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NCT02684162 · BASELINE

Baseline characteristics

Guadecitabine and Donor Lymphocyte Infusion in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Relapsing After Allogeneic Stem Cell Transplant · Source last updated 2025-11-06

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

denoms
  1. counts
    1. group Id
      BG000
      value
      13
    2. group Id
      BG001
      value
      18
    3. group Id
      BG002
      value
      24
    4. group Id
      BG003
      value
      55
    units
    Participants
groups
  1. description
    Patients with morphological relapse for AML and MDS at least 90 days post-transplant. MDS patients: Re-appearance of dysplastic changes in the bone marrow, with or without increase in bone marrow blast count, which is pathologically consistent with myelodysplastic syndrome. AML patients: Bone marrow blast count \>/= 5%.
    id
    BG000
    title
    Cohort 1: Relapsed Leukemia Post-transplant
  2. description
    Cohort 2: Persistence or reappearance of minimal residual disease by flow cytometry or cytogenetic or molecular testing while being in morphological remission after allogeneic stem cell transplantation.
    id
    BG001
    title
    Cohort 2: MRD(Minimal Residual Disease) Post-transplant
  3. description
    Cohort 3: High risk AML and MDS patients who are in complete remission morphologically with no evidence of minimal residual disease by flow cytometry or cytogenetic or molecular testing after allogeneic stem cell transplantation.
    id
    BG002
    title
    Cohort 3: Maintenance Treatment Post-transplant
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          31
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          24
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          27
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          28
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          7
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          48
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          55
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      13
    2. group Id
      BG001
      value
      18
    3. group Id
      BG002
      value
      24
    4. group Id
      BG003
      value
      55
    units
    Participants
groups
  1. description
    Patients with morphological relapse for AML and MDS at least 90 days post-transplant. MDS patients: Re-appearance of dysplastic changes in the bone marrow, with or without increase in bone marrow blast count, which is pathologically consistent with myelodysplastic syndrome. AML patients: Bone marrow blast count \>/= 5%.
    id
    BG000
    title
    Cohort 1: Relapsed Leukemia Post-transplant
  2. description
    Cohort 2: Persistence or reappearance of minimal residual disease by flow cytometry or cytogenetic or molecular testing while being in morphological remission after allogeneic stem cell transplantation.
    id
    BG001
    title
    Cohort 2: MRD(Minimal Residual Disease) Post-transplant
  3. description
    Cohort 3: High risk AML and MDS patients who are in complete remission morphologically with no evidence of minimal residual disease by flow cytometry or cytogenetic or molecular testing after allogeneic stem cell transplantation.
    id
    BG002
    title
    Cohort 3: Maintenance Treatment Post-transplant
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          31
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          24
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          27
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          28
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          7
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          48
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          55
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice