ID

41118

Description

A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02130557

Link

https://clinicaltrials.gov/show/NCT02130557

Keywords

  1. 6/26/20 6/26/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 26, 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.

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, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive NCT02130557

Eligibility Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive NCT02130557

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. molecular diagnosis of cp cml of ≤ 6 months (from initial diagnosis).
Description

Chronic-Phase Myeloid Leukemia Disease length Molecular Diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0023474
UMLS CUI [1,2]
C0872146
UMLS CUI [1,3]
C1513388
2. adequate hepatic, renal and pancreatic function.
Description

Liver function | Renal function | Pancreatic function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232786
3. age ≥ 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any prior medical treatment for cml, including tyrosine kinase inhibitors (tkis), with the exception of hydroxyurea and/or anagrelide treatment, which are permitted for up to 6 months prior to study entry (signature of icf) if suitably approved for use in the subject's region.
Description

Prior Therapy CML | Protein-tyrosine kinase inhibitor | Exception hydroxyurea | Exception anagrelide

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0023473
UMLS CUI [2]
C1268567
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0020402
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0051809
2. any past or current central nervous system (cns) involvement, including leptomeningeal leukemia.
Description

Central Nervous System Involvement | Leukemia Leptomeningeal

Data type

boolean

Alias
UMLS CUI [1]
C4050309
UMLS CUI [2,1]
C0023418
UMLS CUI [2,2]
C0521401
3. extramedullary disease only.
Description

Disease Extramedullary

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1517060
4. major surgery or radiotherapy within 14 days of randomization.
Description

Major surgery | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C1522449
5. history of clinically significant or uncontrolled cardiac disease.
Description

Heart Disease Clinical Significance | Heart Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205318
6. known seropositivity to human immunodeficiency virus (hiv), current acute or chronic hepatitis b (hepatitis b surface-antigen positive), hepatitis c, cirrhosis or evidence of decompensated liver disease. patients with resolved hepatitis b can be included.
Description

HIV Seropositivity | Hepatitis B | Hepatitis B, Chronic | Hepatitis B surface antigen positive | Hepatitis C | Liver Cirrhosis | Decompensated liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0524909
UMLS CUI [4]
C0149709
UMLS CUI [5]
C0019196
UMLS CUI [6]
C0023890
UMLS CUI [7]
C4075847
7. recent or ongoing clinically significant gi disorder, e.g. crohn's disease, ulcerative colitis, or prior total or partial gastrectomy.
Description

Gastrointestinal Disease | Crohn Disease | Ulcerative Colitis | Total excision of stomach | Subtotal gastrectomy

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0010346
UMLS CUI [3]
C0009324
UMLS CUI [4]
C0161899
UMLS CUI [5]
C0030600
8. history of another malignancy within 5 years with the exception of basal cell carcinoma or cervical carcinoma in situ or stage 1 or 2 cancer that is considered adequately treated and currently in complete remission for at least l2 months.
Description

Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Malignant Neoplasm TNM clinical staging Treated | Exception Malignant Neoplasm TNM clinical staging In complete remission

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0006826
UMLS CUI [4,3]
C3258246
UMLS CUI [4,4]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0006826
UMLS CUI [5,3]
C3258246
UMLS CUI [5,4]
C0677874
9. current, or recent (within 30 days, or 5 half-lives of investigational product) participation in other clinical trials of investigational agents and/or containing interventional procedures deemed contrary to the objectives and conduct of this trial.
Description

Study Subject Participation Status | Clinical Trial | Investigational New Drugs | Interventional procedure Inconsistent Clinical Trial Current

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3]
C0013230
UMLS CUI [4,1]
C0184661
UMLS CUI [4,2]
C0442809
UMLS CUI [4,3]
C0008976
UMLS CUI [4,4]
C0521116

Similar models

Eligibility Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive NCT02130557

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic-Phase Myeloid Leukemia Disease length Molecular Diagnosis
Item
1. molecular diagnosis of cp cml of ≤ 6 months (from initial diagnosis).
boolean
C0023474 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C1513388 (UMLS CUI [1,3])
Liver function | Renal function | Pancreatic function
Item
2. adequate hepatic, renal and pancreatic function.
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232786 (UMLS CUI [3])
Age
Item
3. age ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy CML | Protein-tyrosine kinase inhibitor | Exception hydroxyurea | Exception anagrelide
Item
1. any prior medical treatment for cml, including tyrosine kinase inhibitors (tkis), with the exception of hydroxyurea and/or anagrelide treatment, which are permitted for up to 6 months prior to study entry (signature of icf) if suitably approved for use in the subject's region.
boolean
C1514463 (UMLS CUI [1,1])
C0023473 (UMLS CUI [1,2])
C1268567 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0020402 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0051809 (UMLS CUI [4,2])
Central Nervous System Involvement | Leukemia Leptomeningeal
Item
2. any past or current central nervous system (cns) involvement, including leptomeningeal leukemia.
boolean
C4050309 (UMLS CUI [1])
C0023418 (UMLS CUI [2,1])
C0521401 (UMLS CUI [2,2])
Disease Extramedullary
Item
3. extramedullary disease only.
boolean
C0012634 (UMLS CUI [1,1])
C1517060 (UMLS CUI [1,2])
Major surgery | Therapeutic radiology procedure
Item
4. major surgery or radiotherapy within 14 days of randomization.
boolean
C0679637 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Heart Disease Clinical Significance | Heart Disease Uncontrolled
Item
5. history of clinically significant or uncontrolled cardiac disease.
boolean
C0018799 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
HIV Seropositivity | Hepatitis B | Hepatitis B, Chronic | Hepatitis B surface antigen positive | Hepatitis C | Liver Cirrhosis | Decompensated liver disease
Item
6. known seropositivity to human immunodeficiency virus (hiv), current acute or chronic hepatitis b (hepatitis b surface-antigen positive), hepatitis c, cirrhosis or evidence of decompensated liver disease. patients with resolved hepatitis b can be included.
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0524909 (UMLS CUI [3])
C0149709 (UMLS CUI [4])
C0019196 (UMLS CUI [5])
C0023890 (UMLS CUI [6])
C4075847 (UMLS CUI [7])
Gastrointestinal Disease | Crohn Disease | Ulcerative Colitis | Total excision of stomach | Subtotal gastrectomy
Item
7. recent or ongoing clinically significant gi disorder, e.g. crohn's disease, ulcerative colitis, or prior total or partial gastrectomy.
boolean
C0017178 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
C0161899 (UMLS CUI [4])
C0030600 (UMLS CUI [5])
Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Malignant Neoplasm TNM clinical staging Treated | Exception Malignant Neoplasm TNM clinical staging In complete remission
Item
8. history of another malignancy within 5 years with the exception of basal cell carcinoma or cervical carcinoma in situ or stage 1 or 2 cancer that is considered adequately treated and currently in complete remission for at least l2 months.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C3258246 (UMLS CUI [4,3])
C1522326 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C3258246 (UMLS CUI [5,3])
C0677874 (UMLS CUI [5,4])
Study Subject Participation Status | Clinical Trial | Investigational New Drugs | Interventional procedure Inconsistent Clinical Trial Current
Item
9. current, or recent (within 30 days, or 5 half-lives of investigational product) participation in other clinical trials of investigational agents and/or containing interventional procedures deemed contrary to the objectives and conduct of this trial.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C0184661 (UMLS CUI [4,1])
C0442809 (UMLS CUI [4,2])
C0008976 (UMLS CUI [4,3])
C0521116 (UMLS CUI [4,4])

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

Fields marked with * are required.

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