ID

41086

Description

Ponatinib - Frontline for Chronic Myeloid Leukemia (CML) in Accelerated Phase (AP); ODM derived from: https://clinicaltrials.gov/show/NCT01570868

Link

https://clinicaltrials.gov/show/NCT01570868

Keywords

Versions (1)
  1. 6/22/20 6/22/20 -
Copyright Holder

See clinicaltrials.gov

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June 22, 2020

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT01570868

English

Eligibility Leukemia NCT01570868

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01570868
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of ph-positive (by cytogenetics or fish) or bcr-abl-positive (by pcr) cml with accelerated phase features at the time of diagnosis.
Description

Philadelphia chromosome positive chronic myelogenous leukemia Cytogenetic Analysis | Philadelphia chromosome positive chronic myelogenous leukemia FISH | BCR/ABL positive Chronic myelogenous leukemia PCR | Accelerated phase features

Data type

boolean

Alias
UMLS CUI [1,1]
C0279543
UMLS CUI [1,2]
C0752095
UMLS CUI [2,1]
C0279543
UMLS CUI [2,2]
C0162789
UMLS CUI [3,1]
C1292771
UMLS CUI [3,2]
C0032520
UMLS CUI [4,1]
C0457345
UMLS CUI [4,2]
C1521970
2. patients must have received no or minimal prior therapy, defined as </=1 month of prior ifn-α (with or without ara-c) and/or an fda-approved tyrosine kinase inhibitor (e.g, dasatinib, nilotinib). prior use of hydroxyurea or anagrelide is allowed with no limitations.
Description

Therapy naive | Therapy Minimal

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0547040
3. age >/=18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. ecog performance of 0-2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
5. adequate end organ function, defined as the following: total bilirubin <1.5x uln, sgpt <2.5x uln,creatinine clearance (crcl) >/= 30 ml/min at screening (calculation according to cockcroft & gault formula).
Description

Organ function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C2711451
6. patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
7. women of pregnancy potential must practice an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized. prior to study enrollment, women of childbearing potential (wocbp) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. in addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control. adequate forms of contraception are barrier methods (e.g., condoms, diaphragm), oral, depo provera, or injectable contraceptives, intrauterine devices, spermicidal jelly or foam, abstinence, and tubal ligation. women and men must continue birth control for the duration of the trial & at least 3 months after the last dose of study drug.
Description

Childbearing Potential Contraceptive methods | Postmenopausal state | Amenorrhea Duration | Gender Contraceptive methods | Contraception, Barrier | Condoms | Vaginal contraceptive diaphragm | Contraceptives, Oral | Depo-Provera | Injectable contraception | Intrauterine Devices | Spermicidal foam or jelly | Sexual Abstinence | Tubal Ligation

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C0002453
UMLS CUI [3,2]
C0449238
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
UMLS CUI [5]
C0004764
UMLS CUI [6]
C0677582
UMLS CUI [7]
C0042241
UMLS CUI [8]
C0009905
UMLS CUI [9]
C0699700
UMLS CUI [10]
C1262153
UMLS CUI [11]
C0021900
UMLS CUI [12]
C3843423
UMLS CUI [13]
C0036899
UMLS CUI [14]
C0520483
8. **continued from above: all wocbp must have a negative serum or urine pregnancy test within 7 days prior to first receiving investigational product. if the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study.
Description

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. nyha cardiac class 3-4 heart disease
Description

Heart Disease New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
2. cardiac symptoms: patients meeting the following criteria are not eligible: history of unstable angina, myocardial infarction, tia, stroke, peripheral arterial occlusive disease, venous thromboembolism or pulmonary embolism; any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes); prolonged qtc interval on pre-entry electrocardiogram (> 470 msec) on both the fridericia and bazett's correction; symptomatic congestive heart failure within 3 months prior to first dose of ponatinib (nyha class iii or iv).
Description

Cardiac symptom | Angina, Unstable | Myocardial Infarction | Transient Ischemic Attack | Cerebrovascular accident | Peripheral arterial occlusive disease | Venous Thromboembolism | Pulmonary Embolism | Ventricular arrhythmia | Tachycardia, Ventricular | Ventricular Fibrillation | Torsades de Pointes | Electrocardiogram QT corrected interval prolonged | QTcF - Fridericia's Correction Formula | Bazett formula | Symptomatic congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C0741933
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0007787
UMLS CUI [5]
C0038454
UMLS CUI [6]
C1306889
UMLS CUI [7]
C1861172
UMLS CUI [8]
C0034065
UMLS CUI [9]
C0085612
UMLS CUI [10]
C0042514
UMLS CUI [11]
C0042510
UMLS CUI [12]
C0040479
UMLS CUI [13]
C0855333
UMLS CUI [14]
C1882513
UMLS CUI [15]
C4038411
UMLS CUI [16,1]
C0742758
UMLS CUI [16,2]
C1275491
3. patients with active, uncontrolled psychiatric disorders including: psychosis, major depression, and bipolar disorders.
Description

Mental disorders Uncontrolled | Psychotic Disorders | Major Depressive Disorder | Bipolar Disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0033975
UMLS CUI [3]
C1269683
UMLS CUI [4]
C0005586
4. pregnant or breast-feeding women are excluded.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
5. patients with uncontrolled hypertension (defined as sustained stage 2 hypertension, i.e., systolic bp >/=160 mmhg or diastolic bp >/=100 mmhg).
Description

Uncontrolled hypertension | Hypertensive disease Stage | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C1306673
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
6. patients with history of pancreatitis.
Description

History of pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C3887021
7. patients in late chronic phase (i.e., time from diagnosis to treatment >6 months), or blast phase are excluded. the definitions of cml phases are as follows: a. early chronic phase: time from diagnosis to therapy </= 6 months; b. late chronic phase: time from diagnosis to therapy > 6 months; c. blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow; d. accelerated phase cml: presence of any of the following features: peripheral or marrow blasts 15% or more; peripheral or marrow basophils 20% or more; thrombocytopenia < 100 x 10(9)/l unrelated to therapy; documented extramedullary blastic disease outside liver or spleen.
Description

Chronic phase Late | Blast Phase

Data type

boolean

Alias
UMLS CUI [1,1]
C0457343
UMLS CUI [1,2]
C0205087
UMLS CUI [2]
C0005699
8. **continued from above: e. clonal evolution defined as the presence of additional chromosomal abnormalities other than the ph chromosome has been historically been included as a criterion for accelerated phase. however, patients with clonal evolution as the only criterion of accelerated phase have a significantly better prognosis, and when present at diagnosis may not impact the prognosis at all. thus, patients with clonal evolution and no other criteria for accelerated phase will be eligible for this study.
Description

Clonal Evolution Eligible | Criteria Other Absent Accelerated phase

Data type

boolean

Alias
UMLS CUI [1,1]
C1516669
UMLS CUI [1,2]
C1548635
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0332197
UMLS CUI [2,4]
C0457345
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Similar models

