Information:
Fel:
ID
14569
Beskrivning
Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01361464
Länk
https://clinicaltrials.gov/show/NCT01361464
Nyckelord
Versioner (1)
- 2016-04-21 2016-04-21 -
Uppladdad den
21 april 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Adult Acute Megakaryoblastic Leukemia NCT01361464
Eligibility Adult Acute Megakaryoblastic Leukemia NCT01361464
- StudyEvent: Eligibility
Similar models
Eligibility Adult Acute Megakaryoblastic Leukemia NCT01361464
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
aml
Item
previously untreated acute myeloid leukemia (aml) (de novo or secondary)
boolean
C0023467 (UMLS CUI [1])
acute promyelocytic leukemia
Item
no diagnosis of acute promyelocytic leukemia (apl)
boolean
C0023487 (UMLS CUI [1])
induction chemotherapy
Item
deemed unsuitable for or refuses standard induction chemotherapy
boolean
C0392920 (UMLS CUI [1])
RASGRP1 gene
Item
rasgrp1:aptx ratio >= 5, through bone marrow screening
boolean
C1419283 (UMLS CUI [1])
Central nervous system leukaemia
Item
no patients with known leukemic involvement of the central nervous system
boolean
C1332884 (UMLS CUI [1])
ecog performance status
Item
ecog performance status =< 2
boolean
C1520224 (UMLS CUI [1])
no wbc
Item
no wbc >= 30,000/ul (hydroxyurea permitted up to 24 hours prior to initiation of therapy)
boolean
C0023508 (UMLS CUI [1])
serum creatinine
Item
serum creatinine less than 1.5 times the upper limit of the normal range (uln) (national cancer institute [nci] common toxicity criteria [ctc] grade 1)
boolean
C0201976 (UMLS CUI [1])
total bilirubin
Item
total bilirubin less than 1.5 times uln (unless the increase is unequivocally due to hemolysis or gilbert syndrome)
boolean
C0201913 (UMLS CUI [1])
alt and ast
Item
alt and ast less than 2.5 times uln (nci ctc grade 1)
boolean
C0001899 (UMLS CUI [1,1])
C0004002 (UMLS CUI [1,2])
C0004002 (UMLS CUI [1,2])
contraception
Item
men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
boolean
C0420837 (UMLS CUI [1])
neuropathy
Item
no symptomatic neuropathy of grade 2 or worse
boolean
C0442874 (UMLS CUI [1])
intravascular coagulation
Item
no uncompensated disseminated intravascular coagulation (dic) or uncontrolled bleeding
boolean
C1410115 (UMLS CUI [1])
no history of allergic reactions
Item
no history of allergic reactions attributed to compounds of similar chemical or biologic composition to tipifarnib (r115777), such as the imidazole drugs, including clotrimazole, ketoconazole, miconazole, econazole, fenticonazole, isoconazole, sulconazole, ticonazole, or terconazole
boolean
C0020517 (UMLS CUI [1])
intercurrent illness
Item
no uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C3640977 (UMLS CUI [1])
hiv-positive patients
Item
known hiv-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with r115777; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; known hiv-positive patients not on antiretroviral therapy and with a cd4 cell count >= 400/mm^3 are eligible
boolean
C0019682 (UMLS CUI [1])
Cytotoxic Chemotherapy
Item
no other concurrent cytotoxic or biologic antileukemic therapy
boolean
C0677881 (UMLS CUI [1])
investigational agent
Item
no patients who are receiving any other investigational agents
boolean
C1875319 (UMLS CUI [1])
Anticonvulsants
Item
use of enzyme-inducing anticonvulsants (e.g., phenytoin, fosphenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine) while taking tipifarnib (r115777) is contraindicated
boolean
C0003286 (UMLS CUI [1])
non-enzyme-inducing anticonvulsants
Item
if clinically indicated, subjects may use non-enzyme-inducing anticonvulsants during treatment with r115777
boolean
C0003286 (UMLS CUI [1])