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

May 22, 2019 updated by: Case Comprehensive Cancer Center

A Study of Hematopoietic Stem Cell Supermobilization in Patients With Non-Hodgkin Lymphoma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Biological: filgrastim
Given SC
Other Names:
  • G-CSF
  • Neupogen
Drug: plerixafor
Given SC
Other Names:
  • Mozobil
  • AMD 3100
Procedure: leukapheresis
Undergo apheresis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 2 days of apheresis
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
Up to 1 year post-transplant
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
Up to 1 year post-transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 28 days post treatment
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.
Up to 28 days post treatment
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.
Up to 28 days post treatment
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)
Up to 1 year post-transplant
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)
Up to 1 year post-transplant
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
Up to 28 days post treatment
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
Up to 28 days post treatment
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.
Up to 28 days post treatment
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.
Up to 28 days post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Navneet Majhail, MD, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

August 1, 2011

First Submitted That Met QC Criteria

August 1, 2011

First Posted (Estimate)

August 3, 2011

Study Record Updates

Last Update Posted (Actual)

June 14, 2019

Last Update Submitted That Met QC Criteria

May 22, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE2410 (Other Identifier: Case Comprehensive Cancer Center)
  • P30CA043703 (U.S. NIH Grant/Contract)
  • NCI-2011-01281 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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