Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02145403 · FLOW

Participant flow

Phase 1/2 Study of Carfilzomib for the Prevention of Relapse and GVHD in Allo-HCT for Hematologic Malignancies · Source last updated 2022-01-03

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

groups
  1. description
    Participants in all cohorts were administered 20 mg/m\^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Cohort 1: Participants were administered 20 mg/m\^2 of Carfilzomib on days +6 and +7. Participants in all cohorts were administered tacrolimus at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis.
    id
    FG000
    title
    Dose Level 1 - Maximum Dose Carfilzomib 20 mg/m^2
  2. description
    Participants in all cohorts were administered 20 mg/m\^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Cohort 2: Participants were administered 27 mg/m\^2 of Carfilzomib on days +6 and +7. Participants in all cohorts were administered tacrolimus at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis.
    id
    FG001
    title
    Dose Level 2 - Maximum Dose Carfilzomib 27 mg/m^2
  3. description
    Participants in all cohorts were administered 20 mg/m\^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Cohort 3: Participants were administered 36 mg/m\^2 of Carfilzomib on days +6 and +7. Participants in all cohorts were administered tacrolimus at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis.
    id
    FG002
    title
    Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2
  4. description
    "Participants in all cohorts were administered 20 mg/m\^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Cohort 4: Participants were administered 45 mg/m\^2 of Carfilzomib on days +6 and +7. Participants in all cohorts were administered tacrolimus at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis.
    id
    FG003
    title
    Dose Level 4 - Maximum Dose Carfilzomib 45 mg/m^2
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      comment
      Started carfilzomib
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      comment
      Completed all 4 doses of Carfilzomib
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Phase I: Max Dose 20 mg/m^2 (Day 1-7)
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Phase I: Max Dose 27 mg/m^2 (Day 1-7)
  3. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Phase I: Max Dose 36 mg/m^2 (Day 1-7)
  4. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Phase I: Max Dose 45 mg/m^2 (Day 1-7)
  5. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        37
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        36
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Phase II: Max Dose 36 mg/m^2 (Day 1-7)
pre Assignment Details
Two patients who consented never began treatment.
Complete source fields
groups
  1. description
    Participants in all cohorts were administered 20 mg/m\^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Cohort 1: Participants were administered 20 mg/m\^2 of Carfilzomib on days +6 and +7. Participants in all cohorts were administered tacrolimus at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis.
    id
    FG000
    title
    Dose Level 1 - Maximum Dose Carfilzomib 20 mg/m^2
  2. description
    Participants in all cohorts were administered 20 mg/m\^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Cohort 2: Participants were administered 27 mg/m\^2 of Carfilzomib on days +6 and +7. Participants in all cohorts were administered tacrolimus at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis.
    id
    FG001
    title
    Dose Level 2 - Maximum Dose Carfilzomib 27 mg/m^2
  3. description
    Participants in all cohorts were administered 20 mg/m\^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Cohort 3: Participants were administered 36 mg/m\^2 of Carfilzomib on days +6 and +7. Participants in all cohorts were administered tacrolimus at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis.
    id
    FG002
    title
    Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2
  4. description
    "Participants in all cohorts were administered 20 mg/m\^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Cohort 4: Participants were administered 45 mg/m\^2 of Carfilzomib on days +6 and +7. Participants in all cohorts were administered tacrolimus at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis.
    id
    FG003
    title
    Dose Level 4 - Maximum Dose Carfilzomib 45 mg/m^2
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      comment
      Started carfilzomib
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      comment
      Completed all 4 doses of Carfilzomib
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Phase I: Max Dose 20 mg/m^2 (Day 1-7)
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Phase I: Max Dose 27 mg/m^2 (Day 1-7)
  3. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Phase I: Max Dose 36 mg/m^2 (Day 1-7)
  4. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Phase I: Max Dose 45 mg/m^2 (Day 1-7)
  5. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        37
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        36
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Phase II: Max Dose 36 mg/m^2 (Day 1-7)
pre Assignment Details
Two patients who consented never began treatment.

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

Preserved source evidence · Not medical advice