Participant flow

Myeloablative Haploidentical BMT With Post-transplant Cyclophosphamide for Pediatric Patients With Hematologic Malignancies · Source last updated 2021-11-26

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

groups

1. description

   Patients with acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS): Days -6 through -3: Busulfan q 5-6h IV q24h x 4 days Days -2 and -1: Cyclophosphamide 50mg/kg/day IV x 2 days+ Mesna 40 mg/kg/day IV For patients with acute lymphocytic leukemia (ALL) and lymphoblastic lymphoma: Days -5 through -4: Cyclophosphamide 50mg/kg/day IV q24h x 2 days+Mesna 40 mg/kg/day IV Days -3 through -1: total body irradiation (TBI) 200 Centigray (cGy) twice a day for 3 days All patients Day 0: Infuse unmanipulated bone marrow Day +3 and +4: Cyclophosphamide 50 mg/kg/day IV + Mesna 40 mg/kg IBW/day IV Day +5: Begin tacrolimus 0.015mg/kg IBW/dose IV over 4 hours q 12h and mycophenolate mofetil (MMF)15mg/kg po/IV tid with maximum daily dose 3 gm/day Day +30: Assess chimerism and disease status in bone marrow Day +35: Discontinue MMF Day +60: Assess chimerism and disease status in bone marrow Day 180: Discontinue tacrolimus Cyclophosphamide: Chemotherapy administration TBI: Radiation Therapy Busulfan: Chemotherapy Administered Unmanipulated Bone Marrow: Bone Marrow Transplant Tacrolimus: Immunosuppressive Drug Administered Mycophenolate mofetil: Immunosuppressive Drug Administered

   id

   FG000

   title

   Haploidentical BMT With PTCy for Acute Leukemias and MDS

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         8

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         32

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         30

      type

      Completed 180 Days

   3. achievements

      1. group Id

         FG000

         num Subjects

         24

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         8

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Three patients screen failed due to: One patient could not report on whether the marrow is cellular or at least 20 percent cellularity, one patient had poor liver function, and the one patient's Alanine aminotransferase (ALT) was over the study limit.

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Preserved source evidence · Not medical advice