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NCT00557193 · OUTCOME

Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2

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
NUMBER
Unit
percent probability
Interval / dispersion
90% Confidence Interval
Time frame
From start of post-induction therapy for up to 10 years.

What was measured

Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. EFS will be compared between patients on treatment Arm C at DL2 to those on Arm B.

Analysis population: All eligible Arm B and ARM C (Dose Level 2) patients were included in the analysis.

Groups in this outcome

Arm B (IR/HR MLL-R Chemotherapy)

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)

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 B (IR/HR MLL-R Chemotherapy)54
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)67

Reported measurements

Source class 1
Values in percent probability · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm B (IR/HR MLL-R Chemotherapy)38.89Not reported27.9849.80Not reported
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)35.82Not reported25.9845.66Not reported

Source statistical analyses

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

  1. ci Num Sides
    ONE_SIDED
    ci Pct Value
    85
    ci Upper Limit
    1.403
    estimate Comment
    Arm C is the numerator and Arm B is the denominator of the estimated hazard ratio
    group Description
    A one-sided log rank test will be used for testing whether the EFS in Arm C (chemo+lest) at DL2 is greater than the EFS in Arm B (chemo). This is equivalent to testing the null hypothesis of hazard ratio (HR)=1 versus the alternative of HR\<1.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.672
    p Value Comment
    A priori significance level threshold of alpha=0.15
    param Type
    Hazard Ratio (HR)
    param Value
    1.107
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Num Sides
    ONE_SIDED
    ci Pct Value
    85
    ci Upper Limit
    1.403
    estimate Comment
    Arm C is the numerator and Arm B is the denominator of the estimated hazard ratio
    group Description
    A one-sided log rank test will be used for testing whether the EFS in Arm C (chemo+lest) at DL2 is greater than the EFS in Arm B (chemo). This is equivalent to testing the null hypothesis of hazard ratio (HR)=1 versus the alternative of HR\<1.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.672
    p Value Comment
    A priori significance level threshold of alpha=0.15
    param Type
    Hazard Ratio (HR)
    param Value
    1.107
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.98
        upper Limit
        49.80
        value
        38.89
      2. group Id
        OG001
        lower Limit
        25.98
        upper Limit
        45.66
        value
        35.82
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    2. group Id
      OG001
      value
      67
    units
    Participants
description
Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. EFS will be compared between patients on treatment Arm C at DL2 to those on Arm B.
dispersion Type
90% Confidence Interval
groups
  1. 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
    OG000
    title
    Arm B (IR/HR MLL-R Chemotherapy)
  2. 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
    OG001
    title
    Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)
param Type
NUMBER
population Description
All eligible Arm B and ARM C (Dose Level 2) patients were included in the analysis.
reporting Status
POSTED
time Frame
From start of post-induction therapy for up to 10 years.
title
Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2
type
SECONDARY
unit Of Measure
percent probability

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Preserved source evidence · Not medical advice