ID

21432

Beskrivning

Study for Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT00129948

Länk

https://clinicaltrials.gov/show/NCT00129948

Nyckelord

Versioner (1)
  1. 2017-04-21 2017-04-21 -
Uppladdad den

21 april 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Leukemia, Myeloid, Acute NCT00129948

Engelsk

Eligibility Leukemia, Myeloid, Acute NCT00129948

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of acute myeloid leukemia (aml) in the second salvage setting: refractory to two prior courses of therapy or primary refractory without response to two previous courses of leukemia therapy.
Beskrivning

Leukemia, Myelocytic, Acute | Salvage second | Therapeutic procedure Quantity Refractory | Therapeutic procedure Quantity leukemia | Unresponsive to Treatment Primary

Datatyp

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2,1]
C0442967
UMLS CUI [2,2]
C0205436
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0205269
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0023418
UMLS CUI [5,1]
C0205269
UMLS CUI [5,2]
C0205225
patients must have received at least two previous courses of induction chemotherapy to be considered in the second salvage setting.
Beskrivning

Induction Chemotherapy Quantity | Salvage second

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3179010
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0442967
UMLS CUI [2,2]
C0205436
patients who are in second relapse, must have had a duration of their second cr or crp of less than six months.
Beskrivning

Relapse second | Complete remission second Duration | Complete Response with Incomplete Platelet Recovery second Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0205436
UMLS CUI [2,1]
C0677874
UMLS CUI [2,2]
C0205436
UMLS CUI [2,3]
C0449238
UMLS CUI [3,1]
C3890735
UMLS CUI [3,2]
C0205436
UMLS CUI [3,3]
C0449238
subjects must have adequate organ and immune function as indicated by the following laboratory values:
Beskrivning

Organ function | Immune function | Laboratory Results

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C1817756
UMLS CUI [3]
C1254595
creatinine clearance ≥ 45 ml/min and ≤ 125 ml/min;
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
total bilirubin ≤ 2.0 mg/dl (≤ 34.2 µmol/l);
Beskrivning

Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
ast (sgot) and alt (sgpt) ≤ 3 x upper limit of normal (uln).
Beskrivning

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
subjects must have an eastern cooperative oncology group (ecog) performance status of < 2, and an estimated life expectancy of at least eight weeks.
Beskrivning

ECOG performance status | Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0023671
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinical evidence of active central nervous system (cns) leukemic involvement
Beskrivning

Central Nervous System Involvement Leukemia Evidence

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0023418
UMLS CUI [1,3]
C0332120
active and uncontrolled infection
Beskrivning

Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
uncontrolled medical problems unrelated to the malignancy that impair patient ability to give informed consent or unacceptably reduce the safety of the proposed treatment
Beskrivning

Patient Problem Uncontrolled | Informed Consent Limited | Therapeutic procedure Safety Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254481
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0439801
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0036043
UMLS CUI [3,3]
C0439801
neurologic or psychiatric disorders that would interfere with informed consent or study follow-up
Beskrivning

nervous system disorder Interferes with Informed Consent | nervous system disorder Interferes with Clinical Study Follow-up | Mental disorders Interfere with Informed Consent | Mental disorders Interfere with Clinical Study Follow-up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C3274571
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C3274571
known or suspected intolerance or hypersensitivity to troxatyl® or closely related compounds such as lamivudine or any of the stated ingredients
Beskrivning

intolerance to Troxatyl | Hypersensitivity Troxatyl | intolerance to Troxatyl Suspected | Hypersensitivity Suspected Troxatyl | intolerance to Troxatyl Compound Related | Hypersensitivity Troxatyl Compound Related | intolerance to Lamivudine | Hypersensitivity Lamivudine | intolerance to Troxatyl Ingredients | Hypersensitivity Troxatyl Ingredients

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0935960
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0935960
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0750491
UMLS CUI [3,3]
C0935960
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0935960
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0935960
UMLS CUI [5,3]
C1706082
UMLS CUI [5,4]
C0439849
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0935960
UMLS CUI [6,3]
C1706082
UMLS CUI [6,4]
C0439849
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C0209738
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0209738
UMLS CUI [9,1]
C1744706
UMLS CUI [9,2]
C0935960
UMLS CUI [9,3]
C0085993
UMLS CUI [10,1]
C0020517
UMLS CUI [10,2]
C0935960
UMLS CUI [10,3]
C0085993
a recent history of alcohol or other substance abuse
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrolment
Beskrivning

Investigational New Drugs | Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
females with a positive pregnancy test at screening
Beskrivning

Pregnancy test positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0240802
subjects who have previously been enrolled into this study and subsequently withdrew
Beskrivning

Study Subject Participation Status | Patient withdrawn from trial

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0422727
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Similar models

