ID

18487

Beskrivning

Study of Dasatinib in Patients With Chronic Myelogenous Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00254423

Länk

https://clinicaltrials.gov/show/NCT00254423

Nyckelord

Versioner (1)
  1. 2016-11-07 2016-11-07 -
Uppladdad den

7 november 2016

DOI

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Creative Commons BY 4.0
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Eligibility Chronic Myelogenous Leukemia NCT00254423

Engelsk

Eligibility Chronic Myelogenous Leukemia NCT00254423

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of ph-positive or bcr-abl positive cml in early chronic phase cml (i.e., time from diagnosis </= 12 months). except for hydroxyurea, patients must have received no or minimal prior therapy, defined as <1 month (30 days) of prior ifn-alpha (with or without ara-c) and/or an fda approved tki
Beskrivning

Philadelphia Chromosome; BCR-ABL Fusion Gene; Myeloid Leukemia, Chronic | hydroxyurea | Interferon-alpha

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031526
UMLS CUI [1,2]
C1835417
UMLS CUI [1,3]
C0023473
UMLS CUI [2]
C0020402
UMLS CUI [3]
C0002199
2. continued from above #1: 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
Beskrivning

2. Eligibility Determination | Clonal Evolution; Accelerated phase chronic myologenic leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0013893
UMLS CUI [2,1]
C1516669
UMLS CUI [2,2]
C0919870
3. age >/= 16 years (age >18 years to participate in optional symptom burden assessment)
Beskrivning

3. Age | Symptom burden score

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C3533162
4. ecog performance of 0-2
Beskrivning

4. Eastern Cooperative Oncology Group

Datatyp

boolean

Alias
UMLS CUI [1]
C1512162
5. adequate end organ function, defined as the following: total bilirubin <1.5 x uln, sgpt <2.5x uln, creatinine <1.5x uln
Beskrivning

5. Bilirubin, total measurement | Alanine Transaminase | Creatinine

Datatyp

boolean

Alias
UMLS CUI [1]
C0201913
UMLS CUI [2]
C0001899
UMLS CUI [3]
C0010294
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.
Beskrivning

6. Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
7. reliable telephone access to receive calls from an interactive voice response system (ivr) (only applicable to patients who will participate in optional symptom burden assessment)
Beskrivning

7. Provision of telephone | Clinical Trial Interactive Response Technology Documentation; Symptom burden score

Datatyp

boolean

Alias
UMLS CUI [1]
C0729989
UMLS CUI [2,1]
C3890944
UMLS CUI [2,2]
C3533162
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. new york heart association (nyha) cardiac class 3-4 heart disease
Beskrivning

8. New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C1275491
2. cardiac symptoms: patients meeting the following criteria are not eligible unless cleared by cardiology: uncontrolled angina within 3 months; diagnosed or suspected congenital long qt syndrome; any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes); prolonged qtc interval on pre-entry electrocardiogram (> 450 msec) on both the fridericia and bazett's correction; uncontrolled hypertension; history of significant bleeding disorder unrelated to cancer, including:
Beskrivning

Angina Pectoris; Unresponsive to Treatment | Congenital long QT syndrome | Ventricular arrhythmia | Prolonged QTc interval | Uncontrolled hypertension | Blood Coagulation Disorders

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C0205269
UMLS CUI [2]
C1141890
UMLS CUI [3]
C0085612
UMLS CUI [4]
C1560305
UMLS CUI [5]
C1868885
UMLS CUI [6]
C0005779
3. cont: diagnosed congenital bleeding disorders (von willebrand's disease) diagnosed acquired bleeding disorder w/in 1 year (acquired anti-factor viii antibodies);pts currently taking drugs that are generally accepted to have a risk of causing torsades de pointes including: quinidine, procainamide, disopyramide amiodarone, sotalol, ibutilide, dofetilide erythromycins, clarithromycin chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.
Beskrivning

Blood Coagulation Disorders | Torsades de points; Drug-induced

Datatyp

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2,1]
C3842160
UMLS CUI [2,2]
C0458082
4. patients with active, uncontrolled psychiatric disorders including: psychosis, major depression, and bipolar disorders
Beskrivning

Mental disorders; Unresponsive to Treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205269
5. 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.
Beskrivning

Pregnancy; Childbearing Potential; Contraceptive methods | Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0700589
UMLS CUI [2]
C0232970
6. continued: women must continue birth control for the duration of the trial and at least 3 months after the last dose of study drug; pregnant or breast-feeding women are excluded; all wocbp must have a negative pregnancy test 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.
Beskrivning

Contraceptive methods | Pregnancy | Breast Feeding | Pregnancy; Limited (extensiveness); Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C0032961
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C0021430
7. patients in late chronic phase (i.e., time from diagnosis to treatment >12 months), accelerated or blast phase are excluded.
Beskrivning

Leukemia, Myeloid, Chronic-Phase | Leukemia, Myeloid, Accelerated Phase | Blast Phase

Datatyp

boolean

Alias
UMLS CUI [1]
C0023474
UMLS CUI [2]
C0023472
UMLS CUI [3]
C0005699
8. the definitions of cml phases are as follows: a) early chronic phase: time from diagnosis to therapy </= 12 months; late chronic phase: time from diagnosis to therapy > 12 months, b) blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow, c) 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, •
Beskrivning

Myeloid Leukemia, Chronic; Phase

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023473
UMLS CUI [1,2]
C0205390
documented extramedullary blastic disease outside liver or spleen.
Beskrivning

Leukemia, blastic crisis (CML); Extramedullary

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0687162
UMLS CUI [1,2]
C1517060
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Similar models

Eligibility Chronic Myelogenous Leukemia NCT00254423

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Philadelphia Chromosome; BCR-ABL Fusion Gene; Myeloid Leukemia, Chronic | hydroxyurea | Interferon-alpha
Item
1. diagnosis of ph-positive or bcr-abl positive cml in early chronic phase cml (i.e., time from diagnosis </= 12 months). except for hydroxyurea, patients must have received no or minimal prior therapy, defined as <1 month (30 days) of prior ifn-alpha (with or without ara-c) and/or an fda approved tki
boolean
C0031526 (UMLS CUI [1,1])
C1835417 (UMLS CUI [1,2])
C0023473 (UMLS CUI [1,3])
C0020402 (UMLS CUI [2])
C0002199 (UMLS CUI [3])
2. Eligibility Determination | Clonal Evolution; Accelerated phase chronic myologenic leukemia
Item
2. continued from above #1: 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
C0013893 (UMLS CUI [1])
C1516669 (UMLS CUI [2,1])
C0919870 (UMLS CUI [2,2])
3. Age | Symptom burden score
Item
3. age >/= 16 years (age >18 years to participate in optional symptom burden assessment)
boolean
C0001779 (UMLS CUI [1])
C3533162 (UMLS CUI [2])
4. Eastern Cooperative Oncology Group
Item
4. ecog performance of 0-2
boolean
C1512162 (UMLS CUI [1])
5. Bilirubin, total measurement | Alanine Transaminase | Creatinine
Item
5. adequate end organ function, defined as the following: total bilirubin <1.5 x uln, sgpt <2.5x uln, creatinine <1.5x uln
boolean
C0201913 (UMLS CUI [1])
C0001899 (UMLS CUI [2])
C0010294 (UMLS CUI [3])
6. 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])
7. Provision of telephone | Clinical Trial Interactive Response Technology Documentation; Symptom burden score
Item
7. reliable telephone access to receive calls from an interactive voice response system (ivr) (only applicable to patients who will participate in optional symptom burden assessment)
boolean
C0729989 (UMLS CUI [1])
C3890944 (UMLS CUI [2,1])
C3533162 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
8. New York Heart Association Classification
Item
1. new york heart association (nyha) cardiac class 3-4 heart disease
boolean
C1275491 (UMLS CUI [1])
Angina Pectoris; Unresponsive to Treatment | Congenital long QT syndrome | Ventricular arrhythmia | Prolonged QTc interval | Uncontrolled hypertension | Blood Coagulation Disorders
Item
2. cardiac symptoms: patients meeting the following criteria are not eligible unless cleared by cardiology: uncontrolled angina within 3 months; diagnosed or suspected congenital long qt syndrome; any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes); prolonged qtc interval on pre-entry electrocardiogram (> 450 msec) on both the fridericia and bazett's correction; uncontrolled hypertension; history of significant bleeding disorder unrelated to cancer, including:
boolean
C0002962 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C1141890 (UMLS CUI [2])
C0085612 (UMLS CUI [3])
C1560305 (UMLS CUI [4])
C1868885 (UMLS CUI [5])
C0005779 (UMLS CUI [6])
Blood Coagulation Disorders | Torsades de points; Drug-induced
Item
3. cont: diagnosed congenital bleeding disorders (von willebrand's disease) diagnosed acquired bleeding disorder w/in 1 year (acquired anti-factor viii antibodies);pts currently taking drugs that are generally accepted to have a risk of causing torsades de pointes including: quinidine, procainamide, disopyramide amiodarone, sotalol, ibutilide, dofetilide erythromycins, clarithromycin chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.
boolean
C0005779 (UMLS CUI [1])
C3842160 (UMLS CUI [2,1])
C0458082 (UMLS CUI [2,2])
Mental disorders; Unresponsive to Treatment
Item
4. patients with active, uncontrolled psychiatric disorders including: psychosis, major depression, and bipolar disorders
boolean
C0004936 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
Pregnancy; Childbearing Potential; Contraceptive methods | Postmenopausal state
Item
5. 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.
boolean
C0032961 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0232970 (UMLS CUI [2])
Contraceptive methods | Pregnancy | Breast Feeding | Pregnancy; Limited (extensiveness); Informed Consent
Item
6. continued: women must continue birth control for the duration of the trial and at least 3 months after the last dose of study drug; pregnant or breast-feeding women are excluded; all wocbp must have a negative pregnancy test 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
C0700589 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0032961 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])
Leukemia, Myeloid, Chronic-Phase | Leukemia, Myeloid, Accelerated Phase | Blast Phase
Item
7. patients in late chronic phase (i.e., time from diagnosis to treatment >12 months), accelerated or blast phase are excluded.
boolean
C0023474 (UMLS CUI [1])
C0023472 (UMLS CUI [2])
C0005699 (UMLS CUI [3])
Myeloid Leukemia, Chronic; Phase
Item
8. the definitions of cml phases are as follows: a) early chronic phase: time from diagnosis to therapy </= 12 months; late chronic phase: time from diagnosis to therapy > 12 months, b) blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow, c) 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, •
boolean
C0023473 (UMLS CUI [1,1])
C0205390 (UMLS CUI [1,2])
Leukemia, blastic crisis (CML); Extramedullary
Item
documented extramedullary blastic disease outside liver or spleen.
boolean
C0687162 (UMLS CUI [1,1])
C1517060 (UMLS CUI [1,2])
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