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NCT00106431 · FLOW

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A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL) · Source last updated 2019-10-30

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

groups
  1. description
    Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
    id
    FG000
    title
    Romidepsin
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        102
      type
      STARTED
    2. achievements
      1. comment
        37 represents the number of patients who reached at least 6 months treatment
        group Id
        FG000
        num Subjects
        37
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        65
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Eligible patients were required to have failed at least 1 prior systemic therapy, e.g., interferon, chemotherapy, Ontak® (denileukin diftitox), or Targretin® (bexarotene).
recruitment Details
Patients were enrolled between January 2005 and July 2007. Patients were enrolled at academic centers in the US and Europe that had experience in treating CTCL patients
Complete source fields
groups
  1. description
    Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
    id
    FG000
    title
    Romidepsin
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        102
      type
      STARTED
    2. achievements
      1. comment
        37 represents the number of patients who reached at least 6 months treatment
        group Id
        FG000
        num Subjects
        37
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        65
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Eligible patients were required to have failed at least 1 prior systemic therapy, e.g., interferon, chemotherapy, Ontak® (denileukin diftitox), or Targretin® (bexarotene).
recruitment Details
Patients were enrolled between January 2005 and July 2007. Patients were enrolled at academic centers in the US and Europe that had experience in treating CTCL patients

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice