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← Chronic Myeloid Leukemia

NCT00241358 · STUDY IN CONTEXT

Study Evaluating AMD3100 for Transplantation of Sibling Donor Stem Cells in Patients With Hematological Malignancies

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

-Defined as the proportion of donors collecting \>2.0x106 CD34+ cells/kg \[recipient weight\]

Source null

→

primary · POSTED

-Incidence and severity of acute GVHD (aGVHD) will be assessed based on the Seattle criteria

Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells.

→

primary · POSTED

-Defined as neutrophil count ≥ 500/ul following conditioning regimen induced nadir

Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells.

→

secondary · POSTED

-Incidence and severity of chronic GVHD will be assessed based on the Seattle criteria

Only 28 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, receiving non-AMD3100 mobilized cells, or death before day +100.

→

secondary · POSTED

-Death that results from a transplant procedure related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause

Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells.

→

secondary · POSTED

Quality of Life During Stem Cell Mobilization (Recipients Only)

-Quality of life questionnaires were not collected from the recipients.

→

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

Unnamed quality-of-life measure · Quality of Life During Stem Cell Mobilization (Recipients Only)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia
nct id
NCT00241358
qol key
qol-0005
source section id
NCT00241358-om-0005
source outcome index
5
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Quality of Life During Stem Cell Mobilization (Recipients Only)
measure definition
Source null
time frame
48-72 hours after last dose of AMD3100
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
-Quality of life questionnaires were not collected from the recipients.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia
nct id
NCT00241358
trial label
Study Evaluating AMD3100 for Transplantation of Sibling Donor Stem Cells in Patients With Hematological Malignancies
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
2
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00241358
    outcome key
    om-0000
    source section id
    NCT00241358-om-0000
    source outcome index
    0
    endpoint
    Proportion of Donors From Whom a Sufficient Number of Cells for Transplantation Are Collected in no More Than 2 LP Procedures Following Mobilization With AMD3100 (Donor Only)
    endpoint definition
    -Defined as the proportion of donors collecting \>2.0x106 CD34+ cells/kg \[recipient weight\]
    time origin
    Day 1-3
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    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-chronic-myeloid-leukemia
    nct id
    NCT00241358
    outcome key
    om-0001
    source section id
    NCT00241358-om-0001
    source outcome index
    1
    endpoint
    Proportion of Recipients Who Experience Grade 2-4 Acute GVHD (Recipient Only)
    endpoint definition
    -Incidence and severity of acute GVHD (aGVHD) will be assessed based on the Seattle criteria
    time origin
    By Day 100 after transplant
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells.
    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-chronic-myeloid-leukemia
    nct id
    NCT00241358
    outcome key
    om-0002
    source section id
    NCT00241358-om-0002
    source outcome index
    2
    endpoint
    Proportion of Recipients Who Successfully Engraft by Day +21 After Transplant (Recipient Only)
    endpoint definition
    -Defined as neutrophil count ≥ 500/ul following conditioning regimen induced nadir
    time origin
    Day +21
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells.
    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-chronic-myeloid-leukemia
    nct id
    NCT00241358
    outcome key
    om-0003
    source section id
    NCT00241358-om-0003
    source outcome index
    3
    endpoint
    Proportion of Recipients Who Experience Chronic GVHD (Recipient Only)
    endpoint definition
    -Incidence and severity of chronic GVHD will be assessed based on the Seattle criteria
    time origin
    Between Day +100 and +365 post-transplant
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Only 28 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, receiving non-AMD3100 mobilized cells, or death before day +100.
    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-chronic-myeloid-leukemia
    nct id
    NCT00241358
    outcome key
    om-0004
    source section id
    NCT00241358-om-0004
    source outcome index
    4
    endpoint
    Proportion of Recipients Who Experience Mortality Before Day 100 After Transplant (Recipient Only)
    endpoint definition
    -Death that results from a transplant procedure related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause
    time origin
    100 days after transplant
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Only 38 recipients received stem cell products on study. The others were not eligible due to relapse/progression, poor donor collection, or receiving non-AMD3100 mobilized cells.
    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-chronic-myeloid-leukemia
    nct id
    NCT00241358
    outcome key
    om-0005
    source section id
    NCT00241358-om-0005
    source outcome index
    5
    endpoint
    Quality of Life During Stem Cell Mobilization (Recipients Only)
    endpoint definition
    Quality of Life During Stem Cell Mobilization (Recipients Only)
    time origin
    48-72 hours after last dose of AMD3100
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    -Quality of life questionnaires were not collected from the recipients.
    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-chronic-myeloid-leukemia
    nct id
    NCT00241358
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Subcutaneous (SC) Treatment Plan - Donor
    regimen
    * Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis * If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
    analyzed count
    25
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00241358-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00241358
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Recipients
    regimen
    * Conditioning Regimen * Cyclophosphamide 60mg/kg/day on Days -3 and -2 * TBI 550cGy on Day -1 * GVHD prophylaxis \*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100 * PBSC transplant on Day 0
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00241358-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00241358
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Intravenous (IV) Treatment Plan - Donor
    regimen
    * Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis * Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis * If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00241358-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00241358
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Subcutaneous (SC) Treatment Plan - Donor
    regimen
    * Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis * If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00241358-om-0001#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00241358
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Recipients
    regimen
    * Conditioning Regimen * Cyclophosphamide 60mg/kg/day on Days -3 and -2 * TBI 550cGy on Day -1 * GVHD prophylaxis \*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100 * PBSC transplant on Day 0
    analyzed count
    38
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00241358-om-0001#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00241358
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Intravenous (IV) Treatment Plan - Donor
    regimen
    * Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis * Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis * If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00241358-om-0001#groups/OG002
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00241358
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Subcutaneous (SC) Treatment Plan - Donor
    regimen
    * Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis * If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00241358-om-0002#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00241358
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Recipients
    regimen
    * Conditioning Regimen * Cyclophosphamide 60mg/kg/day on Days -3 and -2 * TBI 550cGy on Day -1 * GVHD prophylaxis \*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100 * PBSC transplant on Day 0
    analyzed count
    38
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00241358-om-0002#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00241358
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Intravenous (IV) Treatment Plan - Donor
    regimen
    * Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis * Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis * If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00241358-om-0002#groups/OG002
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00241358
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Subcutaneous (SC) Treatment Plan - Donor
    regimen
    * Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis * If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00241358-om-0003#groups/OG000
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00241358
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Recipients
    regimen
    * Conditioning Regimen * Cyclophosphamide 60mg/kg/day on Days -3 and -2 * TBI 550cGy on Day -1 * GVHD prophylaxis \*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100 * PBSC transplant on Day 0
    analyzed count
    28
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00241358-om-0003#groups/OG001
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00241358
    outcome key
    om-0003
    arm key
    OG002
    arm label
    Intravenous (IV) Treatment Plan - Donor
    regimen
    * Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis * Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis * If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00241358-om-0003#groups/OG002
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00241358
    harm key
    EG000
    source section id
    NCT00241358-ae
    event group key
    EG000
    event group label
    Donors
    serious affected
    2
    serious at risk
    46
    other affected
    46
    other at risk
    46
    frequency threshold
    0
    collection period
    Source null
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00241358
    harm key
    EG001
    source section id
    NCT00241358-ae
    event group key
    EG001
    event group label
    Recipients
    serious affected
    12
    serious at risk
    46
    other affected
    46
    other at risk
    46
    frequency threshold
    0
    collection period
    Source null
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00241358
    qol key
    qol-0005
    source section id
    NCT00241358-om-0005
    source outcome index
    5
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Quality of Life During Stem Cell Mobilization (Recipients Only)
    measure definition
    Source null
    time frame
    48-72 hours after last dose of AMD3100
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    -Quality of life questionnaires were not collected from the recipients.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice