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NCT03225716 · OUTCOME

Maximum Tolerated Dose (MTD) of Ulocuplumab

A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom's Macroglobulinemia · Source last updated 2024-05-03

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

Measure
NUMBER
Unit
milligram
Interval / dispersion
Not reported
Time frame
Up to 8 weeks for each dose level

What was measured

MTD was determined by testing increasing doses up to 1600mg of ulocuplumab on dose escalation levels 1 to 3 with 3 to 7 participants each. MTD reflects the highest dose of ulocuplumab that did not cause a Dose-Limiting Toxicity (DLT) in \>33% of participants. DLTs were defined as any Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0) grade 4 or 5 hematologic toxicities (anemia, neutropenia, or thrombocytopenia) and grade 3 or above non-hematologic toxicities. Exceptions were allowed for toxicities attributed to underlying disease, grade 3 infection, and easily reversible asymptomatic laboratory abnormalities, and nausea, vomiting, or diarrhea controlled by medications.

Groups in this outcome

All Participants

All participants who received at least 1 dose of Ulocuplumab, either at 400mg for cycle 1 and 800mg for cycle 2+, 800mg for cycle 1 and 1200mg for cycle 2+, or 800mg for cycle 1 and 1600mg for cycle 2+

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 Participants13

Reported measurements

Source class 1
Values in milligram · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants1600Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1600
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
MTD was determined by testing increasing doses up to 1600mg of ulocuplumab on dose escalation levels 1 to 3 with 3 to 7 participants each. MTD reflects the highest dose of ulocuplumab that did not cause a Dose-Limiting Toxicity (DLT) in \>33% of participants. DLTs were defined as any Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0) grade 4 or 5 hematologic toxicities (anemia, neutropenia, or thrombocytopenia) and grade 3 or above non-hematologic toxicities. Exceptions were allowed for toxicities attributed to underlying disease, grade 3 infection, and easily reversible asymptomatic laboratory abnormalities, and nausea, vomiting, or diarrhea controlled by medications.
groups
  1. description
    All participants who received at least 1 dose of Ulocuplumab, either at 400mg for cycle 1 and 800mg for cycle 2+, 800mg for cycle 1 and 1200mg for cycle 2+, or 800mg for cycle 1 and 1600mg for cycle 2+
    id
    OG000
    title
    All Participants
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 8 weeks for each dose level
title
Maximum Tolerated Dose (MTD) of Ulocuplumab
type
PRIMARY
unit Of Measure
milligram

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

Preserved source evidence · Not medical advice