Etoposide, and Filgrastim
Secondary Outcome
Neutrophil Recovery in Super Mobilizers and Normal Mobilizers
Condition
Adult Acute Lymphoblastic Leukemia in Remission
Intervention
plerixafor
Study Arms / Comparison Groups
Treatment (stem cell supermobilization)
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
25
Start Date
October 2011
Completion Date
May 2016
Primary Completion Date
May 2016
Eligibility Criteria
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
Gender
All
Ages
18 Years - 78 Years
Accepts Healthy Volunteers
No
Contacts
Navneet Majhail, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01408043
Organization ID
CASE2410
Secondary IDs
NCI-2011-01281
Responsible Party
Sponsor
Study Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Navneet Majhail, MD, Principal Investigator, Case Comprehensive Cancer Center
Verification Date
May 2019