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NCT00137111 · OUTCOME

Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours).

Therapy for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia · Source last updated 2020-09-11

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

Measure
MEAN
Unit
pmol/1,000,000,000 cells
Interval / dispersion
Standard Deviation
Time frame
42 hours after start of high dose methotrexate infusion (HDMTX)

What was measured

Children were randomly assigned to receive initial single-agent treatment with HDMTX (1g/m\^2) as either a 24-hour infusion or a 4-hour infusion and the outcome measure was the accumulation of MTXPG in leukemia cells.

Analysis population: The 286 patients randomized to treatment with high-dose methotrexate (HDMTX) who had methotrexate polyglutamate (MTXPG) concentration measured in bone marrow ALL cells .

Groups in this outcome

4 hr

4 hour High-Dose Methotrexate Infusion in upfront window treatment

24 hr

24 hour High-Dose Methotrexate Infusion in upfront window treatment

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

Analysis denominator · Participants

GroupSource count
4 hr136
24 hr150

Reported measurements

Source class 1
Values in pmol/1,000,000,000 cells · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
4 hr16882015Not reportedNot reportedNot reported
24 hr25212950Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    t-test stratified for lineage and ploidy
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    .0062
    p Value Comment
    p-value from t-test after stratified for lineage and ploidy
    statistical Method
    t-test, 2 sided
Complete source fields
analyses
  1. group Description
    t-test stratified for lineage and ploidy
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    .0062
    p Value Comment
    p-value from t-test after stratified for lineage and ploidy
    statistical Method
    t-test, 2 sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2015
        value
        1688
      2. group Id
        OG001
        spread
        2950
        value
        2521
denoms
  1. counts
    1. group Id
      OG000
      value
      136
    2. group Id
      OG001
      value
      150
    units
    Participants
description
Children were randomly assigned to receive initial single-agent treatment with HDMTX (1g/m\^2) as either a 24-hour infusion or a 4-hour infusion and the outcome measure was the accumulation of MTXPG in leukemia cells.
dispersion Type
Standard Deviation
groups
  1. description
    4 hour High-Dose Methotrexate Infusion in upfront window treatment
    id
    OG000
    title
    4 hr
  2. description
    24 hour High-Dose Methotrexate Infusion in upfront window treatment
    id
    OG001
    title
    24 hr
param Type
MEAN
population Description
The 286 patients randomized to treatment with high-dose methotrexate (HDMTX) who had methotrexate polyglutamate (MTXPG) concentration measured in bone marrow ALL cells .
reporting Status
POSTED
time Frame
42 hours after start of high dose methotrexate infusion (HDMTX)
title
Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours).
type
SECONDARY
unit Of Measure
pmol/1,000,000,000 cells

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

Preserved source evidence · Not medical advice