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NCT00471497 · FLOW

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A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) · Source last updated 2020-11-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated
    id
    FG000
    title
    Imatinib 400 mg QD
  2. description
    Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
    id
    FG001
    title
    Nilotinb 300 mg BID
  3. description
    Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
    id
    FG002
    title
    Nilotinib 400 mg BID
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        9
      type
      Abnormal Laboratory Values
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Abnormal Test Procedures
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Condition no longer requires study drug
    4. reasons
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        29
      3. group Id
        FG002
        num Subjects
        34
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        3
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        3
      type
      Death
    7. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      type
      Disease Progression
    8. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        11
      type
      Protocol Violation
    9. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        13
      type
      Sub optimal response or treat. failure
    10. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        12
      type
      Administrative problems
    11. reasons
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        53
      3. group Id
        FG002
        num Subjects
        89
      type
      Adverse Event
    12. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Disc. Core/Entered Ext. - DP progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        283
      2. group Id
        FG001
        num Subjects
        282
      3. group Id
        FG002
        num Subjects
        281
      type
      STARTED
    2. achievements
      1. comment
        Safety set contained patients who received at least one dose of study medication.
        group Id
        FG000
        num Subjects
        280
      2. comment
        Safety set contained patients who received at least one dose of study medication.
        group Id
        FG001
        num Subjects
        279
      3. comment
        Safety set contained patients who received at least one dose of study medication.
        group Id
        FG002
        num Subjects
        277
      type
      Safety Analysis Set
    3. achievements
      1. group Id
        FG000
        num Subjects
        235
      2. group Id
        FG001
        num Subjects
        256
      3. group Id
        FG002
        num Subjects
        278
      type
      Discon. Core/Did Not Enter Ext.
    4. achievements
      1. group Id
        FG000
        num Subjects
        48
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        3
      type
      Discontinued Core/Entered Ext.
    5. achievements
      1. group Id
        FG000
        num Subjects
        99
      2. group Id
        FG001
        num Subjects
        107
      3. group Id
        FG002
        num Subjects
        99
      comment
      Completed = Completed Core phase as per protocol
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        184
      2. group Id
        FG001
        num Subjects
        175
      3. group Id
        FG002
        num Subjects
        182
      type
      NOT COMPLETED
    title
    Core Treatment Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      type
      Unsatisfactory therapeutic effect
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease progression
    7. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        48
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        2
      comment
      Completed = Completed Ext. phase as per protocol
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Extension Phase
pre Assignment Details
Randomization was planned for a total of 771 patients.
recruitment Details
The study over-enrolled, and 846 patients (283 in the imatinib 400 mg arm, 282 in the nilotinib 300 mg arm and 281 in the nilotinib 400 mg arm) were randomized. DP = disease progression, SOR/TF = Suboptimal response or treatment failure
Complete source fields
groups
  1. description
    Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated
    id
    FG000
    title
    Imatinib 400 mg QD
  2. description
    Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
    id
    FG001
    title
    Nilotinb 300 mg BID
  3. description
    Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
    id
    FG002
    title
    Nilotinib 400 mg BID
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        9
      type
      Abnormal Laboratory Values
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Abnormal Test Procedures
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Condition no longer requires study drug
    4. reasons
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        29
      3. group Id
        FG002
        num Subjects
        34
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        3
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        3
      type
      Death
    7. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      type
      Disease Progression
    8. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        11
      type
      Protocol Violation
    9. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        13
      type
      Sub optimal response or treat. failure
    10. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        12
      type
      Administrative problems
    11. reasons
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        53
      3. group Id
        FG002
        num Subjects
        89
      type
      Adverse Event
    12. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Disc. Core/Entered Ext. - DP progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        283
      2. group Id
        FG001
        num Subjects
        282
      3. group Id
        FG002
        num Subjects
        281
      type
      STARTED
    2. achievements
      1. comment
        Safety set contained patients who received at least one dose of study medication.
        group Id
        FG000
        num Subjects
        280
      2. comment
        Safety set contained patients who received at least one dose of study medication.
        group Id
        FG001
        num Subjects
        279
      3. comment
        Safety set contained patients who received at least one dose of study medication.
        group Id
        FG002
        num Subjects
        277
      type
      Safety Analysis Set
    3. achievements
      1. group Id
        FG000
        num Subjects
        235
      2. group Id
        FG001
        num Subjects
        256
      3. group Id
        FG002
        num Subjects
        278
      type
      Discon. Core/Did Not Enter Ext.
    4. achievements
      1. group Id
        FG000
        num Subjects
        48
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        3
      type
      Discontinued Core/Entered Ext.
    5. achievements
      1. group Id
        FG000
        num Subjects
        99
      2. group Id
        FG001
        num Subjects
        107
      3. group Id
        FG002
        num Subjects
        99
      comment
      Completed = Completed Core phase as per protocol
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        184
      2. group Id
        FG001
        num Subjects
        175
      3. group Id
        FG002
        num Subjects
        182
      type
      NOT COMPLETED
    title
    Core Treatment Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      type
      Unsatisfactory therapeutic effect
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease progression
    7. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        48
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        2
      comment
      Completed = Completed Ext. phase as per protocol
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Extension Phase
pre Assignment Details
Randomization was planned for a total of 771 patients.
recruitment Details
The study over-enrolled, and 846 patients (283 in the imatinib 400 mg arm, 282 in the nilotinib 300 mg arm and 281 in the nilotinib 400 mg arm) were randomized. DP = disease progression, SOR/TF = Suboptimal response or treatment failure

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