Skip to content
← Full study record

NCT02169791 · FLOW

Participant flow

Nonmyeloablative Haploidentical Transplant Followed by MLN9708 · Source last updated 2021-09-02

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

groups
  1. description
    All patients will receive a haploidentical donor transplant using a conditioning regimen of Fludarabine (Flu), cyclophosphamide (cy) and total body irradiation (TBI) followed by MLN9708. MLN9708: MLN9708 will be given weekly x 3 weeks every 28 day cycles, for up to 12 cycles starting at D+5 post-transplant.
    id
    FG000
    title
    Haploidentical Transplant
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      patient withdrew consent
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        25
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        18
      comment
      18 patients completed the full study including follow up.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
This was a single arm study with no assignment groups. If patients met criteria they were considered for the study. 29 patients were consented and 25 of those patients were deemed eligible to participate. 4 patients were considered screen failures.
recruitment Details
This study was opened at our site 7/15/2014 and closed to accrual on 8/28/18. Patients were recruited internally and were considered if they were undergoing a haploidentical transplant for a high risk malignancy.
Complete source fields
groups
  1. description
    All patients will receive a haploidentical donor transplant using a conditioning regimen of Fludarabine (Flu), cyclophosphamide (cy) and total body irradiation (TBI) followed by MLN9708. MLN9708: MLN9708 will be given weekly x 3 weeks every 28 day cycles, for up to 12 cycles starting at D+5 post-transplant.
    id
    FG000
    title
    Haploidentical Transplant
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      patient withdrew consent
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        25
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        18
      comment
      18 patients completed the full study including follow up.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
This was a single arm study with no assignment groups. If patients met criteria they were considered for the study. 29 patients were consented and 25 of those patients were deemed eligible to participate. 4 patients were considered screen failures.
recruitment Details
This study was opened at our site 7/15/2014 and closed to accrual on 8/28/18. Patients were recruited internally and were considered if they were undergoing a haploidentical transplant for a high risk malignancy.

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

Preserved source evidence · Not medical advice