ID

14023

Beschrijving

A Safety and Efficacy Study Using Decitabine, Decitabine/Carboplatin, Decitabine/Arsenic for the Treatment of Relapsed, Refractory, and Elderly Acute Myeloid Leukemia , Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02190695

Link

https://clinicaltrials.gov/show/NCT02190695

Trefwoorden

  1. 22-03-16 22-03-16 -
Geüploaded op

22 maart 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Acute Myeloid Leukemia NCT02190695

Eligibility Acute Myeloid Leukemia NCT02190695

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
acute myeloid leukemia, relapsed or refractory and elderly(over 65)
Beschrijving

Acute myeloid leukemia

Datatype

boolean

Alias
UMLS CUI [1]
C0023467
acute myeloid leukemia under 65 but who are unfit for conventional therapy
Beschrijving

Acute myeloid leukemia

Datatype

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C3839996
de novo or treated myelodysplastic syndrome, chronic myelomonocytic leukemia who are int-1or above
Beschrijving

Myelodysplastic syndrom

Datatype

boolean

Patients may have prior exposure to azacitidine but no decitabine
Beschrijving

Azacitidine

Datatype

boolean

Alias
UMLS CUI [1]
C0004475
Must be off all chemotherapy for 2 weeks and recovered from any toxicities unless rapidly progressive disease.
Beschrijving

Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0439577
Hydrea is permitted for first 4 cycles
Beschrijving

Hydrea

Datatype

boolean

Alias
UMLS CUI [1]
C0591617
Performance 0-2 (ecog)
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
Adequate cardiac functions assessed by 2d echo (nyha cardiac iii-iv excluded)
Beschrijving

Adequate cardiac function

Datatype

boolean

Alias
UMLS CUI [1]
C0438176
Pretreatment Electrocardiogram
Beschrijving

Electrocardiogram

Datatype

boolean

Alias
UMLS CUI [1]
C0013798
Lab results
Beschrijving

Lab results

Datatype

integer

Absence of significant intercurrent illness such as uncontrolled heart failure, unstable angina or cardiac arrhythmia
Beschrijving

Intercurrent illness

Datatype

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0002965
Psychiatric illness which precludes the giving of informed consent
Beschrijving

Psychiatric illness

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
Informed Consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
Nursing and pregnant females
Beschrijving

Pregnant

Datatype

boolean

Alias
UMLS CUI [1]
C0549206
Current uncontrolled infections
Beschrijving

uncontrolled infections

Datatype

boolean

Alias
UMLS CUI [1]
C3714514
Uncontrolled intercurrent illness including , but not limited to the above list
Beschrijving

Significant Intercurrent Illness

Datatype

boolean

Alias
UMLS CUI [1]
C3640977
Chronic kidney disease> stage 3
Beschrijving

Chronic kidney disease

Datatype

boolean

Alias
UMLS CUI [1]
C0022661
Hiv infection
Beschrijving

HIV Infections

Datatype

boolean

Alias
UMLS CUI [1]
C0019693

Similar models

Eligibility Acute Myeloid Leukemia NCT02190695

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Acute myeloid leukemia
Item
acute myeloid leukemia, relapsed or refractory and elderly(over 65)
boolean
C0023467 (UMLS CUI [1])
Acute myeloid leukemia
Item
acute myeloid leukemia under 65 but who are unfit for conventional therapy
boolean
C0023467 (UMLS CUI [1])
C3839996 (UMLS CUI [2])
Myelodysplastic syndrom
Item
de novo or treated myelodysplastic syndrome, chronic myelomonocytic leukemia who are int-1or above
boolean
Azacitidine
Item
Patients may have prior exposure to azacitidine but no decitabine
boolean
C0004475 (UMLS CUI [1])
Chemotherapy
Item
Must be off all chemotherapy for 2 weeks and recovered from any toxicities unless rapidly progressive disease.
boolean
C0439577 (UMLS CUI [1])
Hydrea
Item
Hydrea is permitted for first 4 cycles
boolean
C0591617 (UMLS CUI [1])
ECOG performance status
Item
Performance 0-2 (ecog)
boolean
C1520224 (UMLS CUI [1])
Adequate cardiac function
Item
Adequate cardiac functions assessed by 2d echo (nyha cardiac iii-iv excluded)
boolean
C0438176 (UMLS CUI [1])
Electrocardiogram
Item
Pretreatment Electrocardiogram
boolean
C0013798 (UMLS CUI [1])
Item
Lab results
integer
Code List
Lab results
CL Item
Creatinine (1)
C0010294 (UMLS CUI-1)
CL Item
Total billirubine (2)
C0005437 (UMLS CUI-1)
Intercurrent illness
Item
Absence of significant intercurrent illness such as uncontrolled heart failure, unstable angina or cardiac arrhythmia
boolean
C0018801 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
Psychiatric illness
Item
Psychiatric illness which precludes the giving of informed consent
boolean
C0004936 (UMLS CUI [1])
Informed Consent
Item
Informed Consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnant
Item
Nursing and pregnant females
boolean
C0549206 (UMLS CUI [1])
uncontrolled infections
Item
Current uncontrolled infections
boolean
C3714514 (UMLS CUI [1])
Significant Intercurrent Illness
Item
Uncontrolled intercurrent illness including , but not limited to the above list
boolean
C3640977 (UMLS CUI [1])
Chronic kidney disease
Item
Chronic kidney disease> stage 3
boolean
C0022661 (UMLS CUI [1])
HIV Infections
Item
Hiv infection
boolean
C0019693 (UMLS CUI [1])

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