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NCT00720109 · OUTCOME

Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy

Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia · Source last updated 2020-04-13

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
At 3 years

What was measured

Event-Free Survival (EFS) curves will be constructed using the Kaplan-Meier life table method with standard errors computed using the method of Peto and Peto. A 1-sided 95% confidence interval for EFS will be constructed.

Analysis population: Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).

Groups in this outcome

Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)

See Detailed Description Asparaginase: Given IT Cyclophosphamide: Given IV Cytarabine: Given IT or IV Dasatinib: Given PO Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Hydrocortisone Sodium Succinate: Given IT Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV or PO Mercaptopurine: Given PO Methotrexate: Given IT, PO, or IV Methylprednisolone: Given IV Pegaspargase: Given IM Prednisone: Given PO or IV Radiation Therapy: Some patients undergo cranial RT Vincristine Sulfate: Given IV

Standard-risk

Based on Minimal Residual Disease, less than 1%.

High-risk

Based on Minimal Residual Disease, great than or equal to 1%.

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

Analysis denominator · Participants

GroupSource count
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)60
Standard-risk48
High-risk9

Reported measurements

Source class 1
Values in Percent probability · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)79.8Not reported71.188.5Not reported
Standard-risk83.2Not reported74.192.2Not reported
High-risk66.7Not reported40.992.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        71.1
        upper Limit
        88.5
        value
        79.8
      2. group Id
        OG001
        lower Limit
        74.1
        upper Limit
        92.2
        value
        83.2
      3. group Id
        OG002
        lower Limit
        40.9
        upper Limit
        92.5
        value
        66.7
denoms
  1. counts
    1. group Id
      OG000
      value
      60
    2. group Id
      OG001
      value
      48
    3. group Id
      OG002
      value
      9
    units
    Participants
description
Event-Free Survival (EFS) curves will be constructed using the Kaplan-Meier life table method with standard errors computed using the method of Peto and Peto. A 1-sided 95% confidence interval for EFS will be constructed.
dispersion Type
90% Confidence Interval
groups
  1. description
    See Detailed Description Asparaginase: Given IT Cyclophosphamide: Given IV Cytarabine: Given IT or IV Dasatinib: Given PO Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Hydrocortisone Sodium Succinate: Given IT Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV or PO Mercaptopurine: Given PO Methotrexate: Given IT, PO, or IV Methylprednisolone: Given IV Pegaspargase: Given IM Prednisone: Given PO or IV Radiation Therapy: Some patients undergo cranial RT Vincristine Sulfate: Given IV
    id
    OG000
    title
    Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)
  2. description
    Based on Minimal Residual Disease, less than 1%.
    id
    OG001
    title
    Standard-risk
  3. description
    Based on Minimal Residual Disease, great than or equal to 1%.
    id
    OG002
    title
    High-risk
param Type
NUMBER
population Description
Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).
reporting Status
POSTED
time Frame
At 3 years
title
Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy
type
PRIMARY
unit Of Measure
Percent probability

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

Preserved source evidence · Not medical advice