Philadelphia chromosome positive chronic myelogenous leukemia | CML BCR negative ABL1 Positive
Item
1. cytogenetic and/or molecular confirmed diagnosis of ph+ and/or bcr-abl1+ cml
boolean
C0279543 (UMLS CUI [1])
C0023473 (UMLS CUI [2,1])
C0457350 (UMLS CUI [2,2])
C1412097 (UMLS CUI [2,3])
C1514241 (UMLS CUI [2,4])
Age
Item
2. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Leukemia, Myeloid, Chronic-Phase
Item
3. chronic phase cml
boolean
C0023474 (UMLS CUI [1])
Prior Therapy | Imatinib Dose Any
Item
4. prior treatment with imatinib, any dose
boolean
C1514463 (UMLS CUI [1])
C0935989 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
Resistance Imatinib
Item
5. resistance to imatinib, as defined by any one of the eln 2013 failure criteria, as follows:
boolean
C0013203 (UMLS CUI [1,1])
C0935989 (UMLS CUI [1,2])
Complete Hematologic Response Absent
Item
no complete hematologic response (chr) at 3 months
boolean
C4050175 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Cytogenetic response Absent | Philadelphia chromosome positive Percentage
Item
no cytogenetic response (cyr) (ph+ > 95%) at 3 months
boolean
C4055168 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0856536 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Less Than Cytogenetic Partial Response | Philadelphia chromosome positive Percentage
Item
less than partial cyr (pcyr, ph+ > 35%) at 6 months
boolean
C0439092 (UMLS CUI [1,1])
C4055169 (UMLS CUI [1,2])
C0856536 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
BCR-ABL1 Percentage
Item
bcr-abl1 > 10% at 6 months
boolean
C1835417 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Cytogenetic Complete Response Absent | Philadelphia chromosome positive Percentage
Item
non complete cyr (ccyr) (ph+ > 0%) at 12 months
boolean
C4050364 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0856536 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
BCR-ABL1 Percentage
Item
bcr-abl1 > 1% at 12 months
boolean
C1835417 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Loss Complete Hematologic Response
Item
loss of chr, at any time
boolean
C1517945 (UMLS CUI [1,1])
C4050175 (UMLS CUI [1,2])
Loss Cytogenetic Complete Response
Item
loss of ccyr, at any time
boolean
C1517945 (UMLS CUI [1,1])
C4050364 (UMLS CUI [1,2])
Loss Molecular Major Response | BCR-ABL1 Percentage
Item
confirmed loss of major molecular response (mmr) (bcr-abl1 bigger or equal to 0.1% in two consecutive tests, of which one bigger or equal to 1%), at any time
boolean
C1517945 (UMLS CUI [1,1])
C4049637 (UMLS CUI [1,2])
C1835417 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
BCR-ABL1 Mutation New
Item
any new bcr-abl1 mutation, at any time
boolean
C1835417 (UMLS CUI [1,1])
C0026882 (UMLS CUI [1,2])
C0205314 (UMLS CUI [1,3])
Childbearing Potential Pregnancy test negative
Item
6. for females of childbearing potential, a negative pregnancy test must be documented prior to enrolment
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods | Partner Contraceptive methods
Item
7. an effective form of contraception with their sexual partners from enrolment through 4 months after the end of treatment
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0682323 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Informed Consent
Item
8. signed written informed consent according to ich/eu/gcp and national local laws prior to any study procedures
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
9. willingness and ability to comply with scheduled visits and study procedures.
boolean
C0525058 (UMLS CUI [1])
Leukemia, Myeloid, Accelerated Phase | Blast Phase
Item
1. accelerated or blastic phase cml
boolean
C0023472 (UMLS CUI [1])
C0005699 (UMLS CUI [2])
nilotinib | dasatinib
Item
2. patients previously treated with nilotinib or dasatinib
boolean
C1721377 (UMLS CUI [1])
C1455147 (UMLS CUI [2])
T315I mutation
Item
3. patients with the t315i mutation
boolean
C3889036 (UMLS CUI [1])
Pancreatitis | Pancreatitis, Chronic | Alcohol abuse
Item
4. history of acute pancreatitis within 1 year of study or history of chronic pancreatitis or of alcohol abuse
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
C0085762 (UMLS CUI [3])
Acute myocardial infarction | Angina, Unstable | Coronary heart disease | Congestive heart failure | Event Cerebrovascular | Cerebrovascular accident | Transient Ischemic Attack | Peripheral arterial occlusive disease
Item
5. patients with history of acute myocardial infarction (ami), unstable angina or coronary heart disease (chd), congestive heart failure, cerebrovascular events (cve) (stroke or transitory ischemic attack), or peripheral artery occlusive disease (paod)
boolean
C0155626 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0010068 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0441471 (UMLS CUI [5,1])
C1880018 (UMLS CUI [5,2])
C0038454 (UMLS CUI [6])
C0007787 (UMLS CUI [7])
C1306889 (UMLS CUI [8])
Pharmaceutical Preparations Associated with Torsades de Pointes | Pharmaceutical Preparations Associated with Prolonged QTc
Item
6. compelled to take medications that are known to be associated with torsades de pointes and/or with significant qtc prolongation
boolean
C0013227 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0040479 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C1969409 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
7. pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Condition compromises Patient safety | Condition Interferes with Drug Evaluation | Illness compromises Patient safety | Illness Interferes with Drug Evaluation
Item
8. any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the drug
boolean
C0348080 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0013175 (UMLS CUI [2,3])
C0221423 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C0221423 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0013175 (UMLS CUI [4,3])
Informed Consent Lacking
Item
9. lack of informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])