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NCT05350163 · ADVERSE EVENTS

Adverse events

T-cell Receptor α/β Depleted Donor Lymphocyte Infusion · Source last updated 2024-12-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
The longest any participant was on study was approximately 14 months.
Other-event reporting threshold
0%

The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
HLA Matched Cohort I

5 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients

6 / 1010 / 105 / 10
HLA Matched Cohort II

5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients

0 / 00 / 00 / 0
HLA Matched Cohort III

5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 2 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients

0 / 00 / 00 / 0
HLA Mismatched Cohort I

1 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients

1 / 11 / 11 / 1
HLA Mismatched Cohort II

1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 5 x 10\^5/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients

0 / 00 / 00 / 0
HLA Mismatched Cohort III

1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients

0 / 00 / 00 / 0

Group identifiers: EG000: HLA Matched Cohort I · EG001: HLA Matched Cohort II · EG002: HLA Matched Cohort III · EG003: HLA Mismatched Cohort I · EG004: HLA Mismatched Cohort II · EG005: HLA Mismatched Cohort III

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Lung infection
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Upper respiratory infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Chest pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Cognitive disturbance
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Colitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Decreased platelet count
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Generalized muscle weakness
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Pleuritic pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Rash maculo-papular
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Respiratory failure

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Diarrhea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Epstein-Barr virus infection reactivation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Fatigue
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Febrile neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Viremia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Arthralgia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Appendicitis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Back pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Bacteremia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Other, Large B cell lymphoma
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Conjunctivitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Decreased platelet count
Complete source fields
description
The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    10
    description
    5 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
    id
    EG000
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    6
    serious Num At Risk
    10
    title
    HLA Matched Cohort I
  2. deaths Num Affected
    0
    deaths Num At Risk
    0
    description
    5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
    id
    EG001
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    HLA Matched Cohort II
  3. deaths Num Affected
    0
    deaths Num At Risk
    0
    description
    5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 2 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
    id
    EG002
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    HLA Matched Cohort III
  4. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    1 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
    id
    EG003
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    HLA Mismatched Cohort I
  5. deaths Num Affected
    0
    deaths Num At Risk
    0
    description
    1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 5 x 10\^5/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
    id
    EG004
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    HLA Mismatched Cohort II
  6. deaths Num Affected
    0
    deaths Num At Risk
    0
    description
    1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
    id
    EG005
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    HLA Mismatched Cohort III
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Diarrhea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Epstein-Barr virus infection reactivation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Fatigue
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Febrile neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Viremia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Arthralgia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Appendicitis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Back pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Bacteremia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Other, Large B cell lymphoma
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Conjunctivitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Decreased platelet count
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Lung infection
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Upper respiratory infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Chest pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Cognitive disturbance
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Colitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Decreased platelet count
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Generalized muscle weakness
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Pleuritic pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Rash maculo-papular
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Respiratory failure
time Frame
The longest any participant was on study was approximately 14 months.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice