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

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ClinicalTrials.gov Identifier: NCT01408043
Recruitment Status : Terminated (Slow Accrual)
First Posted : August 3, 2011
Results First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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 : October 2011
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016


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




Primary Outcome Measures :
  1. Collection Using Plerixafor, Etoposide, and Filgrastim [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 1 year post-transplant ]
    Percentage of participants who were alive 1 year after transplant (OS)

  6. Number of Days of Apheresis Required [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 28 days post treatment ]
    Correlation of peripheral CD34+ cell count with graft content of CD34+ cells assessed using Spearman correlation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01408043


Locations
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United States, Ohio
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
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Principal Investigator: Navneet Majhail, MD Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01408043     History of Changes
Other Study ID Numbers: CASE2410
NCI-2011-01281 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE2410 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: August 3, 2011    Key Record Dates
Results First Posted: June 14, 2019
Last Update Posted: June 14, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Mycoses
Burkitt Lymphoma
Lymphoma
Leukemia
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell
Lymphoma, Large-Cell, Immunoblastic
Plasmablastic Lymphoma
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Waldenstrom Macroglobulinemia
Lymphoma, Large-Cell, Anaplastic
Lymphoma, T-Cell, Peripheral
Leukemia, Hairy Cell
Lymphomatoid Granulomatosis
Lymphoma, Extranodal NK-T-Cell
Leukemia, Large Granular Lymphocytic
Immunoblastic Lymphadenopathy
Neoplasms by Histologic Type
Neoplasms