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← Acute Myeloid Leukemia

NCT00136084 · STUDY IN CONTEXT

Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia

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 because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

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

Detection of Minimal Residual Disease following one course of chemotherapy where positive MRD was defined as one or more leukemic cell per 1000 mononuclear bone-marrow cells (\>=0.1%).

Of the 223 randomized patients, 205 patients were included in the day 22 MRD analysis. 18 patients were not included in the day 22 MRD analysis. 5 patients had inadequate sample for MRD, 11 patients had no suitable phenotype to determine MRD, 1 patient was not done on MRD, and 1 patient was lost for follow-up.

→

secondary · POSTED

To estimate the proportion of minimal residual disease (MRD)+ patients who become MRD- after one course of gemtuzumab ozogamicin (GO)

Sixteen patients received GO treatment during consolidation I. One patient with negative MRD received GO treatment, which was not consistent with the protocol definition. 15 patients were analyzed. Out of the 15 patients, 7 patients were treated on HDAC arm and 8 patients were treated on LDAC arm.

→

secondary · POSTED

To estimate proportion of patients with MRD reduction after one course of Induction II (cytarabine + daunomycin + etoposide (ADE) + GO), who had no response to first course of induction therapy.

Out of the 30 patients received ADE + GO treatment, one patient had inevaluable MRD prior to and after the treatment. 29 patients were analyzed. Out of the 29 patients, 10 patients were treated on HDAC arm and 19 patients were treated on LDAC arm.

→

secondary · POSTED

To estimate proportion of patients experiencing CTC Grade 3 or 4 toxicity during Induction II (Cytarabine + Daunomycin + Etoposide (ADE) + GO), who had no response to first course of induction therapy

30 patients received ADE + GO during induction II and were analyzed. Out of the 30 patients, 11 patients were treated on HDAC arm, and 19 patients were treated on LDAC arm.

→

secondary · POSTED

Overall event-free survival (EFS) was defined as the time from study enrollment to induction failure, relapse, secondary malignancy, death, or study withdrawal for any reason, with event-free patients censored on the date of the last follow-up

238 patients were enrolled on the study. Out of 238, 6 were determined to be ineligible and 2 were not randomized. Of the 230 patients, 14 bi-phenotypic leukemia patients were excluded. 216 AML patients were included to estimate EFS.

→

secondary · POSTED

Inhibition of DNA synthesis is defined as the percentage of DNA synthesis rate at 24-hour post-araC treatment over DNA synthesis rate pre-araC treatment.

Of 232 eligible patients, 49 had DNA synthesis rate performed prior to araC treatment. Of the 49 patients, 23 had no 24-hr samples and 3 did not have enough cells in 24-hr samples. 21 patients with both pre and post araC samples were included in the DNA inhibition study. Of the 21 patients, 9 were treated on HDAC and 12 were treated on LDAC.

