Eligibility Leukemia NCT01570868

1 Formulare

StudyEvent: Eligibility
1. Eligibility Leukemia NCT01570868

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Inclusion Criteria

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])

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])

Exclusion Criteria

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])

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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Eligibility Leukemia NCT01570868