ID

44778

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01010373

Nyckelord

Versioner (3)
  1. 2015-09-01 2015-09-01 -
  2. 2021-04-13 2021-04-13 - Dr. rer. medic Philipp Neuhaus
  3. 2021-11-18 2021-11-18 -
Rättsinnehavare

BioMAS Ltd

Uppladdad den

18 november 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Acute Myeloid Leukemia NCT01010373

Engelsk

Eligibility Acute Myeloid Leukemia NCT01010373

1 Formulär  
Inclusion Criteria
Beskrivning

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.
Beskrivning

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

Datatyp

boolean

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

age

Datatyp

boolean

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

ecog performance status

Datatyp

boolean

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

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

Datatyp

boolean

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

hepatic function; serum; ast; uln; alt

Datatyp

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.
Beskrivning

contraceptive; method; study

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

patients receiving any other investigational agents.
Beskrivning

other; agents

Datatyp

boolean

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

cns involvement; symptomatic

Datatyp

boolean

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

alcohol abuse; pancreatitis; active

Datatyp

boolean

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

diagnosis; fab

Datatyp

boolean

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

life expectancy

Datatyp

boolean

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

Mylotarg

Datatyp

boolean

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

growth factors; treatment; g-csf; week

Datatyp

boolean

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

pregnant or lactating

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

boolean

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

Eligibility Acute Myeloid Leukemia NCT01010373

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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