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NCT02681302 · BASELINE

Baseline characteristics

Check Point Inhibition After Autologous Stem Cell Transplantation in Patients at High Risk of Post Transplant Recurrence · Source last updated 2026-04-03

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
      9
    2. group Id
      BG001
      value
      11
    3. group Id
      BG002
      value
      8
    4. group Id
      BG003
      value
      4
    5. group Id
      BG004
      value
      8
    6. group Id
      BG005
      value
      6
    7. group Id
      BG006
      value
      46
    units
    Participants
groups
  1. description
    De novo diffuse large B cell lymphoma that fails to achieve a PET negative complete response to primary rituximab and anthracycline based multi-agent chemotherapy and at least maintains stable disease after salvage chemotherapy or present double/triple hit features defined by overexpression by standard immunohistochemistry of c-MYC plus BCL2 and/or BCL6 or presence of chromosomal translocations as detected by break-apart FISH involving IGH/MYC plus IGH/BCL2 and/or IGH/BCL6 and who only received standard chemoimmunotherapy with rituximab, cyclophosphamide, vincristine and prednisone (R-CHOP) for induction and present at least stable disease after consolidation or salvage chemotherapy. Stable disease (SD) for lymphoma is defined in Appendix B: Lugano Classification for Response Assessment of Non-Hodgkin Lymphoma.
    id
    BG000
    title
    Group A
  2. description
    Recurrent high-risk diffuse large B cell lymphoma defined as relapsing within one year of completion of rituximab and anthracycline based multi-agent chemotherapy or a sAAIPI (second-line age-adjusted International Prognostic Index) intermediate or high at relapse or acquisition of double/triple hit features upon relapse (as defined in group A) and at least stable disease after salvage chemotherapy. Patients with an initial diagnosis of low-grade/indolent non-Hodgkin lymphoma (i.e. follicular, marginal zone) who present relapse with histologic transformation to diffuse large B cell lymphoma (confirmed by biopsy) and meet the definition for high-risk as presented above, are also eligible.
    id
    BG001
    title
    Group B
  3. description
    De novo high-risk T cell lymphoma with at least stable disease after primary therapy. High risk T cell lymphoma is defined as Stage III or IV disease at presentation and/or failure to achieve CR after frontline chemotherapy. Patients with ALK-positive ALCL will be excluded from the trial. Patients with ALK-negative ALCL in complete response will be excluded from the trial.
    id
    BG002
    title
    Group C
  4. description
    Recurrent T cell lymphoma with at least stable disease after salvage therapy. Patients with ALK-positive ALCL will be excluded from the trial.
    id
    BG003
    title
    Group D
  5. description
    Transplant-naïve high risk multiple myeloma with at least stable disease after most recent line of therapy. High risk myeloma is defined as those carrying 1q amplifications, 1p deletions, 13q deletions by conventional cytogenetics, p53 deletions, high-risk GEP 70 scores, t(4;14), t(14;16) and t(14;20), hypodiploidy. This cohort has been discontinued due to updated risks provided by the FDA. These patients will be followed for safety and correlative studies only.
    id
    BG004
    title
    Group E
  6. description
    Recurrent myeloma within 3 years after a single or tandem autologous transplant and at least stable disease after salvage therapy. Stable disease for multiple myeloma is defined in Appendix C: International Myeloma Working Group (IMWG). This cohort has been discontinued due to updated risks provided by the FDA. These patients will be followed for safety and correlative studies only.
    id
    BG005
    title
    Group F
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. 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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          27
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          19
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          21
          upper Limit
          60
          value
          51
        2. group Id
          BG001
          lower Limit
          41
          upper Limit
          75
          value
          66
        3. group Id
          BG002
          lower Limit
          35
          upper Limit
          69
          value
          57
        4. group Id
          BG003
          lower Limit
          26
          upper Limit
          72
          value
          52
        5. group Id
          BG004
          lower Limit
          65
          upper Limit
          78
          value
          69.5
        6. group Id
          BG005
          lower Limit
          48
          upper Limit
          76
          value
          50.5
        7. group Id
          BG006
          lower Limit
          21
          upper Limit
          78
          value
          62
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          35
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    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
        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
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          5
        title
        Asian
      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
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          34
        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
        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
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        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
          9
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          46
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      9
    2. group Id
      BG001
      value
      11
    3. group Id
      BG002
      value
      8
    4. group Id
      BG003
      value
      4
    5. group Id
      BG004
      value
      8
    6. group Id
      BG005
      value
      6
    7. group Id
      BG006
      value
      46
    units
    Participants
groups
  1. description
    De novo diffuse large B cell lymphoma that fails to achieve a PET negative complete response to primary rituximab and anthracycline based multi-agent chemotherapy and at least maintains stable disease after salvage chemotherapy or present double/triple hit features defined by overexpression by standard immunohistochemistry of c-MYC plus BCL2 and/or BCL6 or presence of chromosomal translocations as detected by break-apart FISH involving IGH/MYC plus IGH/BCL2 and/or IGH/BCL6 and who only received standard chemoimmunotherapy with rituximab, cyclophosphamide, vincristine and prednisone (R-CHOP) for induction and present at least stable disease after consolidation or salvage chemotherapy. Stable disease (SD) for lymphoma is defined in Appendix B: Lugano Classification for Response Assessment of Non-Hodgkin Lymphoma.
    id
    BG000
    title
    Group A
  2. description
    Recurrent high-risk diffuse large B cell lymphoma defined as relapsing within one year of completion of rituximab and anthracycline based multi-agent chemotherapy or a sAAIPI (second-line age-adjusted International Prognostic Index) intermediate or high at relapse or acquisition of double/triple hit features upon relapse (as defined in group A) and at least stable disease after salvage chemotherapy. Patients with an initial diagnosis of low-grade/indolent non-Hodgkin lymphoma (i.e. follicular, marginal zone) who present relapse with histologic transformation to diffuse large B cell lymphoma (confirmed by biopsy) and meet the definition for high-risk as presented above, are also eligible.
    id
    BG001
    title
    Group B
  3. description
    De novo high-risk T cell lymphoma with at least stable disease after primary therapy. High risk T cell lymphoma is defined as Stage III or IV disease at presentation and/or failure to achieve CR after frontline chemotherapy. Patients with ALK-positive ALCL will be excluded from the trial. Patients with ALK-negative ALCL in complete response will be excluded from the trial.
    id
    BG002
    title
    Group C
  4. description
    Recurrent T cell lymphoma with at least stable disease after salvage therapy. Patients with ALK-positive ALCL will be excluded from the trial.
    id
    BG003
    title
    Group D
  5. description
    Transplant-naïve high risk multiple myeloma with at least stable disease after most recent line of therapy. High risk myeloma is defined as those carrying 1q amplifications, 1p deletions, 13q deletions by conventional cytogenetics, p53 deletions, high-risk GEP 70 scores, t(4;14), t(14;16) and t(14;20), hypodiploidy. This cohort has been discontinued due to updated risks provided by the FDA. These patients will be followed for safety and correlative studies only.
    id
    BG004
    title
    Group E
  6. description
    Recurrent myeloma within 3 years after a single or tandem autologous transplant and at least stable disease after salvage therapy. Stable disease for multiple myeloma is defined in Appendix C: International Myeloma Working Group (IMWG). This cohort has been discontinued due to updated risks provided by the FDA. These patients will be followed for safety and correlative studies only.
    id
    BG005
    title
    Group F
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. 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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          27
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          19
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          21
          upper Limit
          60
          value
          51
        2. group Id
          BG001
          lower Limit
          41
          upper Limit
          75
          value
          66
        3. group Id
          BG002
          lower Limit
          35
          upper Limit
          69
          value
          57
        4. group Id
          BG003
          lower Limit
          26
          upper Limit
          72
          value
          52
        5. group Id
          BG004
          lower Limit
          65
          upper Limit
          78
          value
          69.5
        6. group Id
          BG005
          lower Limit
          48
          upper Limit
          76
          value
          50.5
        7. group Id
          BG006
          lower Limit
          21
          upper Limit
          78
          value
          62
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          35
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    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
        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
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          5
        title
        Asian
      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
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          34
        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
        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
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        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
          9
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          46
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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