→

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-acute-myeloid-leukemia
nct id
NCT00136084
trial label
Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia
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
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia
    nct id
    NCT00136084
    outcome key
    om-0000
    source section id
    NCT00136084-om-0000
    source outcome index
    0
    endpoint
    Minimal Residual Disease (MRD).
    endpoint definition
    Detection of Minimal Residual Disease following one course of chemotherapy where positive MRD was defined as one or more leukemic cell per 1000 mononuclear bone-marrow cells (\>=0.1%).
    time origin
    Day 22 MRD measurement
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Of the 223 randomized patients, 205 patients were included in the day 22 MRD analysis. 18 patients were not included in the day 22 MRD analysis. 5 patients had inadequate sample for MRD, 11 patients had no suitable phenotype to determine MRD, 1 patient was not done on MRD, and 1 patient was lost for follow-up.
    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-acute-myeloid-leukemia
    nct id
    NCT00136084
    outcome key
    om-0001
    source section id
    NCT00136084-om-0001
    source outcome index
    1
    endpoint
    Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO)
    endpoint definition
    To estimate the proportion of minimal residual disease (MRD)+ patients who become MRD- after one course of gemtuzumab ozogamicin (GO)
    time origin
    Consolidation I
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Sixteen patients received GO treatment during consolidation I. One patient with negative MRD received GO treatment, which was not consistent with the protocol definition. 15 patients were analyzed. Out of the 15 patients, 7 patients were treated on HDAC arm and 8 patients were treated on LDAC arm.
    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-acute-myeloid-leukemia
    nct id
    NCT00136084
    outcome key
    om-0002
    source section id
    NCT00136084-om-0002
    source outcome index
    2
    endpoint
    Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO
    endpoint definition
    To estimate proportion of patients with MRD reduction after one course of Induction II (cytarabine + daunomycin + etoposide (ADE) + GO), who had no response to first course of induction therapy.
    time origin
    Induction II
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Out of the 30 patients received ADE + GO treatment, one patient had inevaluable MRD prior to and after the treatment. 29 patients were analyzed. Out of the 29 patients, 10 patients were treated on HDAC arm and 19 patients were treated on LDAC arm.
    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-acute-myeloid-leukemia
    nct id
    NCT00136084
    outcome key
    om-0003
    source section id
    NCT00136084-om-0003
    source outcome index
    3
    endpoint
    Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO.
    endpoint definition
    To estimate proportion of patients experiencing CTC Grade 3 or 4 toxicity during Induction II (Cytarabine + Daunomycin + Etoposide (ADE) + GO), who had no response to first course of induction therapy
    time origin
    Induction II
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    30 patients received ADE + GO during induction II and were analyzed. Out of the 30 patients, 11 patients were treated on HDAC arm, and 19 patients were treated on LDAC arm.
    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-acute-myeloid-leukemia
    nct id
    NCT00136084
    outcome key
    om-0004
    source section id
    NCT00136084-om-0004
    source outcome index
    4
    endpoint
    To Estimate the Overall Event-free Survival (EFS) of AML Patients Who Undergo Risk-adapted and Genotype-directed Therapy
    endpoint definition
    Overall event-free survival (EFS) was defined as the time from study enrollment to induction failure, relapse, secondary malignancy, death, or study withdrawal for any reason, with event-free patients censored on the date of the last follow-up
    time origin
    Five Year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    238 patients were enrolled on the study. Out of 238, 6 were determined to be ineligible and 2 were not randomized. Of the 230 patients, 14 bi-phenotypic leukemia patients were excluded. 216 AML patients were included to estimate EFS.
    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-acute-myeloid-leukemia
    nct id
    NCT00136084
    outcome key
    om-0005
    source section id
    NCT00136084-om-0005
    source outcome index
    5
    endpoint
    To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy
    endpoint definition
    Inhibition of DNA synthesis is defined as the percentage of DNA synthesis rate at 24-hour post-araC treatment over DNA synthesis rate pre-araC treatment.
    time origin
    Measurements were assessed in Induction I chemotherapy
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Of 232 eligible patients, 49 had DNA synthesis rate performed prior to araC treatment. Of the 49 patients, 23 had no 24-hr samples and 3 did not have enough cells in 24-hr samples. 21 patients with both pre and post araC samples were included in the DNA inhibition study. Of the 21 patients, 9 were treated on HDAC and 12 were treated on LDAC.
    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-acute-myeloid-leukemia
    nct id
    NCT00136084
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm 1: (HDAC)
    regimen
    High-dose Cytarabine (HDAC)
    analyzed count
    99
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00136084-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia
    nct id
    NCT00136084
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm 2:(LDAC)
    regimen
    Low-dose Cytarabine (LDAC)
    analyzed count
    106
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00136084-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia
    nct id
    NCT00136084
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Overall
    regimen
    Post-GO Treatment MRD
    analyzed count
    15
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00136084-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia
    nct id
    NCT00136084
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Overall
    regimen
    Patients who have no response to one course of induction therapy
    analyzed count
    29
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00136084-om-0002#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia
    nct id
    NCT00136084
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Overall
    regimen
    Post-GO Treatment MRD
    analyzed count
    30
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00136084-om-0003#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia
    nct id
    NCT00136084
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Overall
    regimen
    Evaluation of all study participants
    analyzed count
    216
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00136084-om-0004#groups/OG000
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia
    nct id
    NCT00136084
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Arm 1: (HDAC)
    regimen
    High-dose Cytarabine (Ara-C) (HDAC)
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00136084-om-0005#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia
    nct id
    NCT00136084
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Arm 2:(LDAC)
    regimen
    Low-dose Cytarabine (Ara-C) (LDAC)
    analyzed count
    12
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00136084-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-myeloid-leukemia
    nct id
    NCT00136084
    harm key
    EG000
    source section id
    NCT00136084-ae
    event group key
    EG000
    event group label
    Arm 1: (HDAC)
    serious affected
    23
    serious at risk
    109
    other affected
    107
    other at risk
    109
    frequency threshold
    5
    collection period
    Adverse events have been collected from study inception (October, 2002) through February, 2009.
    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-acute-myeloid-leukemia
    nct id
    NCT00136084
    harm key
    EG001
    source section id
    NCT00136084-ae
    event group key
    EG001
    event group label
    Arm 2:(LDAC)
    serious affected
    19
    serious at risk
    114
    other affected
    112
    other at risk
    114
    frequency threshold
    5
    collection period
    Adverse events have been collected from study inception (October, 2002) through February, 2009.
    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