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← T-Cell Large Granular Lymphocyte Leukemia

NCT01408043 · STUDY IN CONTEXT

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

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

All participants that went on study

→

primary · POSTED

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

Number of supermobilizer participants that were able to achieve collection of ≥ 8 x 106 CD34+ cells/kg

→

primary · POSTED

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

Number of supermobilizer participants that were able to achieve collection of ≥ 8 x 106 CD34+ cells/kg

→

secondary · POSTED

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.

All participants that had some mobilization

→

secondary · POSTED

Platelet recovery in participants receiving greater than or equal to 8 and less than 8 x 10\^6 CD34+ cells/kg.

All participants that had some mobilization

→

secondary · POSTED

Length of hospital stay in participants receiving greater than or equal to 8 and less than 8 x 10\^6 CD34+ cells/kg.

All participants that had some mobilization

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-t-cell-large-granular-lymphocyte-leukemia
nct id
NCT01408043
trial label
Etoposide, Filgrastim, and Plerixafor in Improving Stem Cell Mobilization in Treating Patients With Non-Hodgkin Lymphoma
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01408043
    outcome key
    om-0000
    source section id
    NCT01408043-om-0000
    source outcome index
    0
    endpoint
    Collection Using Plerixafor, Etoposide, and Filgrastim
    endpoint definition
    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.
    time origin
    Within 2 days of apheresis
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants that went on study
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01408043
    outcome key
    om-0001
    source section id
    NCT01408043-om-0001
    source outcome index
    1
    endpoint
    Progression-free Survival
    endpoint definition
    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
    time origin
    Up to 1 year post-transplant
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Number of supermobilizer participants that were able to achieve collection of ≥ 8 x 106 CD34+ cells/kg
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01408043
    outcome key
    om-0002
    source section id
    NCT01408043-om-0002
    source outcome index
    2
    endpoint
    Overall Survival
    endpoint definition
    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
    time origin
    Up to 1 year post-transplant
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Number of supermobilizer participants that were able to achieve collection of ≥ 8 x 106 CD34+ cells/kg
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01408043
    outcome key
    om-0003
    source section id
    NCT01408043-om-0003
    source outcome index
    3
    endpoint
    Neutrophil Recovery in Super Mobilizers and Normal Mobilizers
    endpoint definition
    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.
    time origin
    Up to 28 days post treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants that had some mobilization
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01408043
    outcome key
    om-0004
    source section id
    NCT01408043-om-0004
    source outcome index
    4
    endpoint
    Platelet Recovery in Super Mobilizers and Normal Mobilizers
    endpoint definition
    Platelet recovery in participants receiving greater than or equal to 8 and less than 8 x 10\^6 CD34+ cells/kg.
    time origin
    Up to 28 days post treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants that had some mobilization
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01408043
    outcome key
    om-0005
    source section id
    NCT01408043-om-0005
    source outcome index
    5
    endpoint
    Length of Hospital Stay in Super Mobilizers and Normal Mobilizers
    endpoint definition
    Length of hospital stay in participants receiving greater than or equal to 8 and less than 8 x 10\^6 CD34+ cells/kg.
    time origin
    Up to 28 days post treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants that had some mobilization
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01408043
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Stem Cell Supermobilization)
    regimen
    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. plerixafor: Given SC filgrastim: Given SC etoposide: Given IV leukapheresis: Undergo apheresis
    analyzed count
    25
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01408043-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01408043
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Stem Cell Supermobilization)
    regimen
    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. plerixafor: Given SC filgrastim: Given SC etoposide: Given IV leukapheresis: Undergo apheresis
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01408043-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01408043
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Stem Cell Supermobilization)
    regimen
    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. plerixafor: Given SC filgrastim: Given SC etoposide: Given IV leukapheresis: Undergo apheresis
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01408043-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01408043
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment (Stem Cell Supermobilization)
    regimen
    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. plerixafor: Given SC filgrastim: Given SC etoposide: Given IV leukapheresis: Undergo apheresis
    analyzed count
    24
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01408043-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01408043
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Treatment (Stem Cell Supermobilization)
    regimen
    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. plerixafor: Given SC filgrastim: Given SC etoposide: Given IV leukapheresis: Undergo apheresis
    analyzed count
    24
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01408043-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01408043
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Treatment (Stem Cell Supermobilization)
    regimen
    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. plerixafor: Given SC filgrastim: Given SC etoposide: Given IV leukapheresis: Undergo apheresis
    analyzed count
    24
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01408043-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-t-cell-large-granular-lymphocyte-leukemia
    nct id
    NCT01408043
    harm key
    EG000
    source section id
    NCT01408043-ae
    event group key
    EG000
    event group label
    Treatment (Stem Cell Supermobilization)
    serious affected
    0
    serious at risk
    25
    other affected
    0
    other at risk
    25
    frequency threshold
    5
    collection period
    Up to 1 year post-transplant
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice