ID

36551

Description

Ponatinib in Patients With Resistant Chronic Phase Chronic Myeloid Leukemia (CML) to Characterize the Efficacy and Safety of a Range of Doses; ODM derived from: https://clinicaltrials.gov/show/NCT02467270

Link

https://clinicaltrials.gov/show/NCT02467270

Keywords

Versions (1)
  1. 5/21/19 5/21/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 21, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Myeloid Leukemia, Chronic, Chronic Phase NCT02467270

English

Eligibility Myeloid Leukemia, Chronic, Chronic Phase NCT02467270

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. have cp-cml and are resistant to at least two prior tkis
Description

Leukemia, Myeloid, Chronic-Phase | Resistant to Tyrosine kinase inhibitor Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0023474
UMLS CUI [2,1]
C0332325
UMLS CUI [2,2]
C1268567
UMLS CUI [2,3]
C1265611
2. be male or female patients ≥18 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. have an eastern cooperative oncology group (ecog) performance status of 0, 1, or 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
4. have adequate renal function as defined by the following criterion:
Description

Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
serum creatinine ≤1.5 × upper limit of normal (uln) for institution
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
5. have adequate hepatic function as defined by the following criteria:
Description

Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
total serum bilirubin ≤1.5 × uln, unless due to gilbert's syndrome
Description

Serum total bilirubin measurement | Exception Relationship Gilbert Disease

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0017551
alanine transaminase (alt) ≤2.5 × uln, or ≤5 × uln if leukemic involvement of the liver is present
Description

Alanine aminotransferase measurement | Liver Involvement with Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2,1]
C0023884
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0023418
aspartate transaminase (ast) ≤2.5 × uln, or ≤5 × uln if leukemic involvement of the liver is present
Description

Aspartate aminotransferase measurement | Liver Involvement with Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2,1]
C0023884
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0023418
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. have used any approved tkis or investigational agents within 2 weeks or 6 half-lives of the agent, whichever is longer, prior to receiving study drug
Description

Tyrosine kinase inhibitor | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C1268567
UMLS CUI [2]
C0013230
2. received interferon, cytarabine, or immunotherapy within 14 days, or any other cytotoxic chemotherapy, radiotherapy, or investigational therapy within 28 days prior to receiving the first dose of ponatinib, or have not recovered (> grade 1 by nci common toxicity criteria for adverse effects (ctcae), version 4.0) from aes (except alopecia), due to agents previously administered
Description

Interferon | Cytarabine | Immunotherapy | Cytotoxic Chemotherapy | Therapeutic radiology procedure | Therapy, Investigational | Adverse event caused by Pharmaceutical Preparations | Exception Alopecia | Recovery Lacking CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1]
C3652465
UMLS CUI [2]
C0010711
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0677881
UMLS CUI [5]
C1522449
UMLS CUI [6]
C0949266
UMLS CUI [7,1]
C0877248
UMLS CUI [7,2]
C0015127
UMLS CUI [7,3]
C0013227
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0002170
UMLS CUI [9,1]
C2004454
UMLS CUI [9,2]
C0332268
UMLS CUI [9,3]
C1516728
3. have undergone autologous or allogeneic stem cell transplant <60 days prior to receiving the first dose of ponatinib; have any evidence of ongoing graft-versus-host disease (gvhd) or gvhd requiring immunosuppressive therapy or are being considered for stem cell transplant within 6-12 months of enrollment (note: ponatinib is not to be used as a bridge to stem cell transplant in this trial)
Description

Autologous hematopoietic stem cell transplant | Allogeneic hematopoietic stem cell transplant | Graft-vs-Host Disease | Graft-vs-Host Disease Requirement Therapeutic immunosuppression | Stem cell transplant Anticipated

Data type

boolean

Alias
UMLS CUI [1]
C2193200
UMLS CUI [2]
C4255274
UMLS CUI [3]
C0018133
UMLS CUI [4,1]
C0018133
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0021079
UMLS CUI [5,1]
C1504389
UMLS CUI [5,2]
C3840775
4. are taking medications with a known risk of torsades de pointes
Description

Pharmaceutical Preparations At risk Torsades de Pointes

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0040479
5. have clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:
Description

Cardiovascular Disease Uncontrolled | Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0007222
any history of myocardial infarction (mi), unstable angina, cerebrovascular accident, or transient ischemic attack (tia)
Description

Myocardial Infarction | Angina, Unstable | Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0007787
any history of peripheral vascular infarction, including visceral infarction
Description

Infarction Peripheral vessels | Visceral infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0021308
UMLS CUI [1,2]
C0947487
UMLS CUI [2]
C0151268
any revascularization procedure, including the placement of a stent
Description

Revascularization | Placement of stent

Data type

boolean

Alias
UMLS CUI [1]
C0581603
UMLS CUI [2]
C0522776
congestive heart failure (nyha class iii or iv) within 6 months prior to enrollment, or left ventricular ejection fraction (lvef) less than lower limit of normal, per local institutional standards, within 6 months prior to enrollment
Description

Congestive heart failure New York Heart Association Classification | Left ventricular ejection fraction decreased

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C1096403
history of clinically significant (as determined by the treating physician) atrial arrhythmia or any history of ventricular arrhythmia
Description

Atrial arrhythmia | Ventricular arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0085611
UMLS CUI [2]
C0085612
venous thromboembolism, including deep venous thrombosis or pulmonary embolism, within 6 months prior to enrollment
Description

Venous Thromboembolism | Deep Vein Thrombosis | Pulmonary Embolism

Data type

boolean

Alias
UMLS CUI [1]
C1861172
UMLS CUI [2]
C0149871
UMLS CUI [3]
C0034065
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Similar models

