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← Hairy Cell Leukemia

NCT01076270 · STUDY IN CONTEXT

Plerixafor and Filgrastim For Mobilization of Donor Peripheral Blood Stem Cells Before A Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignanc

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

Percentage of donors from whom at least 2 x 10\^6 CD34+ cells/kg body weight were collected based on actual recipient body weight

Study terminated early. Results are for the one donor enrolled.

→

secondary · POSTED

Number of CD34-positive cells collected per kg recipient body weight

Trial terminated; only one patient enrolled

→

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-hairy-cell-leukemia
nct id
NCT01076270
trial label
Plerixafor and Filgrastim For Mobilization of Donor Peripheral Blood Stem Cells Before A Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignanc
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
2
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT01076270
    outcome key
    om-0000
    source section id
    NCT01076270-om-0000
    source outcome index
    0
    endpoint
    Successful Collection of Stem Cells
    endpoint definition
    Percentage of donors from whom at least 2 x 10\^6 CD34+ cells/kg body weight were collected based on actual recipient body weight
    time origin
    At the end of apheresis for cell collection
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Study terminated early. Results are for the one donor enrolled.
    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-hairy-cell-leukemia
    nct id
    NCT01076270
    outcome key
    om-0001
    source section id
    NCT01076270-om-0001
    source outcome index
    1
    endpoint
    CD34-positive Cells Collected
    endpoint definition
    Number of CD34-positive cells collected per kg recipient body weight
    time origin
    At the end of apheresis for cell collection
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Trial terminated; only one patient enrolled
    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-hairy-cell-leukemia
    nct id
    NCT01076270
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Filgrastim and Plerixafor for PBSC Mobilization
    regimen
    Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells. After completion of study treatment, donors are followed up 1 day after the last stem cell donation. plerixafor: Given SC filgrastim: Given SC peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01076270-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT01076270
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Filgrastim and Plerixafor for PBSC Mobilization
    regimen
    Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells. After completion of study treatment, donors are followed up 1 day after the last stem cell donation. plerixafor: Given SC filgrastim: Given SC peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01076270-om-0001#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT01076270
    harm key
    EG000
    source section id
    NCT01076270-ae
    event group key
    EG000
    event group label
    Filgrastim and Plerixafor for PBSC Mobilization
    serious affected
    0
    serious at risk
    1
    other affected
    1
    other at risk
    1
    frequency threshold
    0
    collection period
    From the first dose of study drug to one week after the last clinic visit. The last clinic visit typically occurs the day after stem cell collection is completed.
    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