Eligibility Leukemia NCT01570868

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01570868
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Philadelphia chromosome positive chronic myelogenous leukemia Cytogenetic Analysis | Philadelphia chromosome positive chronic myelogenous leukemia FISH | BCR/ABL positive Chronic myelogenous leukemia PCR | Accelerated phase features
Item
1. diagnosis of ph-positive (by cytogenetics or fish) or bcr-abl-positive (by pcr) cml with accelerated phase features at the time of diagnosis.
boolean
C0279543 (UMLS CUI [1,1])
C0752095 (UMLS CUI [1,2])
C0279543 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
C1292771 (UMLS CUI [3,1])
C0032520 (UMLS CUI [3,2])
C0457345 (UMLS CUI [4,1])
C1521970 (UMLS CUI [4,2])
Therapy naive | Therapy Minimal
Item
2. patients must have received no or minimal prior therapy, defined as </=1 month of prior ifn-α (with or without ara-c) and/or an fda-approved tyrosine kinase inhibitor (e.g, dasatinib, nilotinib). prior use of hydroxyurea or anagrelide is allowed with no limitations.
boolean
C0919936 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0547040 (UMLS CUI [2,2])
Age
Item
3. age >/=18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance of 0-2.
boolean
C1520224 (UMLS CUI [1])
Organ function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
5. adequate end organ function, defined as the following: total bilirubin <1.5x uln, sgpt <2.5x uln,creatinine clearance (crcl) >/= 30 ml/min at screening (calculation according to cockcroft & gault formula).
boolean
C0678852 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C2711451 (UMLS CUI [4])
Informed Consent
Item
6. patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Postmenopausal state | Amenorrhea Duration | Gender Contraceptive methods | Contraception, Barrier | Condoms | Vaginal contraceptive diaphragm | Contraceptives, Oral | Depo-Provera | Injectable contraception | Intrauterine Devices | Spermicidal foam or jelly | Sexual Abstinence | Tubal Ligation
Item
7. women of pregnancy potential must practice an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized. prior to study enrollment, women of childbearing potential (wocbp) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. in addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control. adequate forms of contraception are barrier methods (e.g., condoms, diaphragm), oral, depo provera, or injectable contraceptives, intrauterine devices, spermicidal jelly or foam, abstinence, and tubal ligation. women and men must continue birth control for the duration of the trial & at least 3 months after the last dose of study drug.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C0002453 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0004764 (UMLS CUI [5])
C0677582 (UMLS CUI [6])
C0042241 (UMLS CUI [7])
C0009905 (UMLS CUI [8])
C0699700 (UMLS CUI [9])
C1262153 (UMLS CUI [10])
C0021900 (UMLS CUI [11])
C3843423 (UMLS CUI [12])
C0036899 (UMLS CUI [13])
C0520483 (UMLS CUI [14])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
8. **continued from above: all wocbp must have a negative serum or urine pregnancy test within 7 days prior to first receiving investigational product. if the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Heart Disease New York Heart Association Classification
Item
1. nyha cardiac class 3-4 heart disease
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Cardiac symptom | Angina, Unstable | Myocardial Infarction | Transient Ischemic Attack | Cerebrovascular accident | Peripheral arterial occlusive disease | Venous Thromboembolism | Pulmonary Embolism | Ventricular arrhythmia | Tachycardia, Ventricular | Ventricular Fibrillation | Torsades de Pointes | Electrocardiogram QT corrected interval prolonged | QTcF - Fridericia's Correction Formula | Bazett formula | Symptomatic congestive heart failure New York Heart Association Classification
Item
2. cardiac symptoms: patients meeting the following criteria are not eligible: history of unstable angina, myocardial infarction, tia, stroke, peripheral arterial occlusive disease, venous thromboembolism or pulmonary embolism; any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes); prolonged qtc interval on pre-entry electrocardiogram (> 470 msec) on both the fridericia and bazett's correction; symptomatic congestive heart failure within 3 months prior to first dose of ponatinib (nyha class iii or iv).
boolean
C0741933 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C1306889 (UMLS CUI [6])
C1861172 (UMLS CUI [7])
C0034065 (UMLS CUI [8])
C0085612 (UMLS CUI [9])
C0042514 (UMLS CUI [10])
C0042510 (UMLS CUI [11])
C0040479 (UMLS CUI [12])
C0855333 (UMLS CUI [13])
C1882513 (UMLS CUI [14])
C4038411 (UMLS CUI [15])
C0742758 (UMLS CUI [16,1])
C1275491 (UMLS CUI [16,2])
Mental disorders Uncontrolled | Psychotic Disorders | Major Depressive Disorder | Bipolar Disorder
Item
3. patients with active, uncontrolled psychiatric disorders including: psychosis, major depression, and bipolar disorders.
boolean
C0004936 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0033975 (UMLS CUI [2])
C1269683 (UMLS CUI [3])
C0005586 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
4. pregnant or breast-feeding women are excluded.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Uncontrolled hypertension | Hypertensive disease Stage | Systolic Pressure | Diastolic blood pressure
Item
5. patients with uncontrolled hypertension (defined as sustained stage 2 hypertension, i.e., systolic bp >/=160 mmhg or diastolic bp >/=100 mmhg).
boolean
C1868885 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C1306673 (UMLS CUI [2,2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
History of pancreatitis
Item
6. patients with history of pancreatitis.
boolean
C3887021 (UMLS CUI [1])
Chronic phase Late | Blast Phase
Item
7. patients in late chronic phase (i.e., time from diagnosis to treatment >6 months), or blast phase are excluded. the definitions of cml phases are as follows: a. early chronic phase: time from diagnosis to therapy </= 6 months; b. late chronic phase: time from diagnosis to therapy > 6 months; c. blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow; d. accelerated phase cml: presence of any of the following features: peripheral or marrow blasts 15% or more; peripheral or marrow basophils 20% or more; thrombocytopenia < 100 x 10(9)/l unrelated to therapy; documented extramedullary blastic disease outside liver or spleen.
boolean
C0457343 (UMLS CUI [1,1])
C0205087 (UMLS CUI [1,2])
C0005699 (UMLS CUI [2])
Clonal Evolution Eligible | Criteria Other Absent Accelerated phase
Item
8. **continued from above: e. clonal evolution defined as the presence of additional chromosomal abnormalities other than the ph chromosome has been historically been included as a criterion for accelerated phase. however, patients with clonal evolution as the only criterion of accelerated phase have a significantly better prognosis, and when present at diagnosis may not impact the prognosis at all. thus, patients with clonal evolution and no other criteria for accelerated phase will be eligible for this study.
boolean
C1516669 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0457345 (UMLS CUI [2,4])
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