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NCT00364923 · FLOW

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Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma · Source last updated 2019-12-19

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

groups
  1. description
    All patients who received at least one dose of pralatrexate. Patients continued pralatrexate until protocol defined criteria for discontinuation or 24 months of treatment.
    id
    FG000
    title
    Full Population
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Treatment with pralatrexate ongoing
    milestones
    1. achievements
      1. comment
        Received at least one dose of pralatrexate.
        group Id
        FG000
        num Subjects
        111
      type
      STARTED
    2. achievements
      1. comment
        Treatment duration not limited. After treatment ends, patients attend survival follow-up visits.
        group Id
        FG000
        num Subjects
        107
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Treatment With Pralatrexate
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        24
      type
      Pts still in follow-up at data cutoff
    milestones
    1. achievements
      1. comment
        Patients (pts) who stop treatment with pralatrexate are followed for survival
        group Id
        FG000
        num Subjects
        107
      type
      STARTED
    2. achievements
      1. comment
        Pts who completed follow-up either died, were followed for 24 months, or withdrew
        group Id
        FG000
        num Subjects
        83
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Survival Follow-up, After Pralatrexate
pre Assignment Details
Patients (pts) were required to have at least 10 days of vitamin supplementation during the up to 12 days between enrollment \& dosing. Four of the 115 pts enrolled were excluded during this period: 2 did not have an eligible PTCL subtype per central review, 1 had the presence of B-cell lymphoma per the investigator, 1 had progressive disease.
recruitment Details
Patients were enrolled between 24 August 2006 and 14 April 2008 across 25 study sites, 15 sites in the United States (US), 8 in Europe, and 2 in Canada.
Complete source fields
groups
  1. description
    All patients who received at least one dose of pralatrexate. Patients continued pralatrexate until protocol defined criteria for discontinuation or 24 months of treatment.
    id
    FG000
    title
    Full Population
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Treatment with pralatrexate ongoing
    milestones
    1. achievements
      1. comment
        Received at least one dose of pralatrexate.
        group Id
        FG000
        num Subjects
        111
      type
      STARTED
    2. achievements
      1. comment
        Treatment duration not limited. After treatment ends, patients attend survival follow-up visits.
        group Id
        FG000
        num Subjects
        107
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Treatment With Pralatrexate
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        24
      type
      Pts still in follow-up at data cutoff
    milestones
    1. achievements
      1. comment
        Patients (pts) who stop treatment with pralatrexate are followed for survival
        group Id
        FG000
        num Subjects
        107
      type
      STARTED
    2. achievements
      1. comment
        Pts who completed follow-up either died, were followed for 24 months, or withdrew
        group Id
        FG000
        num Subjects
        83
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Survival Follow-up, After Pralatrexate
pre Assignment Details
Patients (pts) were required to have at least 10 days of vitamin supplementation during the up to 12 days between enrollment \& dosing. Four of the 115 pts enrolled were excluded during this period: 2 did not have an eligible PTCL subtype per central review, 1 had the presence of B-cell lymphoma per the investigator, 1 had progressive disease.
recruitment Details
Patients were enrolled between 24 August 2006 and 14 April 2008 across 25 study sites, 15 sites in the United States (US), 8 in Europe, and 2 in Canada.

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Preserved source evidence · Not medical advice