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NCT01640301 · ADVERSE EVENTS

Adverse events

Laboratory-Treated T Cells in Treating Patients With High-Risk Relapsed Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia Previously Treated With Donor Stem Cell Transplant · Source last updated 2022-07-14

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
Up to 1 year post infusion per patient
Other-event reporting threshold
0%

Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (High-risk for Relapse After HCT)

Patients with no evidence of leukemia or MDS post-HCT receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 14 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV

5 / 1312 / 130 / 13
Arm II (Relapsed After HCT)

Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV

5 / 1515 / 158 / 15

Group identifiers: EG000: Arm I (High-risk for Relapse After HCT) · EG001: Arm II (Relapsed After HCT)

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Pericardial Effusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Duodenal obstruction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Multi-organ failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Fever
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Appendicitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Wound infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Lung Infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Fall
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    CPK Increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Hypercalcemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Acute kidney injury

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
      num Events
      16
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      15
      num Events
      18
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Sinus tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
      num Events
      2
    term
    Mucositis oral
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
      num Events
      2
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Rectal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Chills
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
      num Events
      2
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Fever
Complete source fields
description
Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    13
    description
    Patients with no evidence of leukemia or MDS post-HCT receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 14 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    13
    serious Num Affected
    5
    serious Num At Risk
    13
    title
    Arm I (High-risk for Relapse After HCT)
  2. deaths Num Affected
    8
    deaths Num At Risk
    15
    description
    Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV
    id
    EG001
    other Num Affected
    15
    other Num At Risk
    15
    serious Num Affected
    5
    serious Num At Risk
    15
    title
    Arm II (Relapsed After HCT)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
      num Events
      16
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      15
      num Events
      18
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Sinus tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
      num Events
      2
    term
    Mucositis oral
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
      num Events
      2
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Rectal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Chills
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
      num Events
      2
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Fever
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Pericardial Effusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Duodenal obstruction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Multi-organ failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Fever
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Appendicitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Wound infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    term
    Lung Infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Fall
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    CPK Increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Hypercalcemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    term
    Acute kidney injury
time Frame
Up to 1 year post infusion per patient

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