ID

37248

Beschreibung

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

Stichworte

Versionen (2)
  1. 11.07.19 11.07.19 -
  2. 11.07.19 11.07.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

11. Juli 2019

DOI

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Lizenz

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

Englisch

Eligibility Systemic Anaplastic Large-Cell Lymphoma NCT02487316

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

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

Datentyp

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
Beschreibung

ECOG performance status

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Survival time Estimated

Datentyp

boolean

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

Age

Datentyp

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
Beschreibung

Childbearing Potential Pregnancy test negative | Gender Contraceptive methods

Datentyp

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
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
age <\ 18years
Beschreibung

Age

Datentyp

boolean

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

ALK-Positive Primary Systemic Anaplastic Large Cell Lymphoma Absent

Datentyp

boolean

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

Measurable lesion Absent

Datentyp

boolean

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

Study Subject Participation Status | Investigational New Drugs

Datentyp

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
Beschreibung

Pregnancy Contraceptive methods Unwilling | Breast Feeding Contraceptive methods Unwilling

Datentyp

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
Beschreibung

Hepatic Insufficiency | SERUM TOTAL BILIRUBIN ELEVATED | Alanine aminotransferase increased

Datentyp

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
Beschreibung

Renal Insufficiency | Serum creatinine raised

Datentyp

boolean

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

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

Datentyp

boolean

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

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
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Ähnliche Modelle

Eligibility Systemic Anaplastic Large-Cell Lymphoma NCT02487316

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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