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NCT03674411 · OUTCOME

Treatment Related Mortality (TRM)

Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy · Source last updated 2026-01-06

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
6 Months

What was measured

Incidence of TRM at 6 months

Groups in this outcome

FLU, CY, TBI + MGTA-456 Infusion

All patients aged 3-55 years will be conditioned with cyclophosphamide (CY) 120 mg/kg total dose, fludarabine (FLU) 75 m/m2 total dose and total body irradiation (TBI) 1320 cGy total dose as well as tacrolimus (Tac) and mycophenolate mofetil (MMF) immunoprophylaxis and granulocyte-colony stimulating factor (G-CSF)

BU,FLU, MEL + MGTA-456 Infusion

All young children \<3 years of age at the time of diagnosis will receive MGTA-456 on the day of transplantation after a non-TBI containing myeloablative conditioning as TBI may have a damaging effect on brain development in the very young child. All patients aged 0-3 years will be conditioned with busulfan (BU), FLU and melphalan (MEL) as well as Tac/MMF immunoprophylaxis and G-CSF

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

Analysis denominator · Participants

GroupSource count
FLU, CY, TBI + MGTA-456 Infusion16
BU,FLU, MEL + MGTA-456 Infusion2

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
FLU, CY, TBI + MGTA-456 Infusion6Not reported018Not reported
BU,FLU, MEL + MGTA-456 Infusion50Not reported1585Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        18
        value
        6
      2. group Id
        OG001
        lower Limit
        15
        upper Limit
        85
        value
        50
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    2. group Id
      OG001
      value
      2
    units
    Participants
description
Incidence of TRM at 6 months
dispersion Type
95% Confidence Interval
groups
  1. description
    All patients aged 3-55 years will be conditioned with cyclophosphamide (CY) 120 mg/kg total dose, fludarabine (FLU) 75 m/m2 total dose and total body irradiation (TBI) 1320 cGy total dose as well as tacrolimus (Tac) and mycophenolate mofetil (MMF) immunoprophylaxis and granulocyte-colony stimulating factor (G-CSF)
    id
    OG000
    title
    FLU, CY, TBI + MGTA-456 Infusion
  2. description
    All young children \<3 years of age at the time of diagnosis will receive MGTA-456 on the day of transplantation after a non-TBI containing myeloablative conditioning as TBI may have a damaging effect on brain development in the very young child. All patients aged 0-3 years will be conditioned with busulfan (BU), FLU and melphalan (MEL) as well as Tac/MMF immunoprophylaxis and G-CSF
    id
    OG001
    title
    BU,FLU, MEL + MGTA-456 Infusion
param Type
NUMBER
reporting Status
POSTED
time Frame
6 Months
title
Treatment Related Mortality (TRM)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice