Information:
Fel:
ID
14355
Beskrivning
Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01404949
Länk
https://clinicaltrials.gov/show/NCT01404949
Nyckelord
Versioner (1)
- 2016-04-12 2016-04-12 -
Uppladdad den
12 april 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Acute Promyelocytic Leukemia NCT01404949
Eligibility Acute Promyelocytic Leukemia NCT01404949
- StudyEvent: Eligibility
Similar models
Eligibility Acute Promyelocytic Leukemia NCT01404949
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
APL
Item
previously untreated patients with a morphologic diagnosis of apl, confirmed by demonstration of t(15;17) using conventional cytogenetics or florescence in situ hybridization (fish), or a positive rt-pcr assay for pml-rar at the subject's local institution.
boolean
C0023487 (UMLS CUI [1])
Age and Karnofsky Performance Status
Item
age ≥18 years. karnofsky performance status of ≥ 60%.
boolean
C0001779 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
C0206065 (UMLS CUI [2])
Renal function
Item
adequate renal function as demonstrated by a serum creatinine ≤ 2.0 mg/dl or a creatinine clearance of > 60 ml/min.
boolean
C0232804 (UMLS CUI [1])
hepatic function
Item
adequate hepatic function as demonstrated by a bilirubin < 2.0 mg/dl (unless attributable to gilbert's disease) and an alkaline phosphatase, ast, and alt ≤ 2.5 times the upper limit of normal.
boolean
C0232741 (UMLS CUI [1])
cardiac function
Item
normal cardiac function as demonstrated by a left ventricular ejection fraction ≥ 50% on echocardiogram or muga scan.
boolean
C0232164 (UMLS CUI [1])
QTc
Item
qtc ≤ 500 msec on baseline ecg.
boolean
C0860814 (UMLS CUI [1])
Serum pregnancy test negative
Item
negative serum pregnancy test in women of childbearing potential.
boolean
C0430061 (UMLS CUI [1])
oral medication
Item
ability to swallow oral medication.
boolean
C0175795 (UMLS CUI [1])
Contraceptive methods
Item
men and women of child-bearing potential must be willing to practice an effective method of birth control during treatment and at least 4 months after treatment is finished.
boolean
C0700589 (UMLS CUI [1])
Therapeutic radiology procedure
Item
patients with central nervous system involvement by apl are eligible and may receive concomitant treatment with radiation therapy and/or intrathecal chemotherapy in accordance with standard medical practice.
boolean
C1522449 (UMLS CUI [1])
Previous treatment
Item
previous treatment for apl, except tretinoin, which may be given for up to 7 days prior to study entry.
boolean
C0420262 (UMLS CUI [1])
Communicable Diseases
Item
active serious infections not controlled by antibiotics.
boolean
C0009450 (UMLS CUI [1])
Pregnant Women
Item
pregnant women or women who are breast-feeding.
boolean
C0033011 (UMLS CUI [1])
Malignant Neoplasms
Item
concurrent active malignancy requiring immediate therapy.
boolean
C0006826 (UMLS CUI [1])
Heart Diseases
Item
clinically significant cardiac disease (ny heart association class iii or iv), including chronic arrhythmias, or pulmonary disease.
boolean
C0018799 (UMLS CUI [1])
Life Threatening Adverse Event
Item
other serious or life-threatening conditions deemed unacceptable by the principal investigator.
boolean
C1517874 (UMLS CUI [1])