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NCT01620216 · OUTCOME

Overall Survival

Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia · Source last updated 2021-11-04

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

Measure
MEAN
Unit
Days
Interval / dispersion
Full Range
Time frame
From the date of subject registration to death, regardless of causes of death, assessed up to 3 years

What was measured

Kaplan-Meier method will be used to estimate the survival curve.

Analysis population: Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.

Groups in this outcome

Group I (Dasatinib)

Patients receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Dasatinib: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies

Group II (Sutinib Malate)

Patients receive sutinib malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Sunitinib: Given PO Sunitinib Malate: Given PO

Group III (Sorafenib Tosylate)

Patients receive sorafenib tosylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Sorafenib: Given PO Sorafenib Tosylate: Given PO

Group IV (Ponatinib Hydrochloride)

Patients receive ponatinib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Ponatinib: Given PO Ponatinib Hydrochloride: Given PO

Group V (Pacritinib)

Patients receive pacritinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pacritinib: Given PO Pharmacological Study: Correlative studies

Group VI (Ruxolitinib)

Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Ruxolitinib: Given PO

Group VII (Idelalisib)

Patients receive idelalisib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Idelalisib: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies

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

Analysis denominator · Participants

GroupSource count
Group I (Dasatinib)4
Group II (Sutinib Malate)2
Group III (Sorafenib Tosylate)6
Group IV (Ponatinib Hydrochloride)0
Group V (Pacritinib)0
Group VI (Ruxolitinib)0
Group VII (Idelalisib)0

Reported measurements

Source class 1
Values in Days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Group I (Dasatinib)57Not reported18147Not reported
Group II (Sutinib Malate)75Not reported6144Not reported
Group III (Sorafenib Tosylate)130Not reported43430Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18
        upper Limit
        147
        value
        57
      2. group Id
        OG001
        lower Limit
        6
        upper Limit
        144
        value
        75
      3. group Id
        OG002
        lower Limit
        43
        upper Limit
        430
        value
        130
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    7. group Id
      OG006
      value
      0
    units
    Participants
description
Kaplan-Meier method will be used to estimate the survival curve.
dispersion Type
Full Range
groups
  1. description
    Patients receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Dasatinib: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
    id
    OG000
    title
    Group I (Dasatinib)
  2. description
    Patients receive sutinib malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Sunitinib: Given PO Sunitinib Malate: Given PO
    id
    OG001
    title
    Group II (Sutinib Malate)
  3. description
    Patients receive sorafenib tosylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Sorafenib: Given PO Sorafenib Tosylate: Given PO
    id
    OG002
    title
    Group III (Sorafenib Tosylate)
  4. description
    Patients receive ponatinib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Ponatinib: Given PO Ponatinib Hydrochloride: Given PO
    id
    OG003
    title
    Group IV (Ponatinib Hydrochloride)
  5. description
    Patients receive pacritinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pacritinib: Given PO Pharmacological Study: Correlative studies
    id
    OG004
    title
    Group V (Pacritinib)
  6. description
    Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Ruxolitinib: Given PO
    id
    OG005
    title
    Group VI (Ruxolitinib)
  7. description
    Patients receive idelalisib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Idelalisib: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
    id
    OG006
    title
    Group VII (Idelalisib)
param Type
MEAN
population Description
Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.
reporting Status
POSTED
time Frame
From the date of subject registration to death, regardless of causes of death, assessed up to 3 years
title
Overall Survival
type
SECONDARY
unit Of Measure
Days

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice