ID

41118

Beschreibung

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

Stichworte

Versionen (1)
  1. 26.06.20 26.06.20 -
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See clinicaltrials.gov

Hochgeladen am

26. Juni 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive NCT02130557

Englisch

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

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Chronic-Phase Myeloid Leukemia Disease length Molecular Diagnosis

Datentyp

boolean

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

Liver function | Renal function | Pancreatic function

Datentyp

boolean

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

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschreibung

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Central Nervous System Involvement | Leukemia Leptomeningeal

Datentyp

boolean

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

Disease Extramedullary

Datentyp

boolean

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

Major surgery | Therapeutic radiology procedure

Datentyp

boolean

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

Heart Disease Clinical Significance | Heart Disease Uncontrolled

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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