ID

17820

Beschrijving

Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00049569

Link

https://clinicaltrials.gov/show/NCT00049569

Trefwoorden

Versies (1)
  1. 04-10-16 04-10-16 -
Geüploaded op

4 oktober 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility L1 Childhood Acute Lymphoblastic Leukemia NCT00049569

Engels

Eligibility L1 Childhood Acute Lymphoblastic Leukemia NCT00049569

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with acute lymphoblastic leukemia (all) in first relapse involving the bone marrow (m3 marrow), with or without associated extramedullary disease; this includes patients who are philadelphia chromosome-positive
Beschrijving

Acute lymphocytic leukemia First Relapse | Bone Marrow Involvement with | Leukemic Blast Count | Disease Extramedullary | Philadelphia chromosome positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023449
UMLS CUI [1,2]
C4054953
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C1314939
UMLS CUI [3]
C2697913
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C1517060
UMLS CUI [5]
C0856536
shortening fraction of >= 28% by echocardiogram, or ejection fraction of >= 50% by gated radionuclide study
Beschrijving

Shortening Fraction | Echocardiogram | Cardiac ejection fraction | Gated Blood-Pool Imaging

Datatype

boolean

Alias
UMLS CUI [1]
C1335957
UMLS CUI [2]
C2243117
UMLS CUI [3]
C0232174
UMLS CUI [4]
C0017200
cumulative prior anthracycline exposure of =< 350 mg/m^2 (each 10 mg/m^2 dose of idarubicin should be calculated as the isotoxic equivalent of 50 mg/m^2 of daunorubicin or adriamycin)
Beschrijving

Anthracycline Previous Cumulative Exposure to | Idarubicin | Daunorubicin | Adriamycin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0282564
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C1511559
UMLS CUI [1,4]
C0332157
UMLS CUI [2]
C0020789
UMLS CUI [3]
C0011015
UMLS CUI [4]
C0085752
all patients and/or their parents or legal guardians must sign a written informed consent
Beschrijving

Informed Consent | Informed Consent parent | Informed Consent Legal Guardians

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030551
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0023226
all institutional, food and drug administration (fda), and national cancer institute (nci) requirements for human studies must be met
Beschrijving

Clinical Research criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with b-cell all (l3 morphology or evidence of myc translocation by molecular or cytogenetic technique) are not eligible
Beschrijving

B-cell childhood acute lymphoblastic leukemia | Leukemic Blast Count | Myc Translocation Evidence of | Molecular Diagnostic Techniques | Cytogenetic Analysis

Datatype

boolean

Alias
UMLS CUI [1]
C0279584
UMLS CUI [2]
C2697913
UMLS CUI [3,1]
C1511357
UMLS CUI [3,2]
C0332120
UMLS CUI [4]
C0949688
UMLS CUI [5]
C0752095
patients with down syndrome are excluded due to the administration of methotrexate in block 2
Beschrijving

Down Syndrome | Methotrexate

Datatype

boolean

Alias
UMLS CUI [1]
C0013080
UMLS CUI [2]
C0025677
patients who have undergone prior stem cell transplantation (sct) are ineligible if:
Beschrijving

Stem cell transplant Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C1504389
UMLS CUI [1,2]
C0205156
they received sct less than 12 months prior to study entry
Beschrijving

Stem cell transplant Time Interval

Datatype

boolean

Alias
UMLS CUI [1,1]
C1504389
UMLS CUI [1,2]
C0872291
they are still receiving immunosuppression for the treatment of graft-versus-host disease (gvhd)
Beschrijving

Therapeutic immunosuppression Graft-vs-Host Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021079
UMLS CUI [1,2]
C0018133
they have active fungal infection at time of study entry
Beschrijving

Mycoses

Datatype

boolean

Alias
UMLS CUI [1]
C0026946
they have had invasive filamentous fungal infection at any time post-sct
Beschrijving

Mycoses Filamentous Invasive Post Stem cell transplant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026946
UMLS CUI [1,2]
C1979891
UMLS CUI [1,3]
C0205281
UMLS CUI [1,4]
C0687676
UMLS CUI [1,5]
C1504389
pregnant or lactating females are ineligible as the medications used in this protocol could be harmful to unborn children and infants
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with prior isolated extramedullary relapse are ineligible
Beschrijving

Relapse Extramedullary Isolated prior

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1517060
UMLS CUI [1,3]
C0205409
UMLS CUI [1,4]
C0332152
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Similar models

Eligibility L1 Childhood Acute Lymphoblastic Leukemia NCT00049569

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Acute lymphocytic leukemia First Relapse | Bone Marrow Involvement with | Leukemic Blast Count | Disease Extramedullary | Philadelphia chromosome positive
Item
patients with acute lymphoblastic leukemia (all) in first relapse involving the bone marrow (m3 marrow), with or without associated extramedullary disease; this includes patients who are philadelphia chromosome-positive
boolean
C0023449 (UMLS CUI [1,1])
C4054953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C2697913 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C1517060 (UMLS CUI [4,2])
C0856536 (UMLS CUI [5])
Shortening Fraction | Echocardiogram | Cardiac ejection fraction | Gated Blood-Pool Imaging
Item
shortening fraction of >= 28% by echocardiogram, or ejection fraction of >= 50% by gated radionuclide study
boolean
C1335957 (UMLS CUI [1])
C2243117 (UMLS CUI [2])
C0232174 (UMLS CUI [3])
C0017200 (UMLS CUI [4])
Anthracycline Previous Cumulative Exposure to | Idarubicin | Daunorubicin | Adriamycin
Item
cumulative prior anthracycline exposure of =< 350 mg/m^2 (each 10 mg/m^2 dose of idarubicin should be calculated as the isotoxic equivalent of 50 mg/m^2 of daunorubicin or adriamycin)
boolean
C0282564 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1511559 (UMLS CUI [1,3])
C0332157 (UMLS CUI [1,4])
C0020789 (UMLS CUI [2])
C0011015 (UMLS CUI [3])
C0085752 (UMLS CUI [4])
Informed Consent | Informed Consent parent | Informed Consent Legal Guardians
Item
all patients and/or their parents or legal guardians must sign a written informed consent
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C0023226 (UMLS CUI [3,2])
Clinical Research criteria Fulfill
Item
all institutional, food and drug administration (fda), and national cancer institute (nci) requirements for human studies must be met
boolean
C0008972 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
B-cell childhood acute lymphoblastic leukemia | Leukemic Blast Count | Myc Translocation Evidence of | Molecular Diagnostic Techniques | Cytogenetic Analysis
Item
patients with b-cell all (l3 morphology or evidence of myc translocation by molecular or cytogenetic technique) are not eligible
boolean
C0279584 (UMLS CUI [1])
C2697913 (UMLS CUI [2])
C1511357 (UMLS CUI [3,1])
C0332120 (UMLS CUI [3,2])
C0949688 (UMLS CUI [4])
C0752095 (UMLS CUI [5])
Down Syndrome | Methotrexate
Item
patients with down syndrome are excluded due to the administration of methotrexate in block 2
boolean
C0013080 (UMLS CUI [1])
C0025677 (UMLS CUI [2])
Stem cell transplant Previous
Item
patients who have undergone prior stem cell transplantation (sct) are ineligible if:
boolean
C1504389 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Stem cell transplant Time Interval
Item
they received sct less than 12 months prior to study entry
boolean
C1504389 (UMLS CUI [1,1])
C0872291 (UMLS CUI [1,2])
Therapeutic immunosuppression Graft-vs-Host Disease
Item
they are still receiving immunosuppression for the treatment of graft-versus-host disease (gvhd)
boolean
C0021079 (UMLS CUI [1,1])
C0018133 (UMLS CUI [1,2])
Mycoses
Item
they have active fungal infection at time of study entry
boolean
C0026946 (UMLS CUI [1])
Mycoses Filamentous Invasive Post Stem cell transplant
Item
they have had invasive filamentous fungal infection at any time post-sct
boolean
C0026946 (UMLS CUI [1,1])
C1979891 (UMLS CUI [1,2])
C0205281 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C1504389 (UMLS CUI [1,5])
Pregnancy | Breast Feeding
Item
pregnant or lactating females are ineligible as the medications used in this protocol could be harmful to unborn children and infants
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Relapse Extramedullary Isolated prior
Item
patients with prior isolated extramedullary relapse are ineligible
boolean
C0035020 (UMLS CUI [1,1])
C1517060 (UMLS CUI [1,2])
C0205409 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
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