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NCT00632827 · BASELINE

Baseline characteristics

Treatment of PTCL With Aggressive Induction Therapy Followed by Autologous SCT Using Denileukin Diftitox (Ontak) · Source last updated 2020-04-27

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
      21
    units
    Participants
groups
  1. description
    (1) Induction Chemo A; Two 21-day cycles of Gemcitabine 1000 mg/m2 days 1, 8, Navelbine 20 mg/m2 day 1, 8; Doxil 15 mg/m2 Days 1, 8, Granulocyte-colony stimulating factor(G-CSF) Days 4-6 and 10-15 (2) Induction Chemo B: Two 21-day cycles of Cyclophosphamide 2000 mg/m2 day 1; Doxorubicin 50 mg/m2 day 1; Vincristine 1.4 mg/m2 day 1; Prednisone 100 mg/m2 days 1-5; Methotrexate 3000 mg/m2 IV over 4h day 15; Leucovorin rescue (3) Disease Evaluation (4) High-dose Consolidation Chemo, high dose Ara-C, Denileukin diftitox (Ontak) and Stem Cell Collection (5) Consolidation Cytarabine 2000 mg/m2 IV over 2 h q 12h days 1-4, Etoposide 40 mg/m2 continuous intravenous infusion days 1-4, Denileukin Diftitox (Ontak) 9 mcg/kg/day days 6-10, G-CSF 10 mcg/kg/day day 14+, Stem cell collection day 22 (6) Autologous Stem Cell Transplant Carmustine 550 mg/m2 day 1-6, Etoposide 60 mg/kg IV over 4h day -4, Cyclophosphamide 100 mg/kg day -2, Stem cell infusion day 0 (7) Post-transplant: Denileukin diftitox
    id
    BG000
    title
    Treatment Plan
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          26
          upper Limit
          68
          value
          58
    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
          8
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          13
        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
          21
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        title
        Angioimmunoblastic T-cell lymphoma (AILT)
      2. measurements
        1. group Id
          BG000
          value
          9
        title
        Peripheral T-cell lymphoma (PTCL) not classified
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Enteropathy-associated T-cell lymphoma
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Subcutaneous panniculitis-like T-cell Lymphoma
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        Hepato-Splenic gamma-delta T-cell Lymphoma
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        Anaplastic large cell lymphoma, ALK-
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Histology
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        title
        Bone Marrow
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Skin
      3. measurements
        1. group Id
          BG000
          value
          3
        title
        Bone
      4. measurements
        1. group Id
          BG000
          value
          2
        title
        Gastrointestinal
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        Lung
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        Liver
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Thyroid
      8. measurements
        1. group Id
          BG000
          value
          3
        title
        No extranodal site
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Extranodal Sites
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Stage I/II
      2. measurements
        1. group Id
          BG000
          value
          7
        title
        Stage III
      3. measurements
        1. group Id
          BG000
          value
          14
        title
        Stage IV
    description
    The American Joint Committee on Cancer (AJCC) and the International Union for Cancer Control (UICC) maintain the classification system as a tool for doctors to stage different types of cancer based on certain standards. The stage refers to the extent of your cancer, such as how large the tumor is, and if it has spread. A cancer is always referred to by the stage it was given at diagnosis and is assigned a roman numeral from 0 to IV, where stage 0 is the least severe and stage 4 (IV) is the more severe and the cancer is more advanced than in the lower stages
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Stage
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Lactate Dehydrogenase (LDH)> normal
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        title
        Score of 2
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        Score of 3
      3. measurements
        1. group Id
          BG000
          value
          3
        title
        Score of >=4
    description
    The International Prognostic Index (IPI) is a clinical tool developed by oncologists to aid in predicting the prognosis of patients. The score range is 0-5 with lower scores indicating a lower risk of death and higher scores indicating a greater risk of death.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International prognostic index (IPI) score
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      21
    units
    Participants
groups
  1. description
    (1) Induction Chemo A; Two 21-day cycles of Gemcitabine 1000 mg/m2 days 1, 8, Navelbine 20 mg/m2 day 1, 8; Doxil 15 mg/m2 Days 1, 8, Granulocyte-colony stimulating factor(G-CSF) Days 4-6 and 10-15 (2) Induction Chemo B: Two 21-day cycles of Cyclophosphamide 2000 mg/m2 day 1; Doxorubicin 50 mg/m2 day 1; Vincristine 1.4 mg/m2 day 1; Prednisone 100 mg/m2 days 1-5; Methotrexate 3000 mg/m2 IV over 4h day 15; Leucovorin rescue (3) Disease Evaluation (4) High-dose Consolidation Chemo, high dose Ara-C, Denileukin diftitox (Ontak) and Stem Cell Collection (5) Consolidation Cytarabine 2000 mg/m2 IV over 2 h q 12h days 1-4, Etoposide 40 mg/m2 continuous intravenous infusion days 1-4, Denileukin Diftitox (Ontak) 9 mcg/kg/day days 6-10, G-CSF 10 mcg/kg/day day 14+, Stem cell collection day 22 (6) Autologous Stem Cell Transplant Carmustine 550 mg/m2 day 1-6, Etoposide 60 mg/kg IV over 4h day -4, Cyclophosphamide 100 mg/kg day -2, Stem cell infusion day 0 (7) Post-transplant: Denileukin diftitox
    id
    BG000
    title
    Treatment Plan
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          26
          upper Limit
          68
          value
          58
    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
          8
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          13
        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
          21
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        title
        Angioimmunoblastic T-cell lymphoma (AILT)
      2. measurements
        1. group Id
          BG000
          value
          9
        title
        Peripheral T-cell lymphoma (PTCL) not classified
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Enteropathy-associated T-cell lymphoma
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Subcutaneous panniculitis-like T-cell Lymphoma
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        Hepato-Splenic gamma-delta T-cell Lymphoma
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        Anaplastic large cell lymphoma, ALK-
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Histology
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        title
        Bone Marrow
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Skin
      3. measurements
        1. group Id
          BG000
          value
          3
        title
        Bone
      4. measurements
        1. group Id
          BG000
          value
          2
        title
        Gastrointestinal
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        Lung
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        Liver
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Thyroid
      8. measurements
        1. group Id
          BG000
          value
          3
        title
        No extranodal site
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Extranodal Sites
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Stage I/II
      2. measurements
        1. group Id
          BG000
          value
          7
        title
        Stage III
      3. measurements
        1. group Id
          BG000
          value
          14
        title
        Stage IV
    description
    The American Joint Committee on Cancer (AJCC) and the International Union for Cancer Control (UICC) maintain the classification system as a tool for doctors to stage different types of cancer based on certain standards. The stage refers to the extent of your cancer, such as how large the tumor is, and if it has spread. A cancer is always referred to by the stage it was given at diagnosis and is assigned a roman numeral from 0 to IV, where stage 0 is the least severe and stage 4 (IV) is the more severe and the cancer is more advanced than in the lower stages
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Stage
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Lactate Dehydrogenase (LDH)> normal
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        title
        Score of 2
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        Score of 3
      3. measurements
        1. group Id
          BG000
          value
          3
        title
        Score of >=4
    description
    The International Prognostic Index (IPI) is a clinical tool developed by oncologists to aid in predicting the prognosis of patients. The score range is 0-5 with lower scores indicating a lower risk of death and higher scores indicating a greater risk of death.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International prognostic index (IPI) score
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice