Skip to content
Triangle logo TriangleGet started
← Study library

NCT01408043 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
TERMINATED
Registry last update
2019-06-14

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Collection Using Plerixafor, Etoposide, and Filgrastim

→

outcome · POSTED

Progression-free Survival

→

outcome · POSTED

Overall Survival

→

outcome · POSTED

Neutrophil Recovery in Super Mobilizers and Normal Mobilizers

→

outcome · POSTED

Platelet Recovery in Super Mobilizers and Normal Mobilizers

→

outcome · POSTED

Length of Hospital Stay in Super Mobilizers and Normal Mobilizers

→

outcome · POSTED

Progression-free Survival in Supermobilizers and Normal Mobilizers

→

outcome · POSTED

Overall Survival in Supermobilizers and Normal Mobilizers

→

outcome · POSTED

Number of Days of Apheresis Required

→

outcome · POSTED

Number of Transfusion Requirements

→

outcome · POSTED

Need for Remobilization

→

outcome · POSTED

Correlation of Peripheral CD34+ Cell Count With Graft Content of CD34+ Cells

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
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
healthy Volunteers
false
maximum Age
78 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. 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.
    intervention Names
    1. Drug: plerixafor
    2. Biological: filgrastim
    3. Drug: etoposide
    4. Procedure: leukapheresis
    label
    Treatment (stem cell supermobilization)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (stem cell supermobilization)
    description
    Given SC
    name
    plerixafor
    other Names
    1. AMD 3100
    2. Mozobil
    type
    DRUG
  2. arm Group Labels
    1. Treatment (stem cell supermobilization)
    description
    Given SC
    name
    filgrastim
    other Names
    1. G-CSF
    2. Neupogen
    type
    BIOLOGICAL
  3. arm Group Labels
    1. Treatment (stem cell supermobilization)
    description
    Given IV
    name
    etoposide
    other Names
    1. EPEG
    2. VP-16
    3. VP-16-213
    type
    DRUG
  4. arm Group Labels
    1. Treatment (stem cell supermobilization)
    description
    Undergo apheresis
    name
    leukapheresis
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
25
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Collection Using Plerixafor, Etoposide, and Filgrastim
    time Frame
    Within 2 days of apheresis
  2. description
    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
    measure
    Progression-free Survival
    time Frame
    Up to 1 year post-transplant
  3. description
    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
    measure
    Overall Survival
    time Frame
    Up to 1 year post-transplant
secondary Outcomes
  1. description
    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.
    measure
    Neutrophil Recovery in Super Mobilizers and Normal Mobilizers
    time Frame
    Up to 28 days post treatment
  2. description
    Platelet recovery in participants receiving greater than or equal to 8 and less than 8 x 10\^6 CD34+ cells/kg.
    measure
    Platelet Recovery in Super Mobilizers and Normal Mobilizers
    time Frame
    Up to 28 days post treatment
  3. description
    Length of hospital stay in participants receiving greater than or equal to 8 and less than 8 x 10\^6 CD34+ cells/kg.
    measure
    Length of Hospital Stay in Super Mobilizers and Normal Mobilizers
    time Frame
    Up to 28 days post treatment
  4. description
    Percentage of participants who were alive and free of progression 1 year after transplant (PFS)
    measure
    Progression-free Survival in Supermobilizers and Normal Mobilizers
    time Frame
    Up to 1 year post-transplant
  5. description
    Percentage of participants who were alive 1 year after transplant (OS)
    measure
    Overall Survival in Supermobilizers and Normal Mobilizers
    time Frame
    Up to 1 year post-transplant
  6. description
    Number of days of apheresis required to achieve goal in supermobilizers and normal mobilizers
    measure
    Number of Days of Apheresis Required
    time Frame
    Up to 28 days post treatment
  7. description
    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
    measure
    Number of Transfusion Requirements
    time Frame
    Up to 28 days post treatment
  8. description
    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.
    measure
    Need for Remobilization
    time Frame
    Up to 28 days post treatment
  9. description
    Correlation of peripheral CD34+ cell count with graft content of CD34+ cells assessed using Spearman correlation.
    measure
    Correlation of Peripheral CD34+ Cell Count With Graft Content of CD34+ Cells
    time Frame
    Up to 28 days post treatment
Full study description
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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-088259c91a0610e202b5
      requested nct id
      NCT01408043
      primary nct id
      NCT01408043
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      9e542f373b689060c2c6c67507f6e2a629c92470fc1ae13d9359244ba59cb6b8
      payload sha256
      1d883a54363ab38e57f734ab774bcc7a76bada4eb2bc2bc5f0c4d96d70edbdbf
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-088259c91a0610e202b5
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01408043
      occurrences
      1. context exact
        NCT01408043
        end
        11
        exact text
        NCT01408043
        start
        0
      offset unit
      unicode_code_points
      query cond
      Testicular Cancer
      query disease state id
      ds-testicular-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-testicular-cancer-000.json
      source file sha256
      9e542f373b689060c2c6c67507f6e2a629c92470fc1ae13d9359244ba59cb6b8
      source json pointer
      /studies/42/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      88c45b3a6c5400d129aa0c1ca592e36dfb9c87e7e1e3f179da00c6ca9cea2fb9
    2. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-120bb1b76a547827e6e1
      requested nct id
      NCT01408043
      primary nct id
      NCT01408043
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      69c40ed34b17434f684079ec5635264bc5ad292871a86b835704fc99fa9d8157
      payload sha256
      f39bbe0b65ba212ade84e83e75d9f79056f90416798785e52c23e1c0ee9dd2a4
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-120bb1b76a547827e6e1
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01408043
      occurrences
      1. context exact
        NCT01408043
        end
        11
        exact text
        NCT01408043
        start
        0
      offset unit
      unicode_code_points
      query cond
      Small Intestine Cancer
      query disease state id
      ds-small-intestine-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-small-intestine-cancer-000.json
      source file sha256
      69c40ed34b17434f684079ec5635264bc5ad292871a86b835704fc99fa9d8157
      source json pointer
      /studies/86/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      88c45b3a6c5400d129aa0c1ca592e36dfb9c87e7e1e3f179da00c6ca9cea2fb9
    3. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-2877920b5aec0950986f
      requested nct id
      NCT01408043
      primary nct id
      NCT01408043
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      8b9a346048372591e3ee0de631ceead25528dc1d384a69971d454af93b26921d
      payload sha256
      942fd3d434803e40c0391519a6077c1c7f846fe41b8142ae45f0cd65f29511d3
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-2877920b5aec0950986f
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01408043
      occurrences
      1. context exact
        NCT01408043
        end
        11
        exact text
        NCT01408043
        start
        0
      offset unit
      unicode_code_points
      query cond
      Hairy Cell Leukemia
      query disease state id
      ds-hairy-cell-leukemia
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-hairy-cell-leukemia-000.json
      source file sha256
      8b9a346048372591e3ee0de631ceead25528dc1d384a69971d454af93b26921d
      source json pointer
      /studies/37/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      88c45b3a6c5400d129aa0c1ca592e36dfb9c87e7e1e3f179da00c6ca9cea2fb9
    4. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-6b305f9621bf097e39c1
      requested nct id
      NCT01408043
      primary nct id
      NCT01408043
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      6e07dc74a26bd1ade99fcd413dd4628223440282bdf6a9f9a28f6f561038b159
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-6b305f9621bf097e39c1
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01408043
      occurrences
      1. context exact
        NCT01408043
        end
        11
        exact text
        NCT01408043
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/771/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      88c45b3a6c5400d129aa0c1ca592e36dfb9c87e7e1e3f179da00c6ca9cea2fb9
    5. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-72b083dd72c8c27ce370
      requested nct id
      NCT01408043
      primary nct id
      NCT01408043
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
      payload sha256
      c1a8f74b6a88e249793e05b818917fbd5c1b971863b3c6eb26878614f77333e9
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-72b083dd72c8c27ce370
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01408043
      occurrences
      1. context exact
        NCT01408043
        end
        11
        exact text
        NCT01408043
        start
        0
      offset unit
      unicode_code_points
      query cond
      Peripheral T-Cell Non-Hodgkin Lymphoma
      query disease state id
      ds-peripheral-t-cell-non-hodgkin-lymphoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-peripheral-t-cell-non-hodgkin-lymphoma-000.json
      source file sha256
      e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
      source json pointer
      /studies/98/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      88c45b3a6c5400d129aa0c1ca592e36dfb9c87e7e1e3f179da00c6ca9cea2fb9
    6. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-8b1c78203ffb9a917d04
      requested nct id
      NCT01408043
      primary nct id
      NCT01408043
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      a6089e8b15d43633ec778b2a5c464ada1207289beea2ae90de3e4bbe04b32186
      payload sha256
      1cdf613424fa4fa80f6fbb0a1ee0741cd0a94d90a0c076221d48d19625493330
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-8b1c78203ffb9a917d04
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01408043
      occurrences
      1. context exact
        NCT01408043
        end
        11
        exact text
        NCT01408043
        start
        0
      offset unit
      unicode_code_points
      query cond
      Acute Undifferentiated Leukemia
      query disease state id
      ds-acute-undifferentiated-leukemia
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-acute-undifferentiated-leukemia-000.json
      source file sha256
      a6089e8b15d43633ec778b2a5c464ada1207289beea2ae90de3e4bbe04b32186
      source json pointer
      /studies/43/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      88c45b3a6c5400d129aa0c1ca592e36dfb9c87e7e1e3f179da00c6ca9cea2fb9

    Preserved source evidence · Not medical advice