Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00557193 · OUTCOME

Identification of Gene Expression Patterns in Diagnostic Infant Leukemia Samples That Correlate With PIA Values

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
At 3 years

What was measured

Means and standard deviations of Plasma Inhibitory Activity (PIA) will be given by genotype

Analysis population: Data was and never will be collected

Groups in this outcome

Arm A (Standard Risk MLL-G)

Population Description: Eligible patients with MLL-G (germline, or non-rearranged) Asparaginase: Given IV, IM, or PO Cyclophosphamide: Given IV Cytarabine: Given IV or IT Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IV, IT, or PO Methylprednisolone: Given IV Pegaspargase: Given IM Pharmacological Study: Correlative studies Prednisone: Given PO Therapeutic Hydrocortisone: Given IT Vincristine Sulfate: Given IV

Arm B (IR/HR MLL-R Chemotherapy)

Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \>= 90 days at diagnosis and High Risk (HR) if age \< 90 days at diagnosis. Asparaginase: Given IV, IM, or PO Cyclophosphamide: Given IV Cytarabine: Given IV or IT Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IV, IT, or PO Methylprednisolone: Given IV Pegaspargase: Given IM Pharmacological Study: Correlative studies Prednisone: Given PO Therapeutic Hydrocortisone: Given IT Vincristine Sulfate: Given IV

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

Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \>= 90 days at diagnosis and High Risk (HR) if age \< 90 days at diagnosis. Asparaginase: Given IV, IM, or PO Cyclophosphamide: Given IV Cytarabine: Given IV or IT Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Laboratory Biomarker Analysis: Correlative studies Lestaurtinib: Given PO Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IV, IT, or PO Methylprednisolone: Given IV Pegaspargase: Given IM Pharmacological Study: Correlative studies Prednisone: Given PO Therapeutic Hydrocortisone: Given IT Vincristine Sulfate: Given IV

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 A (Standard Risk MLL-G)0
Arm B (IR/HR MLL-R Chemotherapy)0
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    units
    Participants
description
Means and standard deviations of Plasma Inhibitory Activity (PIA) will be given by genotype
groups
  1. description
    Population Description: Eligible patients with MLL-G (germline, or non-rearranged) Asparaginase: Given IV, IM, or PO Cyclophosphamide: Given IV Cytarabine: Given IV or IT Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IV, IT, or PO Methylprednisolone: Given IV Pegaspargase: Given IM Pharmacological Study: Correlative studies Prednisone: Given PO Therapeutic Hydrocortisone: Given IT Vincristine Sulfate: Given IV
    id
    OG000
    title
    Arm A (Standard Risk MLL-G)
  2. description
    Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \>= 90 days at diagnosis and High Risk (HR) if age \< 90 days at diagnosis. Asparaginase: Given IV, IM, or PO Cyclophosphamide: Given IV Cytarabine: Given IV or IT Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IV, IT, or PO Methylprednisolone: Given IV Pegaspargase: Given IM Pharmacological Study: Correlative studies Prednisone: Given PO Therapeutic Hydrocortisone: Given IT Vincristine Sulfate: Given IV
    id
    OG001
    title
    Arm B (IR/HR MLL-R Chemotherapy)
  3. description
    Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \>= 90 days at diagnosis and High Risk (HR) if age \< 90 days at diagnosis. Asparaginase: Given IV, IM, or PO Cyclophosphamide: Given IV Cytarabine: Given IV or IT Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Laboratory Biomarker Analysis: Correlative studies Lestaurtinib: Given PO Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IV, IT, or PO Methylprednisolone: Given IV Pegaspargase: Given IM Pharmacological Study: Correlative studies Prednisone: Given PO Therapeutic Hydrocortisone: Given IT Vincristine Sulfate: Given IV
    id
    OG002
    title
    Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)
population Description
Data was and never will be collected
reporting Status
POSTED
time Frame
At 3 years
title
Identification of Gene Expression Patterns in Diagnostic Infant Leukemia Samples That Correlate With PIA Values
type
SECONDARY

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

Preserved source evidence · Not medical advice