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NCT01947140 · BASELINE

Baseline characteristics

Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies · Source last updated 2026-09-16

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
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      3
    6. group Id
      BG005
      value
      5
    7. group Id
      BG006
      value
      3
    8. group Id
      BG007
      value
      6
    9. group Id
      BG008
      value
      18
    10. group Id
      BG009
      value
      47
    units
    Participants
groups
  1. description
    Cohort 1, Dose Level -1 Subjects will be administered through IV: Pralatrexate 10 mg/m2 on days 1 and 8 of each 21 day cycle. Romidepsin 12 mg/m2 on days 1 and 8 of each 21 day cycle.
    id
    BG000
    title
    Pralatrexate 10 mg/m2, Romidepsin 12 mg/m2
  2. description
    Cohort 2A, Dose Level 1 Subjects will be administered through IV: Pralatrexate 15 mg/m2 on days 1 and 8 of each 21 day cycle. Romidepsin 12 mg/m2 on days 1 and 8 of each 21 day cycle.
    id
    BG001
    title
    Phase 1 Schedule A: Pralatrexate 15 mg/m2, Romidepsin 12 mg/m2
  3. description
    Cohort 2B, Dose Level 1 Subjects will be administered through IV: Pralatrexate 15 mg/m2 on days 1 and 15 of each 28 day cycle. Romidepsin 12 mg/m2 on days 1 and 15 of each 28 day cycle.
    id
    BG002
    title
    Phase 1 Schedule B: Pralatrexate 15 mg/m2, Romidepsin 12 mg/m2
  4. description
    Cohort 3A, Dose Level 2 Subjects will be administered through IV: Pralatrexate 15 mg/m2 on days 1 and 8 of each 21 day cycle. Romidepsin 14 mg/m2 on days 1 and 8 of each 21 day cycle.
    id
    BG003
    title
    Phase 1 Schedule A: Pralatrexate 15 mg/m2, Romidepsin 14 mg/m2
  5. description
    Cohort 3B, Dose Level 2 Subjects will be administered through IV: Pralatrexate 15 mg/m2 on days 1 and 15 of each 28 day cycle. Romidepsin 14 mg/m2 on days 1 and 15 of each 28 day cycle.
    id
    BG004
    title
    Phase 1 Schedule B: Pralatrexate 15 mg/m2, Romidepsin 14 mg/m2
  6. description
    Cohort 4A, Dose Level 3 Subjects will be administered through IV: Pralatrexate 20 mg/m2 on days 1 and 8 of each 21 day cycle. Romidepsin 12 mg/m2 on days 1 and 8 of each 21 day cycle.
    id
    BG005
    title
    Phase 1 Schedule A: Pralatrexate 20 mg/m2, Romidepsin 12 mg/m2
  7. description
    Cohort 4B, Dose Level 3 Subjects will be administered through IV: Pralatrexate 20 mg/m2 on days 1 and 15 of each 28 day cycle. Romidepsin 12 mg/m2 on days 1 and 15 of each 28 day cycle.
    id
    BG006
    title
    Phase 1 Schedule B: Pralatrexate 20 mg/m2, Romidepsin 12 mg/m2
  8. description
    Cohort 5B, Dose Level 4 Subjects will be administered through IV: Pralatrexate 25 mg/m2 on days 1 and 15 of each 28 day cycle. Romidepsin 12 mg/m2 on days 1 and 15 of each 28 day cycle.
    id
    BG007
    title
    Phase 1 Schedule B: Pralatrexate 25 mg/m2, Romidepsin 12 mg/m2
  9. description
    Subjects will receive Pralatrexate 25 mg/m2 and Romidepsin 12 mg/m2 will be given intravenously once weekly on days 1 and 15 on a 28-day cycle.
    id
    BG008
    title
    Phase 2
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          18
        10. group Id
          BG009
          value
          47
      title
      > 18 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          17
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          30
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          9
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          14
        10. group Id
          BG009
          value
          35
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          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
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          10
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          14
        10. group Id
          BG009
          value
          31
        title
        White
      6. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      3
    6. group Id
      BG005
      value
      5
    7. group Id
      BG006
      value
      3
    8. group Id
      BG007
      value
      6
    9. group Id
      BG008
      value
      18
    10. group Id
      BG009
      value
      47
    units
    Participants
groups
  1. description
    Cohort 1, Dose Level -1 Subjects will be administered through IV: Pralatrexate 10 mg/m2 on days 1 and 8 of each 21 day cycle. Romidepsin 12 mg/m2 on days 1 and 8 of each 21 day cycle.
    id
    BG000
    title
    Pralatrexate 10 mg/m2, Romidepsin 12 mg/m2
  2. description
    Cohort 2A, Dose Level 1 Subjects will be administered through IV: Pralatrexate 15 mg/m2 on days 1 and 8 of each 21 day cycle. Romidepsin 12 mg/m2 on days 1 and 8 of each 21 day cycle.
    id
    BG001
    title
    Phase 1 Schedule A: Pralatrexate 15 mg/m2, Romidepsin 12 mg/m2
  3. description
    Cohort 2B, Dose Level 1 Subjects will be administered through IV: Pralatrexate 15 mg/m2 on days 1 and 15 of each 28 day cycle. Romidepsin 12 mg/m2 on days 1 and 15 of each 28 day cycle.
    id
    BG002
    title
    Phase 1 Schedule B: Pralatrexate 15 mg/m2, Romidepsin 12 mg/m2
  4. description
    Cohort 3A, Dose Level 2 Subjects will be administered through IV: Pralatrexate 15 mg/m2 on days 1 and 8 of each 21 day cycle. Romidepsin 14 mg/m2 on days 1 and 8 of each 21 day cycle.
    id
    BG003
    title
    Phase 1 Schedule A: Pralatrexate 15 mg/m2, Romidepsin 14 mg/m2
  5. description
    Cohort 3B, Dose Level 2 Subjects will be administered through IV: Pralatrexate 15 mg/m2 on days 1 and 15 of each 28 day cycle. Romidepsin 14 mg/m2 on days 1 and 15 of each 28 day cycle.
    id
    BG004
    title
    Phase 1 Schedule B: Pralatrexate 15 mg/m2, Romidepsin 14 mg/m2
  6. description
    Cohort 4A, Dose Level 3 Subjects will be administered through IV: Pralatrexate 20 mg/m2 on days 1 and 8 of each 21 day cycle. Romidepsin 12 mg/m2 on days 1 and 8 of each 21 day cycle.
    id
    BG005
    title
    Phase 1 Schedule A: Pralatrexate 20 mg/m2, Romidepsin 12 mg/m2
  7. description
    Cohort 4B, Dose Level 3 Subjects will be administered through IV: Pralatrexate 20 mg/m2 on days 1 and 15 of each 28 day cycle. Romidepsin 12 mg/m2 on days 1 and 15 of each 28 day cycle.
    id
    BG006
    title
    Phase 1 Schedule B: Pralatrexate 20 mg/m2, Romidepsin 12 mg/m2
  8. description
    Cohort 5B, Dose Level 4 Subjects will be administered through IV: Pralatrexate 25 mg/m2 on days 1 and 15 of each 28 day cycle. Romidepsin 12 mg/m2 on days 1 and 15 of each 28 day cycle.
    id
    BG007
    title
    Phase 1 Schedule B: Pralatrexate 25 mg/m2, Romidepsin 12 mg/m2
  9. description
    Subjects will receive Pralatrexate 25 mg/m2 and Romidepsin 12 mg/m2 will be given intravenously once weekly on days 1 and 15 on a 28-day cycle.
    id
    BG008
    title
    Phase 2
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          18
        10. group Id
          BG009
          value
          47
      title
      > 18 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          17
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          30
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          9
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          14
        10. group Id
          BG009
          value
          35
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          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
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          10
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          14
        10. group Id
          BG009
          value
          31
        title
        White
      6. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0

Preserved source evidence · Not medical advice