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← Chronic Myeloid Leukemia

NCT00038675 · STUDY IN CONTEXT

Therapy of HES, PV, Atypical Chronic Myelocytic Leukemia (CML) or Chronic Myelomonocytic Leukemia (CMML), and Mastocytosis With Imatinib Mesylate

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

Acute myeloid leukemia (AML), Myelodysplastic Syndromes (MDS): CR=Normalization peripheral blood \& bone marrow with 5% or less blasts; normo- or hypercellular marrow; Absolute Neutrophil Count (ANC) \> 1.0 x 10\^9/L, \& platelet count \>100 x 10\^9/L; or CR marrow=As per CR but platelet count \< 100 x 10\^9/L. Agnogenic myeloid metaplasia (AMM) \& CMML: CR=Absence of signs/symptoms of disease; White blood count between 1 to 10 x 10\^9/L with no peripheral blasts, promyelocytes, or myelocytes and normalization of bone marrow (\< 5% blasts in normocellular or hypercellular marrow) for 4+ weeks. PV: CR=normalization of hemoglobin/hematocrit without need for phlebotomies, disappearance all signs/symptoms of disease. HES: CR=disappearance of eosinophilia (\</=10%), disappearance signs/symptoms of disease. Mastocytosis: CR=disappearance of mast cell infiltrates in affected organs, decrease of serum tyrptase levels to \<20 ng/ml, \& disappearance of SM-associated organomegaly.

Source null

→

secondary · POSTED

Time from response to disease progression, measuring length of the response in those participants who responded.

Source null

→

secondary · POSTED

Overall survival defined as time from registration to disease progression or death from any cause.

Source null

→

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-chronic-myeloid-leukemia
nct id
NCT00038675
trial label
Therapy of HES, PV, Atypical Chronic Myelocytic Leukemia (CML) or Chronic Myelomonocytic Leukemia (CMML), and Mastocytosis With Imatinib Mesylate
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
3
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00038675
    outcome key
    om-0000
    source section id
    NCT00038675-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With a Complete Response (CR)
    endpoint definition
    Acute myeloid leukemia (AML), Myelodysplastic Syndromes (MDS): CR=Normalization peripheral blood \& bone marrow with 5% or less blasts; normo- or hypercellular marrow; Absolute Neutrophil Count (ANC) \> 1.0 x 10\^9/L, \& platelet count \>100 x 10\^9/L; or CR marrow=As per CR but platelet count \< 100 x 10\^9/L. Agnogenic myeloid metaplasia (AMM) \& CMML: CR=Absence of signs/symptoms of disease; White blood count between 1 to 10 x 10\^9/L with no peripheral blasts, promyelocytes, or myelocytes and normalization of bone marrow (\< 5% blasts in normocellular or hypercellular marrow) for 4+ weeks. PV: CR=normalization of hemoglobin/hematocrit without need for phlebotomies, disappearance all signs/symptoms of disease. HES: CR=disappearance of eosinophilia (\</=10%), disappearance signs/symptoms of disease. Mastocytosis: CR=disappearance of mast cell infiltrates in affected organs, decrease of serum tyrptase levels to \<20 ng/ml, \& disappearance of SM-associated organomegaly.
    time origin
    after 2 months of therapy, up to 1 year.
    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
    NCT00038675
    outcome key
    om-0001
    source section id
    NCT00038675-om-0001
    source outcome index
    1
    endpoint
    Duration of Response
    endpoint definition
    Time from response to disease progression, measuring length of the response in those participants who responded.
    time origin
    From response evaluation (first evaluation following 2 months therapy) to disease progression or death or until disease progression whichever occurs first, up to 12 years and 5 months
    analysis role
    secondary
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00038675
    outcome key
    om-0002
    source section id
    NCT00038675-om-0002
    source outcome index
    2
    endpoint
    Overall Survival
    endpoint definition
    Overall survival defined as time from registration to disease progression or death from any cause.
    time origin
    From the start of therapy to death or disease progression, assessed up to 12 years and 5 months
    analysis role
    secondary
    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
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00038675
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Imatinib Mesylate
    regimen
    Imatinib mesylate 400 mg orally daily, HES participants start with 100 mg orally daily.
    analyzed count
    125
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00038675-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00038675
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Imatinib Mesylate
    regimen
    Imatinib mesylate 400 mg orally daily, HES participants start with 100 mg orally daily.
    analyzed count
    125
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00038675-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00038675
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Imatinib Mesylate
    regimen
    Imatinib mesylate 400 mg orally daily, HES participants start with 100 mg orally daily.
    analyzed count
    125
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00038675-om-0002#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00038675
    harm key
    EG000
    source section id
    NCT00038675-ae
    event group key
    EG000
    event group label
    Imatinib Mesylate
    serious affected
    13
    serious at risk
    125
    other affected
    0
    other at risk
    125
    frequency threshold
    5
    collection period
    Adverse Event collection from first treatment through 30 days following last treatment, treatment may continue up to one year without disease progression.
    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