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NCT05316701 · BASELINE

Baseline characteristics

Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies · Source last updated 2026-03-04

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
      93
    2. group Id
      BG001
      value
      94
    3. group Id
      BG002
      value
      187
    units
    Participants
groups
  1. description
    Orca-T administered after myeloablative conditioning followed by single-agent tacrolimus
    id
    BG000
    title
    Orca-T
  2. description
    Unmanipulated allograft from peripheral blood of a matched donor after myeloablative conditioning followed by tacrolimus and methotrexate
    id
    BG001
    title
    Standard of Care
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          93
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          187
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          value
          40
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          84
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          103
        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
          26
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          50
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          59
        3. group Id
          BG002
          value
          121
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          16
        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
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          18
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          139
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          22
        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
          93
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          187
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
        title
        Acute Lymphoid Leukemia (ALL)
      2. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          100
        title
        Acute Myeloid Leukemia (AML)
      3. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          23
        title
        High-risk Myelodysplastic Syndrome (MDS)
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        title
        Mixed Phenotype Acute Leukemia (MPAL)
    description
    Primary disease at enrollment
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary Disease
    unit Of Measure
    Participants
population Description
Intent-to-Treat (ITT): All enrolled participants who were randomized to either Orca-T or standard of care (SoC), regardless of whether they received Orca-T/SoC or not; participants were analyzed according to their randomized treatment assignment
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      93
    2. group Id
      BG001
      value
      94
    3. group Id
      BG002
      value
      187
    units
    Participants
groups
  1. description
    Orca-T administered after myeloablative conditioning followed by single-agent tacrolimus
    id
    BG000
    title
    Orca-T
  2. description
    Unmanipulated allograft from peripheral blood of a matched donor after myeloablative conditioning followed by tacrolimus and methotrexate
    id
    BG001
    title
    Standard of Care
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          93
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          187
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          value
          40
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          84
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          103
        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
          26
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          50
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          59
        3. group Id
          BG002
          value
          121
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          16
        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
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          18
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          139
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          22
        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
          93
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          187
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
        title
        Acute Lymphoid Leukemia (ALL)
      2. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          100
        title
        Acute Myeloid Leukemia (AML)
      3. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          23
        title
        High-risk Myelodysplastic Syndrome (MDS)
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        title
        Mixed Phenotype Acute Leukemia (MPAL)
    description
    Primary disease at enrollment
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary Disease
    unit Of Measure
    Participants
population Description
Intent-to-Treat (ITT): All enrolled participants who were randomized to either Orca-T or standard of care (SoC), regardless of whether they received Orca-T/SoC or not; participants were analyzed according to their randomized treatment assignment

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Preserved source evidence · Not medical advice