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NCT03805932 · OUTCOME

Recommended Safe Dose of Moxetumomab Pasudotox-tdfk

Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia · Source last updated 2026-06-29

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

Measure
NUMBER
Unit
mcg/kg
Interval / dispersion
Not reported
Time frame
4 weeks

What was measured

Recommended safe dose of moxetumomab pasudotox-tdfk is defined as the treatment of 10 participants with no more than 2 experiencing a dose-limiting toxicity (DLT). A DLT is defined as all treatment related Grade 3-5 adverse events (AEs) occurring from the initiation of moxetumomab pasudotox-tdfk therapy to within 30 days after the last dose of moxetumomab pasudotox-tdfk treatment assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event.

Groups in this outcome

All Participants

All participants in Group 1 and Group 2 who received at least one dose of Moxetumomab 30-40 mcg/kg.

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

Analysis denominator · Participants

GroupSource count
All Participants18

Reported measurements

Source class 1
Values in mcg/kg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants40Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        40
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
Recommended safe dose of moxetumomab pasudotox-tdfk is defined as the treatment of 10 participants with no more than 2 experiencing a dose-limiting toxicity (DLT). A DLT is defined as all treatment related Grade 3-5 adverse events (AEs) occurring from the initiation of moxetumomab pasudotox-tdfk therapy to within 30 days after the last dose of moxetumomab pasudotox-tdfk treatment assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event.
groups
  1. description
    All participants in Group 1 and Group 2 who received at least one dose of Moxetumomab 30-40 mcg/kg.
    id
    OG000
    title
    All Participants
param Type
NUMBER
reporting Status
POSTED
time Frame
4 weeks
title
Recommended Safe Dose of Moxetumomab Pasudotox-tdfk
type
PRIMARY
unit Of Measure
mcg/kg

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

Preserved source evidence · Not medical advice