ID

37248

Descrição

A Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib; ODM derived from: https://clinicaltrials.gov/show/NCT02487316

Link

https://clinicaltrials.gov/show/NCT02487316

Palavras-chave

Versões (2)
  1. 11/07/2019 11/07/2019 -
  2. 11/07/2019 11/07/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

11 de julho de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Systemic Anaplastic Large-Cell Lymphoma NCT02487316

Inglês

Eligibility Systemic Anaplastic Large-Cell Lymphoma NCT02487316

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
primary alk(+) system diffuse large b-cell lymphoma histologically confirmed by biopsy without therapy
Descrição

ALK-Positive Primary Systemic Anaplastic Large Cell Lymphoma Biopsy | Therapy Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1335492
UMLS CUI [1,2]
C0005558
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0332197
ecog 0-2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
more than 1 measurable lesions with major axis >1.5cm and minor axis>1.0cm
Descrição

Measurable lesion Quantity | Measurable lesion Major Axis | Measurable lesion Minor Axis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1295723
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C1295724
estimated survival >/3months
Descrição

Survival time Estimated

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2919552
UMLS CUI [1,2]
C0750572
age 18-65 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
women of childbearing age should have a negative pregnancy test; men and women who need to agree to use effective contraception during the period of treatment and the following 1 years
Descrição

Childbearing Potential Pregnancy test negative | Gender Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
signature of informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
age <\ 18years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
without alk(+) system diffuse large b-cell lymphoma histologically confirmed by biopsy
Descrição

ALK-Positive Primary Systemic Anaplastic Large Cell Lymphoma Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1335492
UMLS CUI [1,2]
C0332197
without measurable lesions
Descrição

Measurable lesion Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0332197
being treated by other drugs in other clinical trials
Descrição

Study Subject Participation Status | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
pregnant or lactating women, who are not willing to take contraceptive measures during the study period, or are not willing to use effective contraceptive measures during the period of treatment and the following 1 years
Descrição

Pregnancy Contraceptive methods Unwilling | Breast Feeding Contraceptive methods Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
hepatic insufficiency: serum total bilirubin, alt more than 2 times higher than normal
Descrição

Hepatic Insufficiency | SERUM TOTAL BILIRUBIN ELEVATED | Alanine aminotransferase increased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1306571
UMLS CUI [2]
C0595866
UMLS CUI [3]
C0151905
renal insufficiency: more than 2 times higher than that of normal serum creatinine
Descrição

Renal Insufficiency | Serum creatinine raised

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0700225
blood screening period: wbc < 1 * 109/l * 109/l; platelet < 25; hb < 60g/l
Descrição

Blood Screening | White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1511226
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
hiv test positive
Descrição

HIV Seropositivity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
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Similar models

Eligibility Systemic Anaplastic Large-Cell Lymphoma NCT02487316

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
ALK-Positive Primary Systemic Anaplastic Large Cell Lymphoma Biopsy | Therapy Absent
Item
primary alk(+) system diffuse large b-cell lymphoma histologically confirmed by biopsy without therapy
boolean
C1335492 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
ECOG performance status
Item
ecog 0-2
boolean
C1520224 (UMLS CUI [1])
Measurable lesion Quantity | Measurable lesion Major Axis | Measurable lesion Minor Axis
Item
more than 1 measurable lesions with major axis >1.5cm and minor axis>1.0cm
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C1295723 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3,1])
C1295724 (UMLS CUI [3,2])
Survival time Estimated
Item
estimated survival >/3months
boolean
C2919552 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
Age
Item
age 18-65 years
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Gender Contraceptive methods
Item
women of childbearing age should have a negative pregnancy test; men and women who need to agree to use effective contraception during the period of treatment and the following 1 years
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Informed Consent
Item
signature of informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
age <\ 18years
boolean
C0001779 (UMLS CUI [1])
ALK-Positive Primary Systemic Anaplastic Large Cell Lymphoma Absent
Item
without alk(+) system diffuse large b-cell lymphoma histologically confirmed by biopsy
boolean
C1335492 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Measurable lesion Absent
Item
without measurable lesions
boolean
C1513041 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs
Item
being treated by other drugs in other clinical trials
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Pregnancy Contraceptive methods Unwilling | Breast Feeding Contraceptive methods Unwilling
Item
pregnant or lactating women, who are not willing to take contraceptive measures during the study period, or are not willing to use effective contraceptive measures during the period of treatment and the following 1 years
boolean
C0032961 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0006147 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Hepatic Insufficiency | SERUM TOTAL BILIRUBIN ELEVATED | Alanine aminotransferase increased
Item
hepatic insufficiency: serum total bilirubin, alt more than 2 times higher than normal
boolean
C1306571 (UMLS CUI [1])
C0595866 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Renal Insufficiency | Serum creatinine raised
Item
renal insufficiency: more than 2 times higher than that of normal serum creatinine
boolean
C1565489 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
Blood Screening | White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement
Item
blood screening period: wbc < 1 * 109/l * 109/l; platelet < 25; hb < 60g/l
boolean
C1511226 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
HIV Seropositivity
Item
hiv test positive
boolean
C0019699 (UMLS CUI [1])
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