ID

44778

Descrição

Safety and Efficacy Study of AS101 to Treat Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01010373

Link

https://clinicaltrials.gov/show/NCT01010373

Palavras-chave

Versões (3)
  1. 01/09/2015 01/09/2015 -
  2. 13/04/2021 13/04/2021 - Dr. rer. medic Philipp Neuhaus
  3. 18/11/2021 18/11/2021 -
Titular dos direitos

BioMAS Ltd

Transferido a

18 de novembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Acute Myeloid Leukemia NCT01010373

Inglês

Eligibility Acute Myeloid Leukemia NCT01010373

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

confirmed diagnosis of primary aml or aml transformed myelodysplastic syndrome (mds) with fab classification other than m3 as proven by bone marrow aspiration.
Descrição

myelodysplastic syndrome; bone marrow; diagnosis; aspiration; confirmed; other; primary; fab

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3463824
UMLS CUI [2]
C0023467
age ≥60 years.
Descrição

age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0-2 (karnofsky >60%).
Descrição

ecog performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
adequate renal functions: serum creatinine < 2 times the upper limit of normal (uln).
Descrição

upper limit of normal (sgpt); upper limit of normal (sgot); serum creatinine; renal function; uln

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232804
adequate hepatic function: serum ast and alt ≤ 3 x uln.
Descrição

hepatic function; serum; ast; uln; alt

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232741
patients with reproductive potential must use an effective contraceptive method through the study. patients must receive contraceptive and/or fertility counseling prior to entering the study, i.e., information on sperm banking, etc.
Descrição

contraceptive; method; study

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Descrição

Exclusion Criteria

patients receiving any other investigational agents.
Descrição

other; agents

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
symptomatic cns involvement.
Descrição

cns involvement; symptomatic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0449389
history of pancreatitis or active alcohol abuse.
Descrição

alcohol abuse; pancreatitis; active

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0030305
histologic diagnosis of fab m3 aml.
Descrição

diagnosis; fab

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023487
life expectancy of less than 1 month.
Descrição

life expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
patient receives myelotarg (ozogamicin gemtuzumab).
Descrição

Mylotarg

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0876099
use of hematopoietic growth factors such as g-csf within 1 week prior to treatment initiation.
Descrição

growth factors; treatment; g-csf; week

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079490
pregnant or lactating females.
Descrição

pregnant or lactating

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0549206
patient has known human immunodeficiency virus (hiv) infection or known hiv-related malignancy; patient has active hepatitis a, b or c infection.
Descrição

human immunodeficiency virus; active hepatitis; hepatitis a; malignancy; infection; related; hiv

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019159
UMLS CUI [3]
C0348211
active, uncontrolled, systemic infection considered opportunistic, life threatening, or of clinical significance at the time of treatment, or any severe concurrent disease which, in the opinion of the investigator, would make the patient inappropriate for trial entry.
Descrição

systemic infection; life threatening; investigator; treatment; clinical; disease; severe; active; entry; time

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0243026
UMLS CUI [2]
C1517874
the patient has had congestive heart failure - new york heart association (chf-nyha) grade ii or higher, and/or myocardial infarction within the last 12 months, or any cardiac disorder which, in the opinion of the investigator, could put the patient at risk of clinically relevant arrhythmia.
Descrição

new york heart association classification; congestive heart failure; myocardial infarction; cardiac disorder; investigator; arrhythmia; grade; last; chf

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0027051
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Similar models

Eligibility Acute Myeloid Leukemia NCT01010373

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
myelodysplastic syndrome; bone marrow; diagnosis; aspiration; confirmed; other; primary; fab
Item
confirmed diagnosis of primary aml or aml transformed myelodysplastic syndrome (mds) with fab classification other than m3 as proven by bone marrow aspiration.
boolean
C3463824 (UMLS CUI [1])
C0023467 (UMLS CUI [2])
age
Item
age ≥60 years.
boolean
C0001779 (UMLS CUI [1])
ecog performance status
Item
ecog performance status of 0-2 (karnofsky >60%).
boolean
C1520224 (UMLS CUI [1])
upper limit of normal (sgpt); upper limit of normal (sgot); serum creatinine; renal function; uln
Item
adequate renal functions: serum creatinine < 2 times the upper limit of normal (uln).
boolean
C0232804 (UMLS CUI [1])
hepatic function; serum; ast; uln; alt
Item
adequate hepatic function: serum ast and alt ≤ 3 x uln.
boolean
C0232741 (UMLS CUI [1])
contraceptive; method; study
Item
patients with reproductive potential must use an effective contraceptive method through the study. patients must receive contraceptive and/or fertility counseling prior to entering the study, i.e., information on sperm banking, etc.
boolean
C0700589 (UMLS CUI [1])
other; agents
Item
patients receiving any other investigational agents.
boolean
C0013230 (UMLS CUI [1])
cns involvement; symptomatic
Item
symptomatic cns involvement.
boolean
C0449389 (UMLS CUI [1])
alcohol abuse; pancreatitis; active
Item
history of pancreatitis or active alcohol abuse.
boolean
C0085762 (UMLS CUI [1])
C0030305 (UMLS CUI [2])
diagnosis; fab
Item
histologic diagnosis of fab m3 aml.
boolean
C0023487 (UMLS CUI [1])
life expectancy
Item
life expectancy of less than 1 month.
boolean
C0023671 (UMLS CUI [1])
Mylotarg
Item
patient receives myelotarg (ozogamicin gemtuzumab).
boolean
C0876099 (UMLS CUI [1])
growth factors; treatment; g-csf; week
Item
use of hematopoietic growth factors such as g-csf within 1 week prior to treatment initiation.
boolean
C0079490 (UMLS CUI [1])
pregnant or lactating
Item
pregnant or lactating females.
boolean
C0549206 (UMLS CUI [1])
human immunodeficiency virus; active hepatitis; hepatitis a; malignancy; infection; related; hiv
Item
patient has known human immunodeficiency virus (hiv) infection or known hiv-related malignancy; patient has active hepatitis a, b or c infection.
boolean
C0019682 (UMLS CUI [1])
C0019159 (UMLS CUI [2])
C0348211 (UMLS CUI [3])
systemic infection; life threatening; investigator; treatment; clinical; disease; severe; active; entry; time
Item
active, uncontrolled, systemic infection considered opportunistic, life threatening, or of clinical significance at the time of treatment, or any severe concurrent disease which, in the opinion of the investigator, would make the patient inappropriate for trial entry.
boolean
C0243026 (UMLS CUI [1])
C1517874 (UMLS CUI [2])
new york heart association classification; congestive heart failure; myocardial infarction; cardiac disorder; investigator; arrhythmia; grade; last; chf
Item
the patient has had congestive heart failure - new york heart association (chf-nyha) grade ii or higher, and/or myocardial infarction within the last 12 months, or any cardiac disorder which, in the opinion of the investigator, could put the patient at risk of clinically relevant arrhythmia.
boolean
C0018802 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
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