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NCT03687125 · FLOW

Participant flow

Tinostamustine Conditioning and Autologous Stem Cell · Source last updated 2021-06-18

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

groups
  1. description
    Participants received single dose of tinostamustine 180 milligrams per meter square (mg/m\^2) intravenous (IV) injection on Day -1 followed by autologous stem cell transplantation (ASCT) on Day 1.
    id
    FG000
    title
    Tinostamustine 180 mg/m^2
  2. description
    Participants received single dose of tinostamustine 220 mg/m\^2 IV injection on Day -1 followed by ASCT on Day 1.
    id
    FG001
    title
    Tinostamustine 220 mg/m^2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Progressive Disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Protocol Violation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 6 participants were enrolled and received study drug in Phase 1. Study was early terminated during Phase 1 due to sponsor decision on 17 April 2019 (adverse events limited administration of higher doses required to achieve myeoblative conditioning necessary in this population). Hence, no participants were enrolled in Phase 2 and efficacy analysis were not performed in the both Phase 1 and 2.
recruitment Details
The study was conducted at 3 centers in the United States between 15 October 2018 and 17 April 2019.
Complete source fields
groups
  1. description
    Participants received single dose of tinostamustine 180 milligrams per meter square (mg/m\^2) intravenous (IV) injection on Day -1 followed by autologous stem cell transplantation (ASCT) on Day 1.
    id
    FG000
    title
    Tinostamustine 180 mg/m^2
  2. description
    Participants received single dose of tinostamustine 220 mg/m\^2 IV injection on Day -1 followed by ASCT on Day 1.
    id
    FG001
    title
    Tinostamustine 220 mg/m^2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Progressive Disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Protocol Violation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 6 participants were enrolled and received study drug in Phase 1. Study was early terminated during Phase 1 due to sponsor decision on 17 April 2019 (adverse events limited administration of higher doses required to achieve myeoblative conditioning necessary in this population). Hence, no participants were enrolled in Phase 2 and efficacy analysis were not performed in the both Phase 1 and 2.
recruitment Details
The study was conducted at 3 centers in the United States between 15 October 2018 and 17 April 2019.

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Preserved source evidence · Not medical advice