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NCT04251065 · BASELINE

Baseline characteristics

Daratumumab Plus Gemcitabine, Dexamethasone, Cisplatin in pt R/R CD38+ PTCL-NOS, AITL and TFH · Source last updated 2025-03-28

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
      8
    units
    Participants
groups
  1. description
    Daratumumab in combination with Gemcitabine, Dexamethasone and Cisplatin (D-GDP) in patients with relapsed/refractory CD38 positive peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of TFH cell origin.
    id
    BG000
    title
    One Arm
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          62.0
          upper Limit
          72.5
          value
          64.5
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        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
          8
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          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
          5
        title
        Relapse
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Refractory
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease status at study entry
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        title
        Absent
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Present
    description
    Symptoms B: absence of systemic symptoms; systemic symptoms defined as Night sweating, fever or Weight loss.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Systemic B symptoms
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        III
      2. measurements
        1. group Id
          BG000
          value
          7
        title
        IV
    description
    Staging for lymphomas disease, ranging from I (disease located in single region) to IV (diffuse or disseminated involvement of one or more extralymphatic organs)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ann Arbor Stage
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        1
    description
    ECOG Performance status: scale ranging from 0 (person fully active) to 5 (death)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        title
        Negative
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Positive
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Bone marrow involvement
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        1
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        2
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        3
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        4
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        5
    description
    Extranodal localization by CT scan or combined PET-CT (Magnetic Resonance Imaging if CT cannot be done).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number extra-nodal sites
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        6 cy CHOEP + 1 cy DHAP + ASCT
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        6 cy CHOP+DHAP+ASCT
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        CHOEP
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        6cy CHOEP + ARA-C + ABMT
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        CHOP
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        COEP
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        CHOEP +HSCT
    description
    CHOEP: cyclophosphamide doxorubicin vincristine Etoposide Prednisone DHAP: rituximab dexamethasone cytarabine cisplatin ASCT: autologous stem cell transplant ARA-C: cytarabine CHOP: cyclophosphamide doxorubicine vincristine prednisone COEP: cyclophosphamide etoposide vincristine prednisone HSCT: haematopoietic stem cell transplantation
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Type of the 1st Line Treatment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      8
    units
    Participants
groups
  1. description
    Daratumumab in combination with Gemcitabine, Dexamethasone and Cisplatin (D-GDP) in patients with relapsed/refractory CD38 positive peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of TFH cell origin.
    id
    BG000
    title
    One Arm
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          62.0
          upper Limit
          72.5
          value
          64.5
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        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
          8
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          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
          5
        title
        Relapse
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Refractory
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease status at study entry
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        title
        Absent
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Present
    description
    Symptoms B: absence of systemic symptoms; systemic symptoms defined as Night sweating, fever or Weight loss.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Systemic B symptoms
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        III
      2. measurements
        1. group Id
          BG000
          value
          7
        title
        IV
    description
    Staging for lymphomas disease, ranging from I (disease located in single region) to IV (diffuse or disseminated involvement of one or more extralymphatic organs)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ann Arbor Stage
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        1
    description
    ECOG Performance status: scale ranging from 0 (person fully active) to 5 (death)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        title
        Negative
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Positive
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Bone marrow involvement
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        1
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        2
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        3
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        4
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        5
    description
    Extranodal localization by CT scan or combined PET-CT (Magnetic Resonance Imaging if CT cannot be done).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number extra-nodal sites
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        6 cy CHOEP + 1 cy DHAP + ASCT
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        6 cy CHOP+DHAP+ASCT
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        CHOEP
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        6cy CHOEP + ARA-C + ABMT
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        CHOP
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        COEP
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        CHOEP +HSCT
    description
    CHOEP: cyclophosphamide doxorubicin vincristine Etoposide Prednisone DHAP: rituximab dexamethasone cytarabine cisplatin ASCT: autologous stem cell transplant ARA-C: cytarabine CHOP: cyclophosphamide doxorubicine vincristine prednisone COEP: cyclophosphamide etoposide vincristine prednisone HSCT: haematopoietic stem cell transplantation
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Type of the 1st Line Treatment
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice