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NCT03306264 · FLOW

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Study of ASTX727 vs IV Decitabine in Participants With MDS, CMML, and AML · Source last updated 2024-08-27

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

groups
  1. description
    Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
    id
    FG000
    title
    MDS or CMML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727
  2. description
    Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
    id
    FG001
    title
    MDS or CMML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727
  3. description
    Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
    id
    FG002
    title
    AML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727
  4. description
    Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
    id
    FG003
    title
    AML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        33
      2. group Id
        FG001
        num Subjects
        25
      3. group Id
        FG002
        num Subjects
        34
      4. group Id
        FG003
        num Subjects
        34
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        8
      type
      Complete Consent Withdrawal
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        2
      type
      Rollover to ASTX727-06
    5. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        22
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        1
      type
      Study Centre Terminated by Sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        69
      3. group Id
        FG002
        num Subjects
        44
      4. group Id
        FG003
        num Subjects
        45
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        67
      3. group Id
        FG002
        num Subjects
        43
      4. group Id
        FG003
        num Subjects
        44
      comment
      The Safety Analysis Set included all participants who received any amount of study treatment.
      type
      Safety Analysis Set
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        69
      3. group Id
        FG002
        num Subjects
        44
      4. group Id
        FG003
        num Subjects
        45
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 138 participants with a diagnosis of MDS or CMML were enrolled and randomized in a 1:1 ratio to receive ASTX727 or decitabine in a crossover manner. A total of 89 participants with a diagnosis of AML were enrolled and randomized in a 1:1 ratio to receive ASTX727 or decitabine in a crossover manner.
recruitment Details
A total of 227 participants took part in the study from 15 February 2018 to 25 May 2023. 138 participants with a diagnosis of myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) took part from the United States and Canada. 89 participants with a diagnosis of acute myeloid leukemia (AML) took part from Austria, Canada, Czech Republic, France, Germany, Hungary, Italy, Spain, and United Kingdom.
Complete source fields
groups
  1. description
    Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
    id
    FG000
    title
    MDS or CMML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727
  2. description
    Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
    id
    FG001
    title
    MDS or CMML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727
  3. description
    Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
    id
    FG002
    title
    AML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727
  4. description
    Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
    id
    FG003
    title
    AML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        33
      2. group Id
        FG001
        num Subjects
        25
      3. group Id
        FG002
        num Subjects
        34
      4. group Id
        FG003
        num Subjects
        34
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        8
      type
      Complete Consent Withdrawal
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        2
      type
      Rollover to ASTX727-06
    5. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        22
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        1
      type
      Study Centre Terminated by Sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        69
      3. group Id
        FG002
        num Subjects
        44
      4. group Id
        FG003
        num Subjects
        45
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        67
      3. group Id
        FG002
        num Subjects
        43
      4. group Id
        FG003
        num Subjects
        44
      comment
      The Safety Analysis Set included all participants who received any amount of study treatment.
      type
      Safety Analysis Set
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        69
      3. group Id
        FG002
        num Subjects
        44
      4. group Id
        FG003
        num Subjects
        45
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 138 participants with a diagnosis of MDS or CMML were enrolled and randomized in a 1:1 ratio to receive ASTX727 or decitabine in a crossover manner. A total of 89 participants with a diagnosis of AML were enrolled and randomized in a 1:1 ratio to receive ASTX727 or decitabine in a crossover manner.
recruitment Details
A total of 227 participants took part in the study from 15 February 2018 to 25 May 2023. 138 participants with a diagnosis of myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) took part from the United States and Canada. 89 participants with a diagnosis of acute myeloid leukemia (AML) took part from Austria, Canada, Czech Republic, France, Germany, Hungary, Italy, Spain, and United Kingdom.

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Preserved source evidence · Not medical advice