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NCT01773395 · ADVERSE EVENTS

Adverse events

GVAX vs. Placebo for MDS/AML After Allo HSCT · Source last updated 2022-07-18

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
18 Months
Other-event reporting threshold
0%

Patients were monitored for local and systemic adverse reactions with weekly to twice weekly examinations and laboratory studies during the study period. Acute graft-versus host disease (GVHD) was graded according to Keystone criteria.19 Non-GVHD adverse events were reported according to the National Cancer Institute Common Toxicity Criteria v.4 guidelines.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
GVAX

GVAX vaccine Participants in the GVAX vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD. Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan. Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor. GVHD Prevention: * Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months. * Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant. GVAX: GVAX vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria.

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Placebo

Placebo vaccine Participants in the placebo vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD. Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan. Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor. GVHD Prevention: * Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months. * Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant. Placebo: Placebo vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria.

2 / 274 / 2713 / 27

Group identifiers: EG000: GVAX · EG001: Placebo

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
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    term
    Arthralgia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    term
    Hypoalbuminemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    term
    Blood bilirubin increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    term
    Alanine aminotransferase increased

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
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    term
    Erythema Multiforme
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    term
    Skin Induration
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    term
    Pruritus
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    term
    Rash acneiform
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    term
    Ventricular tachycardia
Complete source fields
description
Patients were monitored for local and systemic adverse reactions with weekly to twice weekly examinations and laboratory studies during the study period. Acute graft-versus host disease (GVHD) was graded according to Keystone criteria.19 Non-GVHD adverse events were reported according to the National Cancer Institute Common Toxicity Criteria v.4 guidelines.
event Groups
  1. deaths Num Affected
    14
    deaths Num At Risk
    30
    description
    GVAX vaccine Participants in the GVAX vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD. Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan. Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor. GVHD Prevention: * Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months. * Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant. GVAX: GVAX vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria.
    id
    EG000
    other Num Affected
    10
    other Num At Risk
    30
    serious Num Affected
    1
    serious Num At Risk
    30
    title
    GVAX
  2. deaths Num Affected
    13
    deaths Num At Risk
    27
    description
    Placebo vaccine Participants in the placebo vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD. Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan. Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor. GVHD Prevention: * Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months. * Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant. Placebo: Placebo vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria.
    id
    EG001
    other Num Affected
    4
    other Num At Risk
    27
    serious Num Affected
    2
    serious Num At Risk
    27
    title
    Placebo
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    term
    Erythema Multiforme
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    term
    Skin Induration
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    term
    Pruritus
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    term
    Rash acneiform
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    term
    Ventricular tachycardia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    term
    Arthralgia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    term
    Hypoalbuminemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    term
    Blood bilirubin increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    term
    Alanine aminotransferase increased
time Frame
18 Months

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Preserved source evidence · Not medical advice