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NCT00398047 · FLOW

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Azacitidine, Darbepoetin Alfa, and Erythropoietin and Filgastrim (G-CSF) in Treating Patients With Myelodysplastic Syndromes · Source last updated 2018-09-06

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

groups
  1. description
    azacitidine 100 miligrams/meter squares subcutaneous for 5 days every 28 day cycle,o If the patient had a major hematological improvement; or the patient had grade 3 or 4 hematological toxicities during the first two cycles, and/or there is \>=50% reduction in bone marrow cellularity compared to the baseline bone marrow, filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogram) subcutaneous three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8. Patients not meeting the above criteria will have a dose escalation of azacitidine to 125 miligrams/meter subcutaneous for 5 days, beginning on day 57 with growth factor support and filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogra,) sq three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8).
    id
    FG000
    title
    Combination of Azacitadine and Hematopoietic Growth Factors
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      all patient progressed before completion
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. comment
        all three patients progressed before completing
        group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Three patients were enrolled between 09/14/06 and 01/07/2008. The study was closed for slow accrual on 09/02/2009.
Complete source fields
groups
  1. description
    azacitidine 100 miligrams/meter squares subcutaneous for 5 days every 28 day cycle,o If the patient had a major hematological improvement; or the patient had grade 3 or 4 hematological toxicities during the first two cycles, and/or there is \>=50% reduction in bone marrow cellularity compared to the baseline bone marrow, filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogram) subcutaneous three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8. Patients not meeting the above criteria will have a dose escalation of azacitidine to 125 miligrams/meter subcutaneous for 5 days, beginning on day 57 with growth factor support and filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogra,) sq three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8).
    id
    FG000
    title
    Combination of Azacitadine and Hematopoietic Growth Factors
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      all patient progressed before completion
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. comment
        all three patients progressed before completing
        group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Three patients were enrolled between 09/14/06 and 01/07/2008. The study was closed for slow accrual on 09/02/2009.

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Preserved source evidence · Not medical advice