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NCT02120157 · OUTCOME

Survival

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
percent
Interval / dispersion
Not reported
Time frame
up to 2 years

What was measured

Estimate incidence of overall survival (OS), progression-free survival (PFS), disease-free survival (DFS), event-free survival, and relapse-free GVHD-free survival (GRFS) in patients receiving myeloablative, HLA-mismatched BMT for patients with high risk hematologic malignancies at 2 years. Incidence as a percentage.

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 MDS32

Reported measurements

overall survival (OS)
Values in percent · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Haploidentical BMT With PTCy for Acute Leukemias and MDS73Not reportedNot reportedNot reportedNot reported
progression-free survival (PFS)
Values in percent · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Haploidentical BMT With PTCy for Acute Leukemias and MDS64Not reportedNot reportedNot reportedNot reported
disease-free survival (DFS)
Values in percent · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Haploidentical BMT With PTCy for Acute Leukemias and MDS64Not reportedNot reportedNot reportedNot reported
event-free survival
Values in percent · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Haploidentical BMT With PTCy for Acute Leukemias and MDS64Not reportedNot reportedNot reportedNot reported
Relapse-free GVHD-free survival (GRFS)
Values in percent · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Haploidentical BMT With PTCy for Acute Leukemias and MDS52Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        73
    title
    overall survival (OS)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        64
    title
    progression-free survival (PFS)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        64
    title
    disease-free survival (DFS)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        64
    title
    event-free survival
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        52
    title
    Relapse-free GVHD-free survival (GRFS)
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    units
    Participants
description
Estimate incidence of overall survival (OS), progression-free survival (PFS), disease-free survival (DFS), event-free survival, and relapse-free GVHD-free survival (GRFS) in patients receiving myeloablative, HLA-mismatched BMT for patients with high risk hematologic malignancies at 2 years. Incidence as a percentage.
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
reporting Status
POSTED
time Frame
up to 2 years
title
Survival
type
SECONDARY
unit Of Measure
percent

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

Preserved source evidence · Not medical advice