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NCT00245037 · BASELINE

Baseline characteristics

Busulfan, Fludarabine, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer · Source last updated 2017-09-27

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
      147
    units
    Participants
groups
  1. description
    Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0 Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species. Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative. IV Busulfan is available and diluted and administered per package insert guidelines. Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including
    id
    BG000
    title
    Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          81
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          66
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          147
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          98
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          147
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          91
        title
        KPS ≥ 90
      2. measurements
        1. group Id
          BG000
          value
          48
        title
        KPS < 90
      denoms
      1. counts
        1. group Id
          BG000
          value
          139
        units
        Participants
    description
    KPS Scale: 100 = Normal, no complaints, no evidence of disease. 90 = Able to carry on normal activity; minor signs or symptoms of disease. 80 = Normal activity with effort; some signs or symptoms of disease. 70 = Cares for self, unable to carry on normal activity or to do active work. 60 = Requires occasional assistance, but is able to care for most of his/her needs. 50 = Requires considerable assistance and frequent medical care. 40-0 = Not eligible
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Eight patients did not have KPS status available, which is why the values do not add up to the total number of participants.
    title
    Karnofsky Performance Score (KPS)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          85
        title
        In Complete Remission
      2. measurements
        1. group Id
          BG000
          value
          62
        title
        Not in Complete Remission
      denoms
      1. counts
        1. group Id
          BG000
          value
          147
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Pre-Transplant Disease Status
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          93
        title
        Low or intermediate
      2. measurements
        1. group Id
          BG000
          value
          51
        title
        High or Very High
      denoms
      1. counts
        1. group Id
          BG000
          value
          144
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    DRI was unclassifiable in 3 patients.
    title
    Disease Risk Index (DRI)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          135
        title
        8/8
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        7/8
      denoms
      1. counts
        1. group Id
          BG000
          value
          147
        units
        Participants
    description
    HLA Criteria: Related to the patient and genotypically or phenotypically HLA-identical (8/8). Single antigen mismatch (7/8) can be accepted if no other donor is available. OR Unrelated to the patient and HLA matched by molecular typing, allowing a single allele or antigen mismatch (7/8).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    HLA Match
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        title
        Related Sibling Donor
      2. measurements
        1. group Id
          BG000
          value
          108
        title
        Unrelated Donor
      denoms
      1. counts
        1. group Id
          BG000
          value
          147
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Donor Relation
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        title
        -/- recipient/donor
      2. measurements
        1. group Id
          BG000
          value
          118
        title
        All other combinations
      denoms
      1. counts
        1. group Id
          BG000
          value
          140
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Cytomegalovirus (CMV) status was unavailable in 7 patients.
    title
    Cytomegalovirus (CMV) Status
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          117
        title
        F/F, M/M, M/F
      2. measurements
        1. group Id
          BG000
          value
          30
        title
        F/M
      denoms
      1. counts
        1. group Id
          BG000
          value
          147
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Donor/Recipient Gender
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      147
    units
    Participants
groups
  1. description
    Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0 Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species. Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative. IV Busulfan is available and diluted and administered per package insert guidelines. Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including
    id
    BG000
    title
    Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          81
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          66
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          147
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          98
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          147
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          91
        title
        KPS ≥ 90
      2. measurements
        1. group Id
          BG000
          value
          48
        title
        KPS < 90
      denoms
      1. counts
        1. group Id
          BG000
          value
          139
        units
        Participants
    description
    KPS Scale: 100 = Normal, no complaints, no evidence of disease. 90 = Able to carry on normal activity; minor signs or symptoms of disease. 80 = Normal activity with effort; some signs or symptoms of disease. 70 = Cares for self, unable to carry on normal activity or to do active work. 60 = Requires occasional assistance, but is able to care for most of his/her needs. 50 = Requires considerable assistance and frequent medical care. 40-0 = Not eligible
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Eight patients did not have KPS status available, which is why the values do not add up to the total number of participants.
    title
    Karnofsky Performance Score (KPS)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          85
        title
        In Complete Remission
      2. measurements
        1. group Id
          BG000
          value
          62
        title
        Not in Complete Remission
      denoms
      1. counts
        1. group Id
          BG000
          value
          147
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Pre-Transplant Disease Status
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          93
        title
        Low or intermediate
      2. measurements
        1. group Id
          BG000
          value
          51
        title
        High or Very High
      denoms
      1. counts
        1. group Id
          BG000
          value
          144
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    DRI was unclassifiable in 3 patients.
    title
    Disease Risk Index (DRI)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          135
        title
        8/8
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        7/8
      denoms
      1. counts
        1. group Id
          BG000
          value
          147
        units
        Participants
    description
    HLA Criteria: Related to the patient and genotypically or phenotypically HLA-identical (8/8). Single antigen mismatch (7/8) can be accepted if no other donor is available. OR Unrelated to the patient and HLA matched by molecular typing, allowing a single allele or antigen mismatch (7/8).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    HLA Match
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        title
        Related Sibling Donor
      2. measurements
        1. group Id
          BG000
          value
          108
        title
        Unrelated Donor
      denoms
      1. counts
        1. group Id
          BG000
          value
          147
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Donor Relation
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        title
        -/- recipient/donor
      2. measurements
        1. group Id
          BG000
          value
          118
        title
        All other combinations
      denoms
      1. counts
        1. group Id
          BG000
          value
          140
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Cytomegalovirus (CMV) status was unavailable in 7 patients.
    title
    Cytomegalovirus (CMV) Status
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          117
        title
        F/F, M/M, M/F
      2. measurements
        1. group Id
          BG000
          value
          30
        title
        F/M
      denoms
      1. counts
        1. group Id
          BG000
          value
          147
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Donor/Recipient Gender
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice