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NCT02797470 · BASELINE

Baseline characteristics

Gene Therapy in Treating Patients With Human Immunodeficiency Virus-Related Lymphoma Receiving Stem Cell Transplant · Source last updated 2026-05-18

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
      11
    units
    Participants
groups
  1. description
    Patients receive BEAM regimen administered as standard of care comprising carmustine on day -6, cytarabine BID on days -5 to -2, etoposide BID on days -5 to -2, and melphalan on day -1. Patients undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells over 1 hour. Autologous Hematopoietic Stem Cell Transplantation: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells Carmustine: 300 mg/m2 on Day -6, as part of BEAM and R-BEAM regimens. Cytarabine: 100 mg/m2 BID on Days -5 through -2, as part of BEAM and R-BEAM regimens. Etoposide: VP-16: 100 mg/m2 BID on Days -5 through -2, as part of BEAM and R-BEAM regimens. Laboratory Biomarker Analysis: Correlative studies Lentivirus Vector CCR5 shRNA/TRIM5alpha/TAR Decoy-transduced Autologous CD34-positive Hematopoietic Progenitor Cells: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells Melphalan: 140 mg/m2 on Day -1, as part of BEAM and R-BEAM regimens. Peripheral Blood Stem Cell Transplantation: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells
    id
    BG000
    title
    Treatment (Anti-HIV Gene Transduced CD34+ Cells)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.4
          value
          61
      denoms
      1. counts
        1. group Id
          BG000
          value
          5
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:0 Ratio
    2. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.7
          value
          51
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:1 Ratio
    3. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.9
          value
          61
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 5:1 Ratio
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Patients per arm were displayed.
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          5
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:0 Ratio
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:1 Ratio
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 5:1 Ratio
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Patients per arm were displayed.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          5
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:0 Ratio
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:1 Ratio
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 5:1 Ratio
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Patients per arm were displayed.
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          5
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:0 Ratio
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:1 Ratio
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          2
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 5:1 Ratio
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Patients per arm were displayed.
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          5
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:0 Ratio
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:1 Ratio
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 5:1 Ratio
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Patients per arm were displayed.
    title
    Bone Marrow Biopsy status
    unit Of Measure
    Participants
population Description
Participants received Stem Cell Gene Therapy
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      11
    units
    Participants
groups
  1. description
    Patients receive BEAM regimen administered as standard of care comprising carmustine on day -6, cytarabine BID on days -5 to -2, etoposide BID on days -5 to -2, and melphalan on day -1. Patients undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells over 1 hour. Autologous Hematopoietic Stem Cell Transplantation: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells Carmustine: 300 mg/m2 on Day -6, as part of BEAM and R-BEAM regimens. Cytarabine: 100 mg/m2 BID on Days -5 through -2, as part of BEAM and R-BEAM regimens. Etoposide: VP-16: 100 mg/m2 BID on Days -5 through -2, as part of BEAM and R-BEAM regimens. Laboratory Biomarker Analysis: Correlative studies Lentivirus Vector CCR5 shRNA/TRIM5alpha/TAR Decoy-transduced Autologous CD34-positive Hematopoietic Progenitor Cells: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells Melphalan: 140 mg/m2 on Day -1, as part of BEAM and R-BEAM regimens. Peripheral Blood Stem Cell Transplantation: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells
    id
    BG000
    title
    Treatment (Anti-HIV Gene Transduced CD34+ Cells)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.4
          value
          61
      denoms
      1. counts
        1. group Id
          BG000
          value
          5
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:0 Ratio
    2. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.7
          value
          51
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:1 Ratio
    3. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.9
          value
          61
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 5:1 Ratio
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Patients per arm were displayed.
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          5
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:0 Ratio
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:1 Ratio
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 5:1 Ratio
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Patients per arm were displayed.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          5
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:0 Ratio
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:1 Ratio
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 5:1 Ratio
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Patients per arm were displayed.
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          5
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:0 Ratio
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:1 Ratio
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          2
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 5:1 Ratio
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Patients per arm were displayed.
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          5
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:0 Ratio
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:1 Ratio
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        units
        Participants
      title
      Treatment (Anti-HIV Gene Transduced CD34+ Cells): 5:1 Ratio
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Patients per arm were displayed.
    title
    Bone Marrow Biopsy status
    unit Of Measure
    Participants
population Description
Participants received Stem Cell Gene Therapy

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