Eligibility Leukemia, Myeloid, Acute NCT00129948

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Leukemia, Myelocytic, Acute | Salvage second | Therapeutic procedure Quantity Refractory | Therapeutic procedure Quantity leukemia | Unresponsive to Treatment Primary
Item
confirmed diagnosis of acute myeloid leukemia (aml) in the second salvage setting: refractory to two prior courses of therapy or primary refractory without response to two previous courses of leukemia therapy.
boolean
C0023467 (UMLS CUI [1])
C0442967 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0205269 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0023418 (UMLS CUI [4,3])
C0205269 (UMLS CUI [5,1])
C0205225 (UMLS CUI [5,2])
Induction Chemotherapy Quantity | Salvage second
Item
patients must have received at least two previous courses of induction chemotherapy to be considered in the second salvage setting.
boolean
C3179010 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0442967 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
Relapse second | Complete remission second Duration | Complete Response with Incomplete Platelet Recovery second Duration
Item
patients who are in second relapse, must have had a duration of their second cr or crp of less than six months.
boolean
C0277556 (UMLS CUI [1,1])
C0205436 (UMLS CUI [1,2])
C0677874 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
C3890735 (UMLS CUI [3,1])
C0205436 (UMLS CUI [3,2])
C0449238 (UMLS CUI [3,3])
Organ function | Immune function | Laboratory Results
Item
subjects must have adequate organ and immune function as indicated by the following laboratory values:
boolean
C0678852 (UMLS CUI [1])
C1817756 (UMLS CUI [2])
C1254595 (UMLS CUI [3])
Creatinine measurement, serum
Item
creatinine clearance ≥ 45 ml/min and ≤ 125 ml/min;
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin ≤ 2.0 mg/dl (≤ 34.2 µmol/l);
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast (sgot) and alt (sgpt) ≤ 3 x upper limit of normal (uln).
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
ECOG performance status | Life Expectancy
Item
subjects must have an eastern cooperative oncology group (ecog) performance status of < 2, and an estimated life expectancy of at least eight weeks.
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Central Nervous System Involvement Leukemia Evidence
Item
clinical evidence of active central nervous system (cns) leukemic involvement
boolean
C4050309 (UMLS CUI [1,1])
C0023418 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
Communicable Disease Uncontrolled
Item
active and uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Patient Problem Uncontrolled | Informed Consent Limited | Therapeutic procedure Safety Limited
Item
uncontrolled medical problems unrelated to the malignancy that impair patient ability to give informed consent or unacceptably reduce the safety of the proposed treatment
boolean
C1254481 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0036043 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
nervous system disorder Interferes with Informed Consent | nervous system disorder Interferes with Clinical Study Follow-up | Mental disorders Interfere with Informed Consent | Mental disorders Interfere with Clinical Study Follow-up
Item
neurologic or psychiatric disorders that would interfere with informed consent or study follow-up
boolean
C0027765 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0027765 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C3274571 (UMLS CUI [4,3])
intolerance to Troxatyl | Hypersensitivity Troxatyl | intolerance to Troxatyl Suspected | Hypersensitivity Suspected Troxatyl | intolerance to Troxatyl Compound Related | Hypersensitivity Troxatyl Compound Related | intolerance to Lamivudine | Hypersensitivity Lamivudine | intolerance to Troxatyl Ingredients | Hypersensitivity Troxatyl Ingredients
Item
known or suspected intolerance or hypersensitivity to troxatyl® or closely related compounds such as lamivudine or any of the stated ingredients
boolean
C1744706 (UMLS CUI [1,1])
C0935960 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0935960 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0935960 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0935960 (UMLS CUI [4,3])
C1744706 (UMLS CUI [5,1])
C0935960 (UMLS CUI [5,2])
C1706082 (UMLS CUI [5,3])
C0439849 (UMLS CUI [5,4])
C0020517 (UMLS CUI [6,1])
C0935960 (UMLS CUI [6,2])
C1706082 (UMLS CUI [6,3])
C0439849 (UMLS CUI [6,4])
C1744706 (UMLS CUI [7,1])
C0209738 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0209738 (UMLS CUI [8,2])
C1744706 (UMLS CUI [9,1])
C0935960 (UMLS CUI [9,2])
C0085993 (UMLS CUI [9,3])
C0020517 (UMLS CUI [10,1])
C0935960 (UMLS CUI [10,2])
C0085993 (UMLS CUI [10,3])
Substance Use Disorders
Item
a recent history of alcohol or other substance abuse
boolean
C0038586 (UMLS CUI [1])
Investigational New Drugs | Study Subject Participation Status
Item
subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrolment
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Pregnancy test positive
Item
females with a positive pregnancy test at screening
boolean
C0240802 (UMLS CUI [1])
Study Subject Participation Status | Patient withdrawn from trial
Item
subjects who have previously been enrolled into this study and subsequently withdrew
boolean
C2348568 (UMLS CUI [1])
C0422727 (UMLS CUI [2])
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