ID

14001

Beschrijving

the Effects and Safety of Idarubicin-strengthened Pretreatment Program and Conventional Busulfan Cyclophosphamide Pretreatment Program on High-risk Acute Myeloid Leukemia Patient; ODM derived from: https://clinicaltrials.gov/show/NCT01766375

Link

https://clinicaltrials.gov/show/NCT01766375

Trefwoorden

  1. 21-03-16 21-03-16 -
Geüploaded op

21 maart 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Acute Myeloid Leukemia NCT01766375

Eligibility Acute Myeloid Leukemia NCT01766375

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
Age: 18~50
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Received peripheral blood hematopoietic stem cell transplantation from siblings or unrelated allogeneic donors with identical matching of hla or 1 alleles mismatched.
Beschrijving

Peripheral Stem Cell Transplantation

Datatype

boolean

Alias
UMLS CUI [1]
C0242602
Diagnosis: refer to 2011 edition of aml china guideline for the diagnosis and treatment and diagnosis standards of high-risk acute myeloid leukemia developed through literatures (see appendix b);
Beschrijving

Acute Erythroblastic Leukemia

Datatype

boolean

Alias
UMLS CUI [1]
C0023440
Under general condition, ecog score ≤ 1;
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
Normal cardiac functions
Beschrijving

Cardiac function

Datatype

boolean

Normal liver and renal function: blood bilirubin≤35 μ mol\/l, ast/alt lower than twice in the upper limit of normal value, serum creatinine≤ 150 μ mol\/l;
Beschrijving

Renal and Liver function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
Subjects have signed the informed consent form.
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
Severe uncontrolled infection before transplantation;
Beschrijving

Infection

Datatype

boolean

Alias
UMLS CUI [1]
C3714514
With contraindications of idarubicin
Beschrijving

Idarubicin

Datatype

boolean

Alias
UMLS CUI [1]
C0020789
Reached the maximum cumulative dose of anthracyclines, for instance, dnr≥ 450mg/m2, mitoxantrone≥140mg/m2, the total cumulative dose of idarubicin≥ 300mg/m2;
Beschrijving

Anthracycline Antibiotics

Datatype

boolean

Alias
UMLS CUI [1]
C0003234
The other conditions that do not meet the inclusion criteria.
Beschrijving

Inclusion criteria

Datatype

boolean

Alias
UMLS CUI [1]
C2827031
Withdrawal criteria:
Beschrijving

Withdrawal

Datatype

integer

Alias
UMLS CUI [1]
C2349954

Similar models

Eligibility Acute Myeloid Leukemia NCT01766375

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
Age: 18~50
boolean
C0001779 (UMLS CUI [1])
Peripheral Stem Cell Transplantation
Item
Received peripheral blood hematopoietic stem cell transplantation from siblings or unrelated allogeneic donors with identical matching of hla or 1 alleles mismatched.
boolean
C0242602 (UMLS CUI [1])
Acute Erythroblastic Leukemia
Item
Diagnosis: refer to 2011 edition of aml china guideline for the diagnosis and treatment and diagnosis standards of high-risk acute myeloid leukemia developed through literatures (see appendix b);
boolean
C0023440 (UMLS CUI [1])
ECOG performance status
Item
Under general condition, ecog score ≤ 1;
boolean
C1520224 (UMLS CUI [1])
Cardiac function
Item
Normal cardiac functions
boolean
Renal and Liver function
Item
Normal liver and renal function: blood bilirubin≤35 μ mol\/l, ast/alt lower than twice in the upper limit of normal value, serum creatinine≤ 150 μ mol\/l;
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Informed consent
Item
Subjects have signed the informed consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Infection
Item
Severe uncontrolled infection before transplantation;
boolean
C3714514 (UMLS CUI [1])
Idarubicin
Item
With contraindications of idarubicin
boolean
C0020789 (UMLS CUI [1])
Anthracycline Antibiotics
Item
Reached the maximum cumulative dose of anthracyclines, for instance, dnr≥ 450mg/m2, mitoxantrone≥140mg/m2, the total cumulative dose of idarubicin≥ 300mg/m2;
boolean
C0003234 (UMLS CUI [1])
Inclusion criteria
Item
The other conditions that do not meet the inclusion criteria.
boolean
C2827031 (UMLS CUI [1])
Item
Withdrawal criteria:
integer
C2349954 (UMLS CUI [1])
Code List
Withdrawal criteria:
CL Item
Those do not meet the inclusion criteria or meet the exclusion criteria after reviewing (1)
C2827031 (UMLS CUI-1)
CL Item
Patient withdraws the informed consent form (2)
C0021430 (UMLS CUI-1)
CL Item
Patient violates the clinical study protocol (3)
C2348563 (UMLS CUI-1)
CL Item
Patient experiences severe adverse events that treatment has to be terminated (4)
C0877248 (UMLS CUI-1)
CL Item
Patient that considered no longer fit to complete clinical trials by researchers. (5)
C0525058 (UMLS CUI-1)

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