ID

13804

Descripción

A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01303796

Link

https://clinicaltrials.gov/show/NCT01303796

Palabras clave

Versiones (1)
  1. 7/3/16 7/3/16 -
Titular de derechos de autor

CC BY-NC 3.0

Subido en

7 de marzo de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT01303796

Inglés

Eligibility Acute Myeloid Leukemia NCT01303796

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed aml based on who classification
Descripción

AML

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023467
age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator
Descripción

Age, chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0392920
ecog performance status 0-2
Descripción

ECOG

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
adequate renal function
Descripción

renal function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232804
adequate liver function
Descripción

liver function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
able to swallow capsules
Descripción

ability to swallow capsules

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006935
UMLS CUI [1,2]
C0085732
agree to practice effective contraception
Descripción

contraception

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700589
ability to understand and willingness to sign the informed consent form
Descripción

informed consent form

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
aml is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
Descripción

APL or extramedullary tumor without bone marrow involvement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023487
UMLS CUI [2]
C1517677
UMLS CUI [3]
C1868812
having received any systemic anti-cancer therapy for aml or received treatment with hypomethylating agents or cytotoxic chemotherapy for the preceding mds or mpd
Descripción

anti-cancer therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C1531518
known or suspected central nervous system (cns) involvement by leukemia
Descripción

cns leukemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1332884
uncontrolled intercurrent illness
Descripción

comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
known hypersensitivity to decitabine
Descripción

hypersensitivity to decitabine

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0049065
known to be hiv-positive
Descripción

hiv

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019682
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Similar models

Eligibility Acute Myeloid Leukemia NCT01303796

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
newly diagnosed aml based on who classification
boolean
C0023467 (UMLS CUI [1])
Age, chemotherapy
Item
age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator
boolean
C0001779 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
ECOG
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
renal function
Item
adequate renal function
boolean
C0232804 (UMLS CUI [1])
liver function
Item
adequate liver function
boolean
C0232741 (UMLS CUI [1])
ability to swallow capsules
Item
able to swallow capsules
boolean
C0006935 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
contraception
Item
agree to practice effective contraception
boolean
C0700589 (UMLS CUI [1])
informed consent form
Item
ability to understand and willingness to sign the informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
APL or extramedullary tumor without bone marrow involvement
Item
aml is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
boolean
C0023487 (UMLS CUI [1])
C1517677 (UMLS CUI [2])
C1868812 (UMLS CUI [3])
anti-cancer therapy
Item
having received any systemic anti-cancer therapy for aml or received treatment with hypomethylating agents or cytotoxic chemotherapy for the preceding mds or mpd
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
cns leukemia
Item
known or suspected central nervous system (cns) involvement by leukemia
boolean
C1332884 (UMLS CUI [1])
comorbidity
Item
uncontrolled intercurrent illness
boolean
C0009488 (UMLS CUI [1])
hypersensitivity to decitabine
Item
known hypersensitivity to decitabine
boolean
C0020517 (UMLS CUI [1,1])
C0049065 (UMLS CUI [1,2])
hiv
Item
known to be hiv-positive
boolean
C0019682 (UMLS CUI [1])
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