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NCT00462605 · FLOW

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MS-275 and GM-CSF in Treating Patients With Myelodysplastic Syndrome and/or Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphocytic Leukemia · Source last updated 2017-07-18

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

groups
  1. description
    Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria. entinostat: Given PO sargramostim: Given SC
    id
    FG000
    title
    Arm I
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        14
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria. entinostat: Given PO sargramostim: Given SC
    id
    FG000
    title
    Arm I
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        14
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice