ID

41077

Description

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

Link

https://clinicaltrials.gov/show/NCT01392170

Keywords

Versions (1)
  1. 6/19/20 6/19/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 19, 2020

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Leukemia NCT01392170

English

Eligibility Leukemia NCT01392170

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01392170
Inclusion Criteria
Description

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).
Description

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

Data type

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.
Description

Protein-tyrosine kinase inhibitor | Disease Management CML

Data type

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.
Description

Protein-tyrosine kinase inhibitor Dose unchanged

Data type

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.
Description

Cytogenetic Complete Response

Data type

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.
Description

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

Data type

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.
Description

Temporary interruption of therapy Protein-tyrosine kinase inhibitor Absent

Data type

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.
Description

Informed Consent

Data type

boolean

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

ECOG performance status

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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
Description

Exclusion Criteria

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

Protein-tyrosine kinase inhibitor Non-Prescription Drugs

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

boolean

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

Heart Disease New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
Back to the top of the page

Similar models

Eligibility Leukemia NCT01392170

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01392170
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial