ID

41131

Beskrivning

Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01174043

Länk

https://clinicaltrials.gov/show/NCT01174043

Nyckelord

Versioner (1)
  1. 2020-06-28 2020-06-28 -
Rättsinnehavare

See clinicaltrials.gov

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28 juni 2020

DOI

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Creative Commons BY 4.0
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Eligibility Leukemia, Myelomonocytic, Acute NCT01174043

Engelsk

Eligibility Leukemia, Myelomonocytic, Acute NCT01174043

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of aml with no history of previous clonal/malignant hematologic disorders such as myelodysplastic syndromes or myeloproliferative disorders.
Beskrivning

Leukemia, Myelocytic, Acute | Hematologic Neoplasms Absent | MYELODYSPLASTIC SYNDROME Absent | Myeloproliferative disease Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2,1]
C0376545
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3463824
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0027022
UMLS CUI [4,2]
C0332197
newly diagnosed patients will be age 70 or older
Beskrivning

Patients Newly Diagnosed | Age

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1518321
UMLS CUI [2]
C0001779
relapses patients will be age 60 or older any time following first relapse, if patient is not considered candidate/not interested in salvage chemotherapy.
Beskrivning

Recurrent disease | Age | Status post First Relapse | Patient Inappropriate Salvage Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C4054953
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C1548788
UMLS CUI [4,3]
C0085405
UMLS CUI [4,4]
C0392920
refractory disease patients will be age 18-59 who have failed at least 2 lines of conventional chemotherapy (1 induction and 1 salvage)
Beskrivning

Refractory Disease | Age | Chemotherapy Failed | Induction Chemotherapy Failed | Salvage Chemotherapy Failed

Datatyp

boolean

Alias
UMLS CUI [1]
C1514815
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0231175
UMLS CUI [4,1]
C3179010
UMLS CUI [4,2]
C0231175
UMLS CUI [5,1]
C0085405
UMLS CUI [5,2]
C0392920
UMLS CUI [5,3]
C0231175
patient must have discontinued all previous therapies for aml at least 14 days and recovered from the non-hematologic side effects of the therapy.
Beskrivning

Prior Therapy Discontinued AML | Adverse effects Due to Therapy | Patient recovered

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0023467
UMLS CUI [2,1]
C0879626
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0087111
UMLS CUI [3]
C1115804
laboratory tests must be within protocol-specified ranges
Beskrivning

Laboratory tests Consistent with Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C2348563
patient must be able to swallow and tolerate oral medication.
Beskrivning

Able to swallow Oral Medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with known central nervous system (cns) leukemia by spinal fluid cytology, flow cytometry or imaging.
Beskrivning

Central nervous system leukemia | Cerebrospinal Fluid Cytology | Flow Cytometry | Imaging

Datatyp

boolean

Alias
UMLS CUI [1]
C1332884
UMLS CUI [2,1]
C0007806
UMLS CUI [2,2]
C1305671
UMLS CUI [3]
C0016263
UMLS CUI [4]
C0011923
history of antecedent pre-leukemic hematologic disorders such as myelodysplastic syndromes or myeloproliferative disorders.
Beskrivning

Hematological Disease | MYELODYSPLASTIC SYNDROME | Myeloproliferative disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2]
C3463824
UMLS CUI [3]
C0027022
diagnosis of acute promyelocytic leukemia (apl)
Beskrivning

Acute Promyelocytic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0023487
patients who require chronic anticoagulation, are current smokers or who are taking rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital and st. john's wort are not eligible.
Beskrivning

Anticoagulation Therapy chronic required | Tobacco use | rifabutin | rifapentine | phenytoin | carbamazepine | phenobarbital | St. John's wort extract

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C1514873
UMLS CUI [2]
C0543414
UMLS CUI [3]
C0140575
UMLS CUI [4]
C0073372
UMLS CUI [5]
C0031507
UMLS CUI [6]
C0006949
UMLS CUI [7]
C0031412
UMLS CUI [8]
C0813171
patients with active corneal erosions or history of abnormal corneal sensitivity test.
Beskrivning

Corneal erosion | Corneal Sensitivity Abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0392163
UMLS CUI [2,1]
C1707516
UMLS CUI [2,2]
C0205161
patients with serious illness such as: significant ongoing or active infection, new york heart association (nyha) grade ii or greater congestive heart failure, unstable angina (anginal symptoms at rest), new onset angina (began within the last 3 months), myocardial infarction within the past 6 months, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy, cerebrovascular accident within past 3 months, or psychiatric illness that would limit compliance with the study requirements.
Beskrivning

Illness Serious | Communicable Disease | Congestive heart failure New York Heart Association Classification | Angina, Unstable | New onset Angina Pectoris | Myocardial Infarction | Ventricular arrhythmia Requirement Anti-Arrhythmia Agents | Cerebrovascular accident | Mental disorder Limiting Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0009450
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C1275491
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0746890
UMLS CUI [5,2]
C0002962
UMLS CUI [6]
C0027051
UMLS CUI [7,1]
C0085612
UMLS CUI [7,2]
C1514873
UMLS CUI [7,3]
C0003195
UMLS CUI [8]
C0038454
UMLS CUI [9,1]
C0004936
UMLS CUI [9,2]
C0439801
UMLS CUI [9,3]
C0525058
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Similar models

Eligibility Leukemia, Myelomonocytic, Acute NCT01174043

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Leukemia, Myelocytic, Acute | Hematologic Neoplasms Absent | MYELODYSPLASTIC SYNDROME Absent | Myeloproliferative disease Absent
Item
diagnosis of aml with no history of previous clonal/malignant hematologic disorders such as myelodysplastic syndromes or myeloproliferative disorders.
boolean
C0023467 (UMLS CUI [1])
C0376545 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3463824 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0027022 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Patients Newly Diagnosed | Age
Item
newly diagnosed patients will be age 70 or older
boolean
C0030705 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
Recurrent disease | Age | Status post First Relapse | Patient Inappropriate Salvage Chemotherapy
Item
relapses patients will be age 60 or older any time following first relapse, if patient is not considered candidate/not interested in salvage chemotherapy.
boolean
C0277556 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C4054953 (UMLS CUI [3,2])
C0030705 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C0085405 (UMLS CUI [4,3])
C0392920 (UMLS CUI [4,4])
Refractory Disease | Age | Chemotherapy Failed | Induction Chemotherapy Failed | Salvage Chemotherapy Failed
Item
refractory disease patients will be age 18-59 who have failed at least 2 lines of conventional chemotherapy (1 induction and 1 salvage)
boolean
C1514815 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C3179010 (UMLS CUI [4,1])
C0231175 (UMLS CUI [4,2])
C0085405 (UMLS CUI [5,1])
C0392920 (UMLS CUI [5,2])
C0231175 (UMLS CUI [5,3])
Prior Therapy Discontinued AML | Adverse effects Due to Therapy | Patient recovered
Item
patient must have discontinued all previous therapies for aml at least 14 days and recovered from the non-hematologic side effects of the therapy.
boolean
C1514463 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0023467 (UMLS CUI [1,3])
C0879626 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1115804 (UMLS CUI [3])
Laboratory tests Consistent with Study Protocol
Item
laboratory tests must be within protocol-specified ranges
boolean
C0022885 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Able to swallow Oral Medication
Item
patient must be able to swallow and tolerate oral medication.
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Central nervous system leukemia | Cerebrospinal Fluid Cytology | Flow Cytometry | Imaging
Item
patients with known central nervous system (cns) leukemia by spinal fluid cytology, flow cytometry or imaging.
boolean
C1332884 (UMLS CUI [1])
C0007806 (UMLS CUI [2,1])
C1305671 (UMLS CUI [2,2])
C0016263 (UMLS CUI [3])
C0011923 (UMLS CUI [4])
Hematological Disease | MYELODYSPLASTIC SYNDROME | Myeloproliferative disease
Item
history of antecedent pre-leukemic hematologic disorders such as myelodysplastic syndromes or myeloproliferative disorders.
boolean
C0018939 (UMLS CUI [1])
C3463824 (UMLS CUI [2])
C0027022 (UMLS CUI [3])
Acute Promyelocytic Leukemia
Item
diagnosis of acute promyelocytic leukemia (apl)
boolean
C0023487 (UMLS CUI [1])
Anticoagulation Therapy chronic required | Tobacco use | rifabutin | rifapentine | phenytoin | carbamazepine | phenobarbital | St. John's wort extract
Item
patients who require chronic anticoagulation, are current smokers or who are taking rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital and st. john's wort are not eligible.
boolean
C0003281 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0543414 (UMLS CUI [2])
C0140575 (UMLS CUI [3])
C0073372 (UMLS CUI [4])
C0031507 (UMLS CUI [5])
C0006949 (UMLS CUI [6])
C0031412 (UMLS CUI [7])
C0813171 (UMLS CUI [8])
Corneal erosion | Corneal Sensitivity Abnormal
Item
patients with active corneal erosions or history of abnormal corneal sensitivity test.
boolean
C0392163 (UMLS CUI [1])
C1707516 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
Illness Serious | Communicable Disease | Congestive heart failure New York Heart Association Classification | Angina, Unstable | New onset Angina Pectoris | Myocardial Infarction | Ventricular arrhythmia Requirement Anti-Arrhythmia Agents | Cerebrovascular accident | Mental disorder Limiting Protocol Compliance
Item
patients with serious illness such as: significant ongoing or active infection, new york heart association (nyha) grade ii or greater congestive heart failure, unstable angina (anginal symptoms at rest), new onset angina (began within the last 3 months), myocardial infarction within the past 6 months, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy, cerebrovascular accident within past 3 months, or psychiatric illness that would limit compliance with the study requirements.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0746890 (UMLS CUI [5,1])
C0002962 (UMLS CUI [5,2])
C0027051 (UMLS CUI [6])
C0085612 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C0003195 (UMLS CUI [7,3])
C0038454 (UMLS CUI [8])
C0004936 (UMLS CUI [9,1])
C0439801 (UMLS CUI [9,2])
C0525058 (UMLS CUI [9,3])
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