ID

33554

Description

Front-line Nilotinib Treatment of BCR-ABL+ Chronic Myeloid Leukaemia in Chronic Phase; ODM derived from: https://clinicaltrials.gov/show/NCT01699217

Link

https://clinicaltrials.gov/show/NCT01699217

Keywords

Versions (2)
  1. 12/12/18 12/12/18 -
  2. 12/12/18 12/12/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 12, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Phase Philadelphia Positive NCT01699217

English

Eligibility Chronic Phase Philadelphia Positive NCT01699217

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: >=18 years;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients with chronic phase ph+ and/or bcr-abl+ cml, newly diagnosed (less than 6 months);
Description

CML Chronic-Phase Philadelphia chromosome positive | CML BCR/ABL positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0023474
UMLS CUI [1,2]
C0856536
UMLS CUI [2]
C1292771
prior treatment with hydroxyurea or anagrelide is allowed;
Description

hydroxyurea | anagrelide

Data type

boolean

Alias
UMLS CUI [1]
C0020402
UMLS CUI [2]
C0051809
prior treatment with im for less than 30 days is allowed;
Description

imatinib

Data type

boolean

Alias
UMLS CUI [1]
C0935989
signed written informed const according to ich/eu/gcp and national local laws.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are pregnant (negative pregnancy test is requested within 2 days before nilotinib start) or breast feeding, or adults of reproductive potential not employing an effective method of birth control.
Description

Pregnancy | Pregnancy test negative Requested | Breast Feeding | Females & males of reproductive potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0427780
UMLS CUI [2,2]
C1272683
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C4034483
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
newly diagnosed ph+ and/or bcr-abl+ cml patients in advanced phases (accelerated or blastic phase).
Description

Philadelphia chromosome positive CML Advanced phase | BCR/ABL positive CML Advanced phase | CML Accelerated Phase Philadelphia chromosome positive | Philadelphia chromosome positive CML Blastic Phase | BCR/ABL positive CML Accelerated phase | BCR/ABL positive CML Blastic Phase

Data type

boolean

Alias
UMLS CUI [1,1]
C0279543
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C1292771
UMLS CUI [2,2]
C0205179
UMLS CUI [3,1]
C0023472
UMLS CUI [3,2]
C0856536
UMLS CUI [4,1]
C0279543
UMLS CUI [4,2]
C3899938
UMLS CUI [5,1]
C1292771
UMLS CUI [5,2]
C0457345
UMLS CUI [6,1]
C1292771
UMLS CUI [6,2]
C3899938
prior treatment with nilotinib, dasatinib, or other tyrosine-kinase inhibitors.
Description

nilotinib | dasatinib | Protein-tyrosine kinase inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C1721377
UMLS CUI [2]
C1455147
UMLS CUI [3]
C1268567
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Similar models

Eligibility Chronic Phase Philadelphia Positive NCT01699217

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age: >=18 years;
boolean
C0001779 (UMLS CUI [1])
CML Chronic-Phase Philadelphia chromosome positive | CML BCR/ABL positive
Item
patients with chronic phase ph+ and/or bcr-abl+ cml, newly diagnosed (less than 6 months);
boolean
C0023474 (UMLS CUI [1,1])
C0856536 (UMLS CUI [1,2])
C1292771 (UMLS CUI [2])
hydroxyurea | anagrelide
Item
prior treatment with hydroxyurea or anagrelide is allowed;
boolean
C0020402 (UMLS CUI [1])
C0051809 (UMLS CUI [2])
imatinib
Item
prior treatment with im for less than 30 days is allowed;
boolean
C0935989 (UMLS CUI [1])
Informed Consent
Item
signed written informed const according to ich/eu/gcp and national local laws.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Pregnancy test negative Requested | Breast Feeding | Females & males of reproductive potential Contraceptive methods Absent
Item
patients who are pregnant (negative pregnancy test is requested within 2 days before nilotinib start) or breast feeding, or adults of reproductive potential not employing an effective method of birth control.
boolean
C0032961 (UMLS CUI [1])
C0427780 (UMLS CUI [2,1])
C1272683 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
C4034483 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Philadelphia chromosome positive CML Advanced phase | BCR/ABL positive CML Advanced phase | CML Accelerated Phase Philadelphia chromosome positive | Philadelphia chromosome positive CML Blastic Phase | BCR/ABL positive CML Accelerated phase | BCR/ABL positive CML Blastic Phase
Item
newly diagnosed ph+ and/or bcr-abl+ cml patients in advanced phases (accelerated or blastic phase).
boolean
C0279543 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1292771 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C0023472 (UMLS CUI [3,1])
C0856536 (UMLS CUI [3,2])
C0279543 (UMLS CUI [4,1])
C3899938 (UMLS CUI [4,2])
C1292771 (UMLS CUI [5,1])
C0457345 (UMLS CUI [5,2])
C1292771 (UMLS CUI [6,1])
C3899938 (UMLS CUI [6,2])
nilotinib | dasatinib | Protein-tyrosine kinase inhibitor
Item
prior treatment with nilotinib, dasatinib, or other tyrosine-kinase inhibitors.
boolean
C1721377 (UMLS CUI [1])
C1455147 (UMLS CUI [2])
C1268567 (UMLS CUI [3])
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