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NCT02120157 · OUTCOME

Steroid and Non-steroid Immunosuppressants Use Duration

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.

Measure
NUMBER
Unit
months
Interval / dispersion
Not reported
Time frame
Two Years

What was measured

Duration of use of steroid and non-steroid immunosuppressants (in months) to treat GVHD.

Analysis population: Four participants used immunosuppressants. Four used steroids and 2 of the 4 also used non-steroid. Duration of use for 3 participants using steroids was not recorded. One participant using non-steroid was not recorded.

Groups in this outcome

Haploidentical BMT With PTCy for Acute Leukemias and MDS

Patients with AML and 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 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: 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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Haploidentical BMT With PTCy for Acute Leukemias and MDS2

Reported measurements

Steroid immunosuppressants

Analysis denominator · Participants

GroupSource count
Haploidentical BMT With PTCy for Acute Leukemias and MDS1
Values in months · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Haploidentical BMT With PTCy for Acute Leukemias and MDS18Not reportedNot reportedNot reportedNot reported
Non-steroid immunosuppressants

Analysis denominator · Participants

GroupSource count
Haploidentical BMT With PTCy for Acute Leukemias and MDS1
Values in months · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Haploidentical BMT With PTCy for Acute Leukemias and MDS19Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Steroid immunosuppressants
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        19
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Non-steroid immunosuppressants
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
Duration of use of steroid and non-steroid immunosuppressants (in months) to treat GVHD.
groups
  1. description
    Patients with AML and 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 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: 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
    OG000
    title
    Haploidentical BMT With PTCy for Acute Leukemias and MDS
param Type
NUMBER
population Description
Four participants used immunosuppressants. Four used steroids and 2 of the 4 also used non-steroid. Duration of use for 3 participants using steroids was not recorded. One participant using non-steroid was not recorded.
reporting Status
POSTED
time Frame
Two Years
title
Steroid and Non-steroid Immunosuppressants Use Duration
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice