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NCT00720109 · OUTCOME

Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events

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
Pts with DLTs
Interval / dispersion
Not reported
Time frame
Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1)

What was measured

Number of patients in safety cohort with dose limiting toxicity (DLT)(including treatment delay)

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

Groups in this outcome

Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)

Feasibility measured by DLT rates in safety phase, Toxicities define DLTs and are summarized and reviewed to assess feasibility of administering the combination therapy with dasatinib

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)12

Reported measurements

Source class 1
Values in Pts with DLTs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
Number of patients in safety cohort with dose limiting toxicity (DLT)(including treatment delay)
groups
  1. description
    Feasibility measured by DLT rates in safety phase, Toxicities define DLTs and are summarized and reviewed to assess feasibility of administering the combination therapy with dasatinib
    id
    OG000
    title
    Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)
param Type
NUMBER
population Description
Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL)
reporting Status
POSTED
time Frame
Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1)
title
Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events
type
PRIMARY
unit Of Measure
Pts with DLTs

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

Preserved source evidence · Not medical advice