ID

14569

Descripción

Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01361464

Link

https://clinicaltrials.gov/show/NCT01361464

Palabras clave

Versiones (1)
  1. 21/4/16 21/4/16 -
Subido en

21 de abril de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Adult Acute Megakaryoblastic Leukemia NCT01361464

Inglés

Eligibility Adult Acute Megakaryoblastic Leukemia NCT01361464

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
previously untreated acute myeloid leukemia (aml) (de novo or secondary)
Descripción

aml

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023467
no diagnosis of acute promyelocytic leukemia (apl)
Descripción

acute promyelocytic leukemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023487
deemed unsuitable for or refuses standard induction chemotherapy
Descripción

induction chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0392920
rasgrp1:aptx ratio >= 5, through bone marrow screening
Descripción

RASGRP1 gene

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1419283
no patients with known leukemic involvement of the central nervous system
Descripción

Central nervous system leukaemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1332884
ecog performance status =< 2
Descripción

ecog performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
no wbc >= 30,000/ul (hydroxyurea permitted up to 24 hours prior to initiation of therapy)
Descripción

no wbc

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023508
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)
Descripción

serum creatinine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
total bilirubin less than 1.5 times uln (unless the increase is unequivocally due to hemolysis or gilbert syndrome)
Descripción

total bilirubin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201913
alt and ast less than 2.5 times uln (nci ctc grade 1)
Descripción

alt and ast

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001899
UMLS CUI [1,2]
C0004002
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
Descripción

contraception

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0420837
no symptomatic neuropathy of grade 2 or worse
Descripción

neuropathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0442874
no uncompensated disseminated intravascular coagulation (dic) or uncontrolled bleeding
Descripción

intravascular coagulation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1410115
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
Descripción

no history of allergic reactions

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020517
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
Descripción

intercurrent illness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3640977
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
Descripción

hiv-positive patients

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019682
no other concurrent cytotoxic or biologic antileukemic therapy
Descripción

Cytotoxic Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0677881
no patients who are receiving any other investigational agents
Descripción

investigational agent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1875319
use of enzyme-inducing anticonvulsants (e.g., phenytoin, fosphenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine) while taking tipifarnib (r115777) is contraindicated
Descripción

Anticonvulsants

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003286
if clinically indicated, subjects may use non-enzyme-inducing anticonvulsants during treatment with r115777
Descripción

non-enzyme-inducing anticonvulsants

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003286
Volver a la parte superior de la página

Similar models

Eligibility Adult Acute Megakaryoblastic Leukemia NCT01361464

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial