Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01885897 · OUTCOME

Number of Participants With Dose Limiting Toxicity (DLT) Events

IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic SCT · Source last updated 2020-08-12

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
4 weeks

What was measured

The Dose Limiting Toxicity (DLT) is defined as (during first treatment cycle only): * any treatment-emergent grade 3 non-hematologic toxicity lasting more than 48 hours (refer to section 6.2.1.1 for full definition) * any treatment-emergent grade 4 or 5 non-hematologic toxicity of any duration * grade III or IV acute GVHD within 6 weeks after the first ALT-803 dose Maximum Tolerated Dose (MTD) is defined as the dose level where ≤ 1 out of 6 patients has DLT during the first treatment cycle

Groups in this outcome

ALT-803, IV, 1 mcg/kg

Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.

ALT-803, IV, 3 mcg/kg

Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.

ALT-803, IV, 6 mcg/kg

Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.

ALT-803, IV, 10 mcg/kg

Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.

ALT-803, SQ, 6 mcg/kg

Weekly dose of ALT-803 at assigned dose subcutaneously, once a week for 4 weeks.

ALT-803, SQ, 10 mcg/kg

Weekly dose of ALT-803 at assigned dose , subcutaneously, once a week for 4 weeks.

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

Analysis denominator · Participants

GroupSource count
ALT-803, IV, 1 mcg/kg6
ALT-803, IV, 3 mcg/kg3
ALT-803, IV, 6 mcg/kg4
ALT-803, IV, 10 mcg/kg3
ALT-803, SQ, 6 mcg/kg8
ALT-803, SQ, 10 mcg/kg9

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ALT-803, IV, 1 mcg/kg0Not reportedNot reportedNot reportedNot reported
ALT-803, IV, 3 mcg/kg0Not reportedNot reportedNot reportedNot reported
ALT-803, IV, 6 mcg/kg0Not reportedNot reportedNot reportedNot reported
ALT-803, IV, 10 mcg/kg0Not reportedNot reportedNot reportedNot reported
ALT-803, SQ, 6 mcg/kg0Not reportedNot reportedNot reportedNot reported
ALT-803, SQ, 10 mcg/kg0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      8
    6. group Id
      OG005
      value
      9
    units
    Participants
description
The Dose Limiting Toxicity (DLT) is defined as (during first treatment cycle only): * any treatment-emergent grade 3 non-hematologic toxicity lasting more than 48 hours (refer to section 6.2.1.1 for full definition) * any treatment-emergent grade 4 or 5 non-hematologic toxicity of any duration * grade III or IV acute GVHD within 6 weeks after the first ALT-803 dose Maximum Tolerated Dose (MTD) is defined as the dose level where ≤ 1 out of 6 patients has DLT during the first treatment cycle
groups
  1. description
    Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
    id
    OG000
    title
    ALT-803, IV, 1 mcg/kg
  2. description
    Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
    id
    OG001
    title
    ALT-803, IV, 3 mcg/kg
  3. description
    Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
    id
    OG002
    title
    ALT-803, IV, 6 mcg/kg
  4. description
    Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
    id
    OG003
    title
    ALT-803, IV, 10 mcg/kg
  5. description
    Weekly dose of ALT-803 at assigned dose subcutaneously, once a week for 4 weeks.
    id
    OG004
    title
    ALT-803, SQ, 6 mcg/kg
  6. description
    Weekly dose of ALT-803 at assigned dose , subcutaneously, once a week for 4 weeks.
    id
    OG005
    title
    ALT-803, SQ, 10 mcg/kg
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
4 weeks
title
Number of Participants With Dose Limiting Toxicity (DLT) Events
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice