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NCT01998035 · BASELINE

Baseline characteristics

Romidepsin Plus Oral 5-Azacitidine in Relapsed/Refractory Lymphoid Malignancies · Source last updated 2024-08-22

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
      33
    2. group Id
      BG001
      value
      25
    3. group Id
      BG002
      value
      58
    units
    Participants
groups
  1. description
    Phase 1 is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romidepsin in patients with lymphoma. Patients will be administered the study drugs in a 3 + 3 dose-escalation study.
    id
    BG000
    title
    Phase 1
  2. description
    Patients will be treated with oral 5-azacytidine and Romidepsin at the MTD. The treatment will be administered as follows: oral 5-azacytidine 300 mg (flat dose) on Days 1-14 and Romidepsin 14 mg/m2 (flat dose) on Days 8, 15, and 22 on a 35-day cycle.
    id
    BG001
    title
    Phase 2
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          23
          upper Limit
          79
          value
          57
        2. group Id
          BG001
          lower Limit
          42
          upper Limit
          88
          value
          63
        3. comment
          The median age for the entire study was not calculated at the time of data analysis. The standard deviation cannot be calculated without the raw data. The raw data cannot be accessed, as the Principal Investigator and entire study team has left the institution. In addition, the study closed with the Institutional Review Board in 2021 and further analysis cannot be conducted.
          group Id
          BG002
          lower Limit
          23
          upper Limit
          88
          value
          NA
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          22
      title
      Female
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          34
      title
      Male
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex/Gender, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          13
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          42
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          47
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Baseline characteristics and study results were only collected as the combined total from participants per study phase. Baseline characteristics were not collected per dose level and thus cannot be reported per dose level. Baseline characteristics were collected from all participants who enrolled/consented in Phase 1 (n=33) and Phase 2 (n=25). Of those 33 enrolled in Phase 1, 26 received the study interventions and only those 26 are counted in the Participant Flow.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      33
    2. group Id
      BG001
      value
      25
    3. group Id
      BG002
      value
      58
    units
    Participants
groups
  1. description
    Phase 1 is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romidepsin in patients with lymphoma. Patients will be administered the study drugs in a 3 + 3 dose-escalation study.
    id
    BG000
    title
    Phase 1
  2. description
    Patients will be treated with oral 5-azacytidine and Romidepsin at the MTD. The treatment will be administered as follows: oral 5-azacytidine 300 mg (flat dose) on Days 1-14 and Romidepsin 14 mg/m2 (flat dose) on Days 8, 15, and 22 on a 35-day cycle.
    id
    BG001
    title
    Phase 2
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          23
          upper Limit
          79
          value
          57
        2. group Id
          BG001
          lower Limit
          42
          upper Limit
          88
          value
          63
        3. comment
          The median age for the entire study was not calculated at the time of data analysis. The standard deviation cannot be calculated without the raw data. The raw data cannot be accessed, as the Principal Investigator and entire study team has left the institution. In addition, the study closed with the Institutional Review Board in 2021 and further analysis cannot be conducted.
          group Id
          BG002
          lower Limit
          23
          upper Limit
          88
          value
          NA
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          22
      title
      Female
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          34
      title
      Male
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex/Gender, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          13
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          42
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          47
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Baseline characteristics and study results were only collected as the combined total from participants per study phase. Baseline characteristics were not collected per dose level and thus cannot be reported per dose level. Baseline characteristics were collected from all participants who enrolled/consented in Phase 1 (n=33) and Phase 2 (n=25). Of those 33 enrolled in Phase 1, 26 received the study interventions and only those 26 are counted in the Participant Flow.

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

Preserved source evidence · Not medical advice