Eligibility Myeloid Leukemia, Chronic, Chronic Phase NCT02467270

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Leukemia, Myeloid, Chronic-Phase | Resistant to Tyrosine kinase inhibitor Quantity
Item
1. have cp-cml and are resistant to at least two prior tkis
boolean
C0023474 (UMLS CUI [1])
C0332325 (UMLS CUI [2,1])
C1268567 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Age
Item
2. be male or female patients ≥18 years old
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. have an eastern cooperative oncology group (ecog) performance status of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Renal function
Item
4. have adequate renal function as defined by the following criterion:
boolean
C0232804 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine ≤1.5 × upper limit of normal (uln) for institution
boolean
C0201976 (UMLS CUI [1])
Liver function
Item
5. have adequate hepatic function as defined by the following criteria:
boolean
C0232741 (UMLS CUI [1])
Serum total bilirubin measurement | Exception Relationship Gilbert Disease
Item
total serum bilirubin ≤1.5 × uln, unless due to gilbert's syndrome
boolean
C1278039 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0017551 (UMLS CUI [2,3])
Alanine aminotransferase measurement | Liver Involvement with Leukemia
Item
alanine transaminase (alt) ≤2.5 × uln, or ≤5 × uln if leukemic involvement of the liver is present
boolean
C0201836 (UMLS CUI [1])
C0023884 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0023418 (UMLS CUI [2,3])
Aspartate aminotransferase measurement | Liver Involvement with Leukemia
Item
aspartate transaminase (ast) ≤2.5 × uln, or ≤5 × uln if leukemic involvement of the liver is present
boolean
C0201899 (UMLS CUI [1])
C0023884 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0023418 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Tyrosine kinase inhibitor | Investigational New Drugs
Item
1. have used any approved tkis or investigational agents within 2 weeks or 6 half-lives of the agent, whichever is longer, prior to receiving study drug
boolean
C1268567 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Interferon | Cytarabine | Immunotherapy | Cytotoxic Chemotherapy | Therapeutic radiology procedure | Therapy, Investigational | Adverse event caused by Pharmaceutical Preparations | Exception Alopecia | Recovery Lacking CTCAE Grades
Item
2. received interferon, cytarabine, or immunotherapy within 14 days, or any other cytotoxic chemotherapy, radiotherapy, or investigational therapy within 28 days prior to receiving the first dose of ponatinib, or have not recovered (> grade 1 by nci common toxicity criteria for adverse effects (ctcae), version 4.0) from aes (except alopecia), due to agents previously administered
boolean
C3652465 (UMLS CUI [1])
C0010711 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0677881 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
C0949266 (UMLS CUI [6])
C0877248 (UMLS CUI [7,1])
C0015127 (UMLS CUI [7,2])
C0013227 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0002170 (UMLS CUI [8,2])
C2004454 (UMLS CUI [9,1])
C0332268 (UMLS CUI [9,2])
C1516728 (UMLS CUI [9,3])
Autologous hematopoietic stem cell transplant | Allogeneic hematopoietic stem cell transplant | Graft-vs-Host Disease | Graft-vs-Host Disease Requirement Therapeutic immunosuppression | Stem cell transplant Anticipated
Item
3. have undergone autologous or allogeneic stem cell transplant <60 days prior to receiving the first dose of ponatinib; have any evidence of ongoing graft-versus-host disease (gvhd) or gvhd requiring immunosuppressive therapy or are being considered for stem cell transplant within 6-12 months of enrollment (note: ponatinib is not to be used as a bridge to stem cell transplant in this trial)
boolean
C2193200 (UMLS CUI [1])
C4255274 (UMLS CUI [2])
C0018133 (UMLS CUI [3])
C0018133 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0021079 (UMLS CUI [4,3])
C1504389 (UMLS CUI [5,1])
C3840775 (UMLS CUI [5,2])
Pharmaceutical Preparations At risk Torsades de Pointes
Item
4. are taking medications with a known risk of torsades de pointes
boolean
C0013227 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0040479 (UMLS CUI [1,3])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease
Item
5. have clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
Myocardial Infarction | Angina, Unstable | Cerebrovascular accident | Transient Ischemic Attack
Item
any history of myocardial infarction (mi), unstable angina, cerebrovascular accident, or transient ischemic attack (tia)
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
Infarction Peripheral vessels | Visceral infarction
Item
any history of peripheral vascular infarction, including visceral infarction
boolean
C0021308 (UMLS CUI [1,1])
C0947487 (UMLS CUI [1,2])
C0151268 (UMLS CUI [2])
Revascularization | Placement of stent
Item
any revascularization procedure, including the placement of a stent
boolean
C0581603 (UMLS CUI [1])
C0522776 (UMLS CUI [2])
Congestive heart failure New York Heart Association Classification | Left ventricular ejection fraction decreased
Item
congestive heart failure (nyha class iii or iv) within 6 months prior to enrollment, or left ventricular ejection fraction (lvef) less than lower limit of normal, per local institutional standards, within 6 months prior to enrollment
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C1096403 (UMLS CUI [2])
Atrial arrhythmia | Ventricular arrhythmia
Item
history of clinically significant (as determined by the treating physician) atrial arrhythmia or any history of ventricular arrhythmia
boolean
C0085611 (UMLS CUI [1])
C0085612 (UMLS CUI [2])
Venous Thromboembolism | Deep Vein Thrombosis | Pulmonary Embolism
Item
venous thromboembolism, including deep venous thrombosis or pulmonary embolism, within 6 months prior to enrollment
boolean
C1861172 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
C0034065 (UMLS CUI [3])
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