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NCT03905135 · OUTCOME

Maximum Tolerated Dose (MTD) of Interleukin 15

Interleukin-15 (IL-5) in Combination With Avelumab (Bavencio) in Relapsed/Refractory Mature T-cell Malignancies · Source last updated 2022-09-13

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
First 28 days of treatment

What was measured

The MTD is the dose level at which no more than 1 of up to 6 participants experience a dose-limiting toxicity (DLT) during the DLT evaluation window(s), or the dose below that at which at least 2 (of ≤6) participants have DLT. A dose-limiting toxicity (DLT) is defined as: any grade 3, 4, or 5 toxicity, if not incontrovertibly due to disease progression or an extraneous cause, and deemed possibly, probably or definitely related to interleukin-15 (IL-5) by the principal investigator (PI) or designee during the first 28 days of treatment. Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event.

Groups in this outcome

Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab

Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles.

Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab

Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles.

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

Analysis denominator · Participants

GroupSource count
Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab6
Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab2

Reported measurements

Source class 1
Values in mcg/kg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg AvelumabNANot reportedNot reportedNot reportedThe MTD was not found because the study was halted due to manufacturer withdrawal of support for low enrollment.
Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg AvelumabNANot reportedNot reportedNot reportedThe MTD was not found because the study was halted due to manufacturer withdrawal of support for low enrollment.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The MTD was not found because the study was halted due to manufacturer withdrawal of support for low enrollment.
        group Id
        OG000
        value
        NA
      2. comment
        The MTD was not found because the study was halted due to manufacturer withdrawal of support for low enrollment.
        group Id
        OG001
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      2
    units
    Participants
description
The MTD is the dose level at which no more than 1 of up to 6 participants experience a dose-limiting toxicity (DLT) during the DLT evaluation window(s), or the dose below that at which at least 2 (of ≤6) participants have DLT. A dose-limiting toxicity (DLT) is defined as: any grade 3, 4, or 5 toxicity, if not incontrovertibly due to disease progression or an extraneous cause, and deemed possibly, probably or definitely related to interleukin-15 (IL-5) by the principal investigator (PI) or designee during the first 28 days of treatment. Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event.
groups
  1. description
    Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles.
    id
    OG000
    title
    Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab
  2. description
    Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles.
    id
    OG001
    title
    Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab
param Type
NUMBER
reporting Status
POSTED
time Frame
First 28 days of treatment
title
Maximum Tolerated Dose (MTD) of Interleukin 15
type
PRIMARY
unit Of Measure
mcg/kg

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

Preserved source evidence · Not medical advice