ID

36297

Beschreibung

Optimal Dose Finding Study ABT-199 and Ibrutinib in MCL; ODM derived from: https://clinicaltrials.gov/show/NCT02419560

Link

https://clinicaltrials.gov/show/NCT02419560

Stichworte

Versionen (1)
  1. 30.04.19 30.04.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

30. April 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Lymphoma, Mantle-Cell NCT02419560

Englisch

Eligibility Lymphoma, Mantle-Cell NCT02419560

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosed with mantle cell lymphoma and has had at least one chemotherapy.
Beschreibung

Mantle cell lymphoma | Chemotherapy Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C0334634
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1265611
2. subjects must have measurable or evaluable disease.
Beschreibung

Measurable Disease | Evaluable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
3. ecog performance status of 0-2.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
4. must be referred for treatment with ibrutinib.
Beschreibung

Ibrutinib

Datentyp

boolean

Alias
UMLS CUI [1]
C3501358
5. must have adequate organ function.
Beschreibung

Organ function

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