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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Case Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01408043
First received: August 1, 2011
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Hematopoietic Stem Cell Supermobilization in Patients With Non-Hodgkin Lymphoma

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Improvement of collection of greater than or equal to 8 x 10^6 CD34+ cells/kg by 25% using plerixafor, etoposide, and filgrastim [ Time Frame: Within 2 days of apheresis ] [ Designated as safety issue: No ]
    Relative to 42% of patients who collected >= 8 x 10^6 CD34+ cells/kg with etoposide and filgrastim alone. Twenty nine patients would be needed to demonstrate a 25% improvement to 67% based on a one-sided test with 5% significance and 80% power.

  • Improvement of progression-free survival of patients who receive greater than or equal to 8 x 10^6 CD34+ cells/kg following collection with plerixafor, etoposide, and filgrastim [ Time Frame: Up to 1 year post-transplant ] [ Designated as safety issue: No ]
    Relative to 57% of patients mobilizing >= 2 but < 8 x 10^6 CD34+ cells/kg with etoposide and filgrastim alone. Improvement of 20% relative to the historical estimate of 57% would require 45 patients to achieve 5% significance with 80% power.

  • Improvement of survival of patients who receive greater than or equal to 8 x 10^6 CD34+ cells/kg by 15% following collection with plerixafor, etoposide, and filgrastim [ Time Frame: Up to 1 year post-transplant ] [ Designated as safety issue: No ]
    Relative to 68% of patients mobilizing >= 2 but < 8 x 10^6 CD34+ cells/kg with etoposide and filgrastim alone. Improvement of 15% relative to the historical estimate of 68% would require 44 patients to achieve 5% significance with 80% power.


Secondary Outcome Measures:
  • Comparison of neutrophil recovery, platelet recovery, and length of hospital stay between patients 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 ] [ Designated as safety issue: No ]
    Compared using the Wilcoxon rank sum test.

  • Comparison of overall survival and progression-free survival between patients receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg [ Time Frame: Up to 1 year post-transplant ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method and compared using the log-rank test.

  • Comparison of number of days of apheresis required to achieve goal, transfusion requirements, hospitalization costs, and need for remobilization between patients 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 ] [ Designated as safety issue: No ]
    Compared using the Wilcoxon rank sum test; need for remobilization will be compared using the Chi-square test.

  • Correlation of peripheral CD34+ cell count with graft content of CD34+ cells [ Time Frame: Up to 28 days post treatment ] [ Designated as safety issue: No ]
    Assessed using Spearman correlation.


Estimated Enrollment: 70
Study Start Date: October 2011
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have biopsy-confirmed non-Hodgkin lymphoma, of any type
  • Be in first or second complete or partial remission
  • 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
  • >= 3 weeks since last cycle of chemotherapy
  • Negative for human immunodeficiency virus (HIV)
  • White blood cell count >= 2.5 x 10^9/L
  • 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 > 3 prior regimens for treatment of non-Hodgkin lymphoma
  • Have had previous radiation of the pelvic area
  • Have had prior radioimmunotherapy
  • Have received G-CSF or other growth factors within 14 days of the etoposide dose
  • Have received experimental therapy within 4 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408043

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Hien K. Duong    216-444-2529    duongh@ccf.org   
Principal Investigator: Hien K. Duong         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Hien Duong Case Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01408043     History of Changes
Other Study ID Numbers: CASE2410, NCI-2011-01281, CASE2410, P30CA043703
Study First Received: August 1, 2011
Last Updated: February 7, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Burkitt Lymphoma
Immunoblastic Lymphadenopathy
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Hairy Cell
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Lymphoma
Lymphoma, Follicular
Lymphomatoid Granulomatosis
Waldenstrom Macroglobulinemia
Mycoses
Mycosis Fungoides
Sezary Syndrome
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell, Peripheral
Lymphoma, Large-Cell, Anaplastic
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Extranodal NK-T-Cell
Lymphoma, Mantle-Cell
Leukemia, Large Granular Lymphocytic
Epstein-Barr Virus Infections
Herpesviridae Infections

ClinicalTrials.gov processed this record on July 28, 2014