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NCT00109707 · STUDY IN CONTEXT

A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

Major Cytogenetic Response (MCyR) is defined as Complete Cytogenetic Response (CCyR: 0% Ph-chromosome-positive cells in metaphase in bone marrow) or Partial Cytogenetic Response (PCyR: 1-35% Ph-chromosome-positive cells in metaphase in bone marrow).

Full Analysis Set (FAS): All participants who received at least one dose of study medication

→

primary · POSTED

Hematologic response is defined as the percentage of participants in complete hematologic response (defined as the following present for at least 4 weeks: WBC count \<10 x 109/L, Platelet count \<450 x 109/L, Basophils \<5%, No blasts and promyelocytes in peripheral blood, Myelocytes + metamyelocytes \< 5% in peripheral blood, No evidence of extramedullary disease, including spleen and liver). Hematological response was a primary outcome measure for Arm CML-AP with prior imatinib only.

Full Analysis Set (FAS): All participants who received at least one dose of study medication.

→

secondary · POSTED

Cytogenetic responses (CyRs) in CML are based on the percentage of Ph+ metaphases in bone marrow; a value of 0% Ph+ metaphases defines a complete cytogenetic response (CCyR) and \>0% to 35% defines a major cytogenetic response (MCyR). Achievement of CCyR is associated with a significant survival advantage in participants with CML-CP. MCyR was categorized as either CCyR or partial cytogenetic response (PCyR).

Full Analysis Set (FAS): All participants who received at least one dose of study medication

→

secondary · POSTED

A Complete Hematologic Response (CHR) is obtained when all the following criteria are met: WBC ≤ institutional ULN; platelets ≤ 450,000/mm3; ≤20% basophils in peripheral blood; no blasts or promyelocytes in PB cells; \< 5% myelocytes plus metamyelocytes in PB cells; no extra-medullary involvement including no hepatomegaly or splenomegaly.

Full Analysis Set (FAS): All participants who received at least one dose of study medication

→

secondary · POSTED

MMR was defined for participants who demonstrated a reduction in BCR-ABL/control gene % transcripts to ≤0.1% based on international scale. The control gene used may have been either BCR or ABL.

Full Analysis Set (FAS): All participants who received at least one dose of study medication. Major molecular response was not an efficacy variable for participants who received the CML-CP with prior imatinib and other TKI (Group B E8)

→

secondary · POSTED

Time to Progression was defined as the time from the start of nilotinib to the earliest date of Disease Progression (PD), discontinuation due to PD or death. Disease progression was defined as an increase in the number of circulating leukemic cells via cytogenetic assessment using real-time quantitative reverse transcriptase polymerase chain reaction (PCR).

Full Analysis Set (FAS): All participants who received at least one dose of study medication. Time to progression was not an efficacy variable for participants who received the CML-CP with prior imatinib and other TKI (Group B E8).

→

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-lymphoblastic-leukemia-arranon-a85b0386
nct id
NCT00109707
trial label
A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies
applicability
unclear
applicability note
Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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
3
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00109707
    outcome key
    om-0000
    source section id
    NCT00109707-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Major Cytogenetic Response (MCyR)
    endpoint definition
    Major Cytogenetic Response (MCyR) is defined as Complete Cytogenetic Response (CCyR: 0% Ph-chromosome-positive cells in metaphase in bone marrow) or Partial Cytogenetic Response (PCyR: 1-35% Ph-chromosome-positive cells in metaphase in bone marrow).
    time origin
    Up to End of the Treatment (Approximately 7.5 years)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set (FAS): All participants who received at least one dose of study medication
    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-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00109707
    outcome key
    om-0001
    source section id
    NCT00109707-om-0001
    source outcome index
    1
    endpoint
    Number of Participants Confirmed Overall Hematological Response (Phase II)
    endpoint definition
    Hematologic response is defined as the percentage of participants in complete hematologic response (defined as the following present for at least 4 weeks: WBC count \<10 x 109/L, Platelet count \<450 x 109/L, Basophils \<5%, No blasts and promyelocytes in peripheral blood, Myelocytes + metamyelocytes \< 5% in peripheral blood, No evidence of extramedullary disease, including spleen and liver). Hematological response was a primary outcome measure for Arm CML-AP with prior imatinib only.
    time origin
    Up to End of the Treatment (Approximately 7.5 years)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set (FAS): All participants who received at least one dose of study medication.
    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-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00109707
    outcome key
    om-0002
    source section id
    NCT00109707-om-0002
    source outcome index
    2
    endpoint
    Number of Participants With Overall Major Cytogenetic Responses (Phase II)
    endpoint definition
    Cytogenetic responses (CyRs) in CML are based on the percentage of Ph+ metaphases in bone marrow; a value of 0% Ph+ metaphases defines a complete cytogenetic response (CCyR) and \>0% to 35% defines a major cytogenetic response (MCyR). Achievement of CCyR is associated with a significant survival advantage in participants with CML-CP. MCyR was categorized as either CCyR or partial cytogenetic response (PCyR).
    time origin
    Up to End of the Treatment (Approximately 7.5 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set (FAS): All participants who received at least one dose of study medication
    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-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00109707
    outcome key
    om-0003
    source section id
    NCT00109707-om-0003
    source outcome index
    3
    endpoint
    Number of Participants With Complete Hematologic Response (Phase II)
    endpoint definition
    A Complete Hematologic Response (CHR) is obtained when all the following criteria are met: WBC ≤ institutional ULN; platelets ≤ 450,000/mm3; ≤20% basophils in peripheral blood; no blasts or promyelocytes in PB cells; \< 5% myelocytes plus metamyelocytes in PB cells; no extra-medullary involvement including no hepatomegaly or splenomegaly.
    time origin
    Up to End of the Treatment (Approximately 7.5 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set (FAS): All participants who received at least one dose of study medication
    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-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00109707
    outcome key
    om-0004
    source section id
    NCT00109707-om-0004
    source outcome index
    4
    endpoint
    Participants With (MMR) Major Molecular Response (Phase II)
    endpoint definition
    MMR was defined for participants who demonstrated a reduction in BCR-ABL/control gene % transcripts to ≤0.1% based on international scale. The control gene used may have been either BCR or ABL.
    time origin
    Up to End of the Treatment (Approximately 7.5 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set (FAS): All participants who received at least one dose of study medication. Major molecular response was not an efficacy variable for participants who received the CML-CP with prior imatinib and other TKI (Group B E8)
    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-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00109707
    outcome key
    om-0005
    source section id
    NCT00109707-om-0005
    source outcome index
    5
    endpoint
    Time to Progression (TTP) (Phase II)
    endpoint definition
    Time to Progression was defined as the time from the start of nilotinib to the earliest date of Disease Progression (PD), discontinuation due to PD or death. Disease progression was defined as an increase in the number of circulating leukemic cells via cytogenetic assessment using real-time quantitative reverse transcriptase polymerase chain reaction (PCR).
    time origin
    Up to End of the Treatment (Approximately 7.5 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set (FAS): All participants who received at least one dose of study medication. Time to progression was not an efficacy variable for participants who received the CML-CP with prior imatinib and other TKI (Group B E8).
    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-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00109707
    outcome key
    om-0000
    arm key
    OG000
    arm label
    CML-CP With Prior Imatinib Only
    regimen
    Adult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
    analyzed count
    321
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00109707-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00109707
    outcome key
    om-0000
    arm key
    OG001
    arm label
    CML-AP With Prior Imatinib Only
    regimen
    Adult participants PH+ CML-AP (Accelerated Phase Chronic Myeloid Leukemia) without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
    analyzed count
    137
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00109707-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00109707
    outcome key
    om-0000
    arm key
    OG002
    arm label
    CML-CP
    regimen
    Adult participants Ph+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
    analyzed count
    49
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00109707-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00109707
    outcome key
    om-0001
    arm key
    OG000
    arm label
    CML-AP With Prior Imatinib Only
    regimen
    Adult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
    analyzed count
    137
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00109707-om-0001#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00109707
    outcome key
    om-0002
    arm key
    OG000
    arm label
    CML-CP With Prior Imatinib Only
    regimen
    Adult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
    analyzed count
    321
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00109707-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00109707
    outcome key
    om-0002
    arm key
    OG001
    arm label
    CML-AP With Prior Imatinib Only
    regimen
    Adult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
    analyzed count
    137
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00109707-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00109707
    outcome key
    om-0002
    arm key
    OG002
    arm label
    CML-CP
    regimen
    Adult participants Ph+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
    analyzed count
    49
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00109707-om-0002#groups/OG002
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00109707
    outcome key
    om-0003
    arm key
    OG000
    arm label
    CML-CP With Prior Imatinib Only
    regimen
    Adult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
    analyzed count
    321
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00109707-om-0003#groups/OG000
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00109707
    outcome key
    om-0003
    arm key
    OG001
    arm label
    CML-AP With Prior Imatinib Only
    regimen
    Adult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
    analyzed count
    137
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00109707-om-0003#groups/OG001
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00109707
    outcome key
    om-0003
    arm key
    OG002
    arm label
    CML-CP
    regimen
    Adult participants Ph+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
    analyzed count
    35
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00109707-om-0003#groups/OG002
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00109707
    outcome key
    om-0004
    arm key
    OG000
    arm label
    CML-CP With Prior Imatinib Only
    regimen
    Adult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
    analyzed count
    299
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00109707-om-0004#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00109707
    outcome key
    om-0004
    arm key
    OG001
    arm label
    CML-AP With Prior Imatinib Only
    regimen
    Adult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
    analyzed count
    122
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00109707-om-0004#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00109707
    harm key
    EG000
    source section id
    NCT00109707-ae
    event group key
    EG000
    event group label
    CML-CP With Prior Imatinib Only
    serious affected
    146
    serious at risk
    321
    other affected
    319
    other at risk
    321
    frequency threshold
    5
    collection period
    From First Participant First Visit to Last Participant Last Visit (Approximately 7.5 years)
    event definition
    Safety set: All participants who received at least one dose of study medication and had at least one post baseline safety assessment.
    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-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00109707
    harm key
    EG001
    source section id
    NCT00109707-ae
    event group key
    EG001
    event group label
    CML-AP With Prior Imatinib Only
    serious affected
    55
    serious at risk
    137
    other affected
    136
    other at risk
    137
    frequency threshold
    5
    collection period
    From First Participant First Visit to Last Participant Last Visit (Approximately 7.5 years)
    event definition
    Safety set: All participants who received at least one dose of study medication and had at least one post baseline safety assessment.
    undenominated 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-acute-lymphoblastic-leukemia-arranon-a85b0386
    nct id
    NCT00109707
    harm key
    EG002
    source section id
    NCT00109707-ae
    event group key
    EG002
    event group label
    CML-CP
    serious affected
    21
    serious at risk
    49
    other affected
    48
    other at risk
    49
    frequency threshold
    5
    collection period
    From First Participant First Visit to Last Participant Last Visit (Approximately 7.5 years)
    event definition
    Safety set: All participants who received at least one dose of study medication and had at least one post baseline safety assessment.
    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