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NCT00557193 · OUTCOME

Number of Patients Who Experienced Lestaurtinib-related Dose Limiting Toxicity (DLT)

Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia · Source last updated 2024-07-15

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
Up to 12 weeks from start of induction

What was measured

Lestaurtinib-related dose-limiting toxicity proportions, as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, will by summarized by dose level for Safety phase patients.

Analysis population: Arm C patients of Safety Phase who were evaluable for DLT. The first 10 evaluable patients enrolled on each dose level were included for monitoring dose limiting toxicity.

Groups in this outcome

Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib-Dose Level 1)

Evaluable Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at DL1 (HR: 3.5 mg/kg/day; SR: 4 mg/kg/day)

Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib-Dose Level 2)

Evaluable Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at DL2 (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)

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

Analysis denominator · Participants

GroupSource count
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib-Dose Level 1)10
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib-Dose Level 2)10

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib-Dose Level 1)0Not reportedNot reportedNot reportedNot reported
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib-Dose Level 2)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      10
    units
    Participants
description
Lestaurtinib-related dose-limiting toxicity proportions, as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, will by summarized by dose level for Safety phase patients.
groups
  1. description
    Evaluable Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at DL1 (HR: 3.5 mg/kg/day; SR: 4 mg/kg/day)
    id
    OG000
    title
    Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib-Dose Level 1)
  2. description
    Evaluable Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at DL2 (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)
    id
    OG001
    title
    Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib-Dose Level 2)
param Type
COUNT_OF_PARTICIPANTS
population Description
Arm C patients of Safety Phase who were evaluable for DLT. The first 10 evaluable patients enrolled on each dose level were included for monitoring dose limiting toxicity.
reporting Status
POSTED
time Frame
Up to 12 weeks from start of induction
title
Number of Patients Who Experienced Lestaurtinib-related Dose Limiting Toxicity (DLT)
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice