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NCT02907359 · FLOW

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Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs · 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 received Guadecitabine 60 milligrams per square meter (mg/m\^2), subcutaneously (SC), on Days 1-5 of each 28-day cycle for at least 6 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Participants received Guadecitabine treatment beyond 6 cycles as long as the participant continued to benefit based on investigator judgment and participant response and tolerability (or up to a maximum of 36 cycles).
    id
    FG000
    title
    Guadecitabine
  2. description
    Participants received one of the three treatment choice options: 1. Low dose cytarabine (LDAC) 20 mg/m\^2 SC or intravenous (IV) once daily for 14 days of each 28-day cycles for at least 4 cycles in the absence of disease progression or unacceptable toxicity. Participants who were responding or had stable disease were to continue treatment as per standard and institutional practice. 2. Standard Intensive Chemotherapy (IC) of a 7+3 regimen: Cytarabine 100-200 mg/m\^2/day given as continuous infusion for 7 days and an anthracycline (daunorubicin (45-60 mg)/idarubicin (9-12 mg)/mitoxantrone (8-12 mg)/m\^2) by IV infusion for 3 days of each 28-day cycles. 3. Best Supportive Care (BSC) as needed during the treatment included, but was not limited to, blood transfusions (Red blood cells \[RBCs\] or platelets), growth factors including erythropoiesis stimulating agents, granulocyte stimulating factors, iron chelating therapy, and broad-spectrum antibiotics and/or antifungals. Duration for treatment choice was as per locally approved prescribing information and institutional standard practice or up to a maximum 30 cycles.
    id
    FG001
    title
    Treatment Choice
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        234
      2. group Id
        FG001
        num Subjects
        117
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        11
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        277
      2. group Id
        FG001
        num Subjects
        140
      comment
      The Efficacy Analysis Set included all participants randomly assigned to the study treatment.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        270
      2. group Id
        FG001
        num Subjects
        122
      comment
      The Safety Analysis Set included all participants randomly assigned to study treatment who received any amount of study treatment or any component of a multi-dose study treatment regimen.
      type
      Safety Analysis Set
    3. achievements
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        12
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        241
      2. group Id
        FG001
        num Subjects
        128
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 417 participants were randomized (277 in Guadecitabine arm group and 140 in Treatment Choice arm group) and 392 received treatment. Of 417 participants, 48 completed the study.
recruitment Details
Participants took part in the study at 101 investigative sites in the United States, Canada, Spain, Italy, France, Germany, Czech Republic, Denmark, Poland, Belgium, Sweden, United Kingdom, Japan, and South Korea from 13 January 2017 to 30 November 2020.
Complete source fields
groups
  1. description
    Participants received Guadecitabine 60 milligrams per square meter (mg/m\^2), subcutaneously (SC), on Days 1-5 of each 28-day cycle for at least 6 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Participants received Guadecitabine treatment beyond 6 cycles as long as the participant continued to benefit based on investigator judgment and participant response and tolerability (or up to a maximum of 36 cycles).
    id
    FG000
    title
    Guadecitabine
  2. description
    Participants received one of the three treatment choice options: 1. Low dose cytarabine (LDAC) 20 mg/m\^2 SC or intravenous (IV) once daily for 14 days of each 28-day cycles for at least 4 cycles in the absence of disease progression or unacceptable toxicity. Participants who were responding or had stable disease were to continue treatment as per standard and institutional practice. 2. Standard Intensive Chemotherapy (IC) of a 7+3 regimen: Cytarabine 100-200 mg/m\^2/day given as continuous infusion for 7 days and an anthracycline (daunorubicin (45-60 mg)/idarubicin (9-12 mg)/mitoxantrone (8-12 mg)/m\^2) by IV infusion for 3 days of each 28-day cycles. 3. Best Supportive Care (BSC) as needed during the treatment included, but was not limited to, blood transfusions (Red blood cells \[RBCs\] or platelets), growth factors including erythropoiesis stimulating agents, granulocyte stimulating factors, iron chelating therapy, and broad-spectrum antibiotics and/or antifungals. Duration for treatment choice was as per locally approved prescribing information and institutional standard practice or up to a maximum 30 cycles.
    id
    FG001
    title
    Treatment Choice
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        234
      2. group Id
        FG001
        num Subjects
        117
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        11
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        277
      2. group Id
        FG001
        num Subjects
        140
      comment
      The Efficacy Analysis Set included all participants randomly assigned to the study treatment.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        270
      2. group Id
        FG001
        num Subjects
        122
      comment
      The Safety Analysis Set included all participants randomly assigned to study treatment who received any amount of study treatment or any component of a multi-dose study treatment regimen.
      type
      Safety Analysis Set
    3. achievements
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        12
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        241
      2. group Id
        FG001
        num Subjects
        128
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 417 participants were randomized (277 in Guadecitabine arm group and 140 in Treatment Choice arm group) and 392 received treatment. Of 417 participants, 48 completed the study.
recruitment Details
Participants took part in the study at 101 investigative sites in the United States, Canada, Spain, Italy, France, Germany, Czech Republic, Denmark, Poland, Belgium, Sweden, United Kingdom, Japan, and South Korea from 13 January 2017 to 30 November 2020.

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Preserved source evidence · Not medical advice