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NCT02232516 · BASELINE

Baseline characteristics

Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma · Source last updated 2026-06-12

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
      29
    units
    Participants
groups
  1. description
    Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV lenalidomide: Given PO laboratory biomarker analysis: Correlative studies
    id
    BG000
    title
    Treatment (Romidepsin, Lenalidomide)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          49
          upper Limit
          84
          value
          75
      title
      Age at Registration
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Customized
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        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
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          22
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          4
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          21
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        I
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        II
      3. measurements
        1. group Id
          BG000
          value
          14
        title
        III
      4. measurements
        1. group Id
          BG000
          value
          13
        title
        IV
    description
    Ann Arbor Staging * I = Localized disease, single lymph node region or single organ * II = Two or more lymph node regions on the same side of diaphragm * III = Two or more lymph node regions above and below the diaphragm * IV = Widespread disease; multiple organs, with or without lymph node involvement
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stage
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          5
          value
          3
    description
    The International Prognostic Index (IPI) is a clinical tool developed by oncologists to aid in predicting the prognosis of patients with aggressive non-Hodgkin's lymphoma. One point is assigned for each of the following risk factors: * Age greater than 60 years * Stage III or IV disease * Elevated serum LDH * ECOG/Zubrod performance status of 2, 3, or 4 * More than 1 extranodal site The sum of the points allotted correlates with the following risk groups: * Low risk (0-1 points) * Low-intermediate risk (2 points) * High-intermediate risk (3 points) * High risk (4-5 points)
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    International Prognostic Index (IPI) Score
    unit Of Measure
    units on a scale
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          110
          upper Limit
          868
          value
          224
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Baseline LDH
    unit Of Measure
    U/L
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Adult T-Cell Leukemia/lymphoma
      2. measurements
        1. group Id
          BG000
          value
          16
        title
        Angioimmunoblastic T-cell Lymphoma
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Enteropathy-type T-cell Lymphoma
      4. measurements
        1. group Id
          BG000
          value
          10
        title
        Peripheral T-cell Lymphoma, unspecified
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Subtype
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        1
      2. measurements
        1. group Id
          BG000
          value
          6
        title
        2
      3. measurements
        1. group Id
          BG000
          value
          10
        title
        3
      4. measurements
        1. group Id
          BG000
          value
          11
        title
        4
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        5
    description
    The International Prognostic Index (IPI) is a clinical tool developed by oncologists to aid in predicting the prognosis of patients with aggressive non-Hodgkin's lymphoma. One point is assigned for each of the following risk factors: * Age greater than 60 years * Stage III or IV disease * Elevated serum LDH * ECOG/Zubrod performance status of 2, 3, or 4 * More than 1 extranodal site The sum of the points allotted correlates with the following risk groups: * Low risk (0-1 points) * Low-intermediate risk (2 points) * High-intermediate risk (3 points) * High risk (4-5 points)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Prognostic Index (IPI) Score - Discrete
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Indeterminate
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Negative
      3. measurements
        1. group Id
          BG000
          value
          16
        title
        Not Done
      4. measurements
        1. group Id
          BG000
          value
          7
        title
        Positive
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Bone Marrow Involvement
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          14
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          7
        title
        2
    description
    ECOG Performance Status * 0 = Fully active, able to carry on all pre-disease performance without restriction * 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work * 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours * 3 = Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours * 4 = Completely disabled; cannot carry on any selfcare; totally confined to bed or chair * 5 = Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
population Description
One patient did not start any study treatment and was statistically withdrawn.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      29
    units
    Participants
groups
  1. description
    Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV lenalidomide: Given PO laboratory biomarker analysis: Correlative studies
    id
    BG000
    title
    Treatment (Romidepsin, Lenalidomide)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          49
          upper Limit
          84
          value
          75
      title
      Age at Registration
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Customized
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        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
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          22
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          4
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          21
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        I
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        II
      3. measurements
        1. group Id
          BG000
          value
          14
        title
        III
      4. measurements
        1. group Id
          BG000
          value
          13
        title
        IV
    description
    Ann Arbor Staging * I = Localized disease, single lymph node region or single organ * II = Two or more lymph node regions on the same side of diaphragm * III = Two or more lymph node regions above and below the diaphragm * IV = Widespread disease; multiple organs, with or without lymph node involvement
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stage
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          5
          value
          3
    description
    The International Prognostic Index (IPI) is a clinical tool developed by oncologists to aid in predicting the prognosis of patients with aggressive non-Hodgkin's lymphoma. One point is assigned for each of the following risk factors: * Age greater than 60 years * Stage III or IV disease * Elevated serum LDH * ECOG/Zubrod performance status of 2, 3, or 4 * More than 1 extranodal site The sum of the points allotted correlates with the following risk groups: * Low risk (0-1 points) * Low-intermediate risk (2 points) * High-intermediate risk (3 points) * High risk (4-5 points)
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    International Prognostic Index (IPI) Score
    unit Of Measure
    units on a scale
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          110
          upper Limit
          868
          value
          224
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Baseline LDH
    unit Of Measure
    U/L
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Adult T-Cell Leukemia/lymphoma
      2. measurements
        1. group Id
          BG000
          value
          16
        title
        Angioimmunoblastic T-cell Lymphoma
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Enteropathy-type T-cell Lymphoma
      4. measurements
        1. group Id
          BG000
          value
          10
        title
        Peripheral T-cell Lymphoma, unspecified
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Subtype
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        1
      2. measurements
        1. group Id
          BG000
          value
          6
        title
        2
      3. measurements
        1. group Id
          BG000
          value
          10
        title
        3
      4. measurements
        1. group Id
          BG000
          value
          11
        title
        4
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        5
    description
    The International Prognostic Index (IPI) is a clinical tool developed by oncologists to aid in predicting the prognosis of patients with aggressive non-Hodgkin's lymphoma. One point is assigned for each of the following risk factors: * Age greater than 60 years * Stage III or IV disease * Elevated serum LDH * ECOG/Zubrod performance status of 2, 3, or 4 * More than 1 extranodal site The sum of the points allotted correlates with the following risk groups: * Low risk (0-1 points) * Low-intermediate risk (2 points) * High-intermediate risk (3 points) * High risk (4-5 points)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Prognostic Index (IPI) Score - Discrete
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Indeterminate
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Negative
      3. measurements
        1. group Id
          BG000
          value
          16
        title
        Not Done
      4. measurements
        1. group Id
          BG000
          value
          7
        title
        Positive
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Bone Marrow Involvement
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          14
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          7
        title
        2
    description
    ECOG Performance Status * 0 = Fully active, able to carry on all pre-disease performance without restriction * 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work * 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours * 3 = Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours * 4 = Completely disabled; cannot carry on any selfcare; totally confined to bed or chair * 5 = Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
population Description
One patient did not start any study treatment and was statistically withdrawn.

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Preserved source evidence · Not medical advice