ID

41077

Beschrijving

Pegasys in Patients With Chronic Myeloid Leukemia (CML); ODM derived from: https://clinicaltrials.gov/show/NCT01392170

Link

https://clinicaltrials.gov/show/NCT01392170

Trefwoorden

Versies (1)
  1. 19-06-20 19-06-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

19 juni 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Leukemia NCT01392170

Engels

Eligibility Leukemia NCT01392170

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01392170
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients 16 years or older with philadelphia chromosome (ph)-positive or bcr-abl1-positive cml (as determined by cytogenetics, fish, or pcr).
Beschrijving

Age | Philadelphia chromosome positive chronic myelogenous leukemia | Myeloid Leukemia, Chronic | Cytogenetic Analysis | Fluorescent in Situ Hybridization | Polymerase Chain Reaction

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0279543
UMLS CUI [3]
C0023473
UMLS CUI [4]
C0752095
UMLS CUI [5]
C0162789
UMLS CUI [6]
C0032520
2. patients are receiving an fda-approved tki for the management of cml.
Beschrijving

Protein-tyrosine kinase inhibitor | Disease Management CML

Datatype

boolean

Alias
UMLS CUI [1]
C1268567
UMLS CUI [2,1]
C0376636
UMLS CUI [2,2]
C0023473
3. patients must have received tki therapy for at least 24 months and not have increased their tki dose in the last 6 months.
Beschrijving

Protein-tyrosine kinase inhibitor Dose unchanged

Datatype

boolean

Alias
UMLS CUI [1,1]
C1268567
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0442739
4. patients must be in complete cytogenetic remission.
Beschrijving

Cytogenetic Complete Response

Datatype

boolean

Alias
UMLS CUI [1]
C4050364
5. patients must have detectable bcr-abl1 transcript levels meeting at least one of the following criteria: 1. the patient has received therapy for at least 2 years and does not have a sustained major molecular response, or 2. the patient has received therapy for at least 5 years and does not have a sustained complete molecular response.
Beschrijving

BCR-ABL Transcript Levels Detectable | Molecular Major Response Absent | Molecular Complete Response Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1835417
UMLS CUI [1,2]
C1519595
UMLS CUI [1,3]
C0441889
UMLS CUI [1,4]
C3830527
UMLS CUI [2,1]
C4049637
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C4050308
UMLS CUI [3,2]
C0332197
6. patients must not have had a known continuous interruption of tki therapy of greater than 14 consecutive days or for a total of 6 weeks in the 6 months prior to enrollment.
Beschrijving

Temporary interruption of therapy Protein-tyrosine kinase inhibitor Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C3888969
UMLS CUI [1,2]
C1268567
UMLS CUI [1,3]
C0332197
7. patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
8. eastern cooperative oncology group (ecog) performance status </= 2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
9. adequate organ function defined as: bilirubin < 2x upper limit of normal (uln) (unless associated with gilbert's syndrome), creatinine </= 1.5x uln, and serum glutamate pyruvate transaminase (sgpt) or serum glutamate oxaloacetate transaminase (sgot) </= 2.5x uln.
Beschrijving

Organ function | Serum total bilirubin measurement | Exception Associated with Gilbert Disease | Creatinine measurement, serum | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C1278039
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0017551
UMLS CUI [4]
C0201976
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201899
10. men and women of childbearing potential should practice effective methods of contraception. women of childbearing potential must have a negative serum or urine pregnancy test within 1 week of enrollment.
Beschrijving

Females & males of reproductive potential Contraceptive methods | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430061
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430057
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients receiving any non-fda approved tki.
Beschrijving

Protein-tyrosine kinase inhibitor Non-Prescription Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C1268567
UMLS CUI [1,2]
C0013231
2. patients who are pregnant or breast-feeding.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. patients with clinically significant heart disease (nyha class iii or iv).
Beschrijving

Heart Disease New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
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Similar models

Eligibility Leukemia NCT01392170

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01392170
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Philadelphia chromosome positive chronic myelogenous leukemia | Myeloid Leukemia, Chronic | Cytogenetic Analysis | Fluorescent in Situ Hybridization | Polymerase Chain Reaction
Item
1. patients 16 years or older with philadelphia chromosome (ph)-positive or bcr-abl1-positive cml (as determined by cytogenetics, fish, or pcr).
boolean
C0001779 (UMLS CUI [1])
C0279543 (UMLS CUI [2])
C0023473 (UMLS CUI [3])
C0752095 (UMLS CUI [4])
C0162789 (UMLS CUI [5])
C0032520 (UMLS CUI [6])
Protein-tyrosine kinase inhibitor | Disease Management CML
Item
2. patients are receiving an fda-approved tki for the management of cml.
boolean
C1268567 (UMLS CUI [1])
C0376636 (UMLS CUI [2,1])
C0023473 (UMLS CUI [2,2])
Protein-tyrosine kinase inhibitor Dose unchanged
Item
3. patients must have received tki therapy for at least 24 months and not have increased their tki dose in the last 6 months.
boolean
C1268567 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Cytogenetic Complete Response
Item
4. patients must be in complete cytogenetic remission.
boolean
C4050364 (UMLS CUI [1])
BCR-ABL Transcript Levels Detectable | Molecular Major Response Absent | Molecular Complete Response Absent
Item
5. patients must have detectable bcr-abl1 transcript levels meeting at least one of the following criteria: 1. the patient has received therapy for at least 2 years and does not have a sustained major molecular response, or 2. the patient has received therapy for at least 5 years and does not have a sustained complete molecular response.
boolean
C1835417 (UMLS CUI [1,1])
C1519595 (UMLS CUI [1,2])
C0441889 (UMLS CUI [1,3])
C3830527 (UMLS CUI [1,4])
C4049637 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C4050308 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Temporary interruption of therapy Protein-tyrosine kinase inhibitor Absent
Item
6. patients must not have had a known continuous interruption of tki therapy of greater than 14 consecutive days or for a total of 6 weeks in the 6 months prior to enrollment.
boolean
C3888969 (UMLS CUI [1,1])
C1268567 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Informed Consent
Item
7. patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
boolean
C0021430 (UMLS CUI [1])
ECOG performance status
Item
8. eastern cooperative oncology group (ecog) performance status </= 2.
boolean
C1520224 (UMLS CUI [1])
Organ function | Serum total bilirubin measurement | Exception Associated with Gilbert Disease | Creatinine measurement, serum | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
9. adequate organ function defined as: bilirubin < 2x upper limit of normal (uln) (unless associated with gilbert's syndrome), creatinine </= 1.5x uln, and serum glutamate pyruvate transaminase (sgpt) or serum glutamate oxaloacetate transaminase (sgot) </= 2.5x uln.
boolean
C0678852 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0017551 (UMLS CUI [3,3])
C0201976 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
Females & males of reproductive potential Contraceptive methods | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
10. men and women of childbearing potential should practice effective methods of contraception. women of childbearing potential must have a negative serum or urine pregnancy test within 1 week of enrollment.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0430057 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Protein-tyrosine kinase inhibitor Non-Prescription Drugs
Item
1. patients receiving any non-fda approved tki.
boolean
C1268567 (UMLS CUI [1,1])
C0013231 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
2. patients who are pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Heart Disease New York Heart Association Classification
Item
3. patients with clinically significant heart disease (nyha class iii or iv).
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
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