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NCT03159702 · FLOW

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Propylene Glycol-Free Melphalan HCl (EVOMELA®) in Combination With Fludarabine and Total Body Irradiation Based Reduced Intensity Conditioning for Haploidentical Transplantation · Source last updated 2026-01-27

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

groups
  1. description
    For patients who are \< 60 years. * Melphalan: 140 mg/m2/day IV on Day: -6 * Fludarabine: 40 mg/ m2/day IV Days: -5 -4, -3, -2 (Adults: creatinine clearance (CrCl) may be estimated by the Cockcroft Formula: CrCl = \[(140-age) x weight (kg) x 0.85 (for women only)\]/ \[72 x creat (mg/dl)\].) * TBI: 200 cGy Day: -1. For patients who are ≥60 years and/or Hematopoietic Cell Transplant-Co-morbidity Index (HCT-CI) score of \>3 (at the discretion of treating physician will have an option to receive): * Melphalan: 70 mg/m2/day IV on Day -6. * Fludarabine: 40 mg/m2/day IV Days -5, -4, -3, -2. * TBI: 200 cGy; Days -1. Evomela: 140 mg/m\^2/day IV on Day -6 for patients who are \< 60 years of age. 70 mg/m\^2/day IV on Day -6 For patients who are ≥60 years or have a HCT-CI score of \>3 Fludarabine: 40 mg/ m\^2/day intravenous on Days: -5 -4, -3, -2 Total Body Irradiation: 200 cGy on Day: -1
    id
    FG000
    title
    MEL/FLU and Total-Body Irradiation (TBI)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        43
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        43
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    For patients who are \< 60 years. * Melphalan: 140 mg/m2/day IV on Day: -6 * Fludarabine: 40 mg/ m2/day IV Days: -5 -4, -3, -2 (Adults: creatinine clearance (CrCl) may be estimated by the Cockcroft Formula: CrCl = \[(140-age) x weight (kg) x 0.85 (for women only)\]/ \[72 x creat (mg/dl)\].) * TBI: 200 cGy Day: -1. For patients who are ≥60 years and/or Hematopoietic Cell Transplant-Co-morbidity Index (HCT-CI) score of \>3 (at the discretion of treating physician will have an option to receive): * Melphalan: 70 mg/m2/day IV on Day -6. * Fludarabine: 40 mg/m2/day IV Days -5, -4, -3, -2. * TBI: 200 cGy; Days -1. Evomela: 140 mg/m\^2/day IV on Day -6 for patients who are \< 60 years of age. 70 mg/m\^2/day IV on Day -6 For patients who are ≥60 years or have a HCT-CI score of \>3 Fludarabine: 40 mg/ m\^2/day intravenous on Days: -5 -4, -3, -2 Total Body Irradiation: 200 cGy on Day: -1
    id
    FG000
    title
    MEL/FLU and Total-Body Irradiation (TBI)
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        43
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        43
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice