ID

35350

Description

Activity and Risk Profile of Ponatinib in Chronic Phase Patients With Chronic Myeloid Leukemia Resistant to Imatinib; ODM derived from: https://clinicaltrials.gov/show/NCT02398825

Link

https://clinicaltrials.gov/show/NCT02398825

Keywords

Versions (1)
  1. 3/1/19 3/1/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 1, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Myeloid Leukemia NCT02398825

English

Eligibility Chronic Myeloid Leukemia NCT02398825

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. cytogenetic and/or molecular confirmed diagnosis of ph+ and/or bcr-abl1+ cml
Description

Philadelphia chromosome positive chronic myelogenous leukemia | CML BCR negative ABL1 Positive

Data type

boolean

Alias
UMLS CUI [1]
C0279543
UMLS CUI [2,1]
C0023473
UMLS CUI [2,2]
C0457350
UMLS CUI [2,3]
C1412097
UMLS CUI [2,4]
C1514241
2. age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. chronic phase cml
Description

Leukemia, Myeloid, Chronic-Phase

Data type

boolean

Alias
UMLS CUI [1]
C0023474
4. prior treatment with imatinib, any dose
Description

Prior Therapy | Imatinib Dose Any

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C0935989
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1552551
5. resistance to imatinib, as defined by any one of the eln 2013 failure criteria, as follows:
Description

Resistance Imatinib

Data type

boolean

Alias
UMLS CUI [1,1]
C0013203
UMLS CUI [1,2]
C0935989
no complete hematologic response (chr) at 3 months
Description

Complete Hematologic Response Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C4050175
UMLS CUI [1,2]
C0332197
no cytogenetic response (cyr) (ph+ > 95%) at 3 months
Description

Cytogenetic response Absent | Philadelphia chromosome positive Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C4055168
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0856536
UMLS CUI [2,2]
C0439165
less than partial cyr (pcyr, ph+ > 35%) at 6 months
Description

Less Than Cytogenetic Partial Response | Philadelphia chromosome positive Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0439092
UMLS CUI [1,2]
C4055169
UMLS CUI [2,1]
C0856536
UMLS CUI [2,2]
C0439165
bcr-abl1 > 10% at 6 months
Description

BCR-ABL1 Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C1835417
UMLS CUI [1,2]
C0439165
non complete cyr (ccyr) (ph+ > 0%) at 12 months
Description

Cytogenetic Complete Response Absent | Philadelphia chromosome positive Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C4050364
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0856536
UMLS CUI [2,2]
C0439165
bcr-abl1 > 1% at 12 months
Description

BCR-ABL1 Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C1835417
UMLS CUI [1,2]
C0439165
loss of chr, at any time
Description

Loss Complete Hematologic Response

Data type

boolean

Alias
UMLS CUI [1,1]
C1517945
UMLS CUI [1,2]
C4050175
loss of ccyr, at any time
Description

Loss Cytogenetic Complete Response

Data type

boolean

Alias
UMLS CUI [1,1]
C1517945
UMLS CUI [1,2]
C4050364
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
Description

Loss Molecular Major Response | BCR-ABL1 Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C1517945
UMLS CUI [1,2]
C4049637
UMLS CUI [2,1]
C1835417
UMLS CUI [2,2]
C0439165
any new bcr-abl1 mutation, at any time
Description

BCR-ABL1 Mutation New

Data type

boolean

Alias
UMLS CUI [1,1]
C1835417
UMLS CUI [1,2]
C0026882
UMLS CUI [1,3]
C0205314
6. for females of childbearing potential, a negative pregnancy test must be documented prior to enrolment
Description

Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
7. an effective form of contraception with their sexual partners from enrolment through 4 months after the end of treatment
Description

Childbearing Potential Contraceptive methods | Partner Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C0700589
8. signed written informed consent according to ich/eu/gcp and national local laws prior to any study procedures
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
9. willingness and ability to comply with scheduled visits and study procedures.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. accelerated or blastic phase cml
Description

Leukemia, Myeloid, Accelerated Phase | Blast Phase

Data type

boolean

Alias
UMLS CUI [1]
C0023472
UMLS CUI [2]
C0005699
2. patients previously treated with nilotinib or dasatinib
Description

nilotinib | dasatinib

Data type

boolean

Alias
UMLS CUI [1]
C1721377
UMLS CUI [2]
C1455147
3. patients with the t315i mutation
Description

T315I mutation

Data type

boolean

Alias
UMLS CUI [1]
C3889036
4. history of acute pancreatitis within 1 year of study or history of chronic pancreatitis or of alcohol abuse
Description

Pancreatitis | Pancreatitis, Chronic | Alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0149521
UMLS CUI [3]
C0085762
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)
Description

Acute myocardial infarction | Angina, Unstable | Coronary heart disease | Congestive heart failure | Event Cerebrovascular | Cerebrovascular accident | Transient Ischemic Attack | Peripheral arterial occlusive disease

Data type

boolean

Alias
UMLS CUI [1]
C0155626
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0010068
UMLS CUI [4]
C0018802
UMLS CUI [5,1]
C0441471
UMLS CUI [5,2]
C1880018
UMLS CUI [6]
C0038454
UMLS CUI [7]
C0007787
UMLS CUI [8]
C1306889
6. compelled to take medications that are known to be associated with torsades de pointes and/or with significant qtc prolongation
Description

Pharmaceutical Preparations Associated with Torsades de Pointes | Pharmaceutical Preparations Associated with Prolonged QTc

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0040479
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C1969409
7. pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the drug
Description

Condition compromises Patient safety | Condition Interferes with Drug Evaluation | Illness compromises Patient safety | Illness Interferes with Drug Evaluation

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0013175
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C1113679
UMLS CUI [4,1]
C0221423
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0013175
9. lack of informed consent
Description

Informed Consent Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332268
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Similar models

Eligibility Chronic Myeloid Leukemia NCT02398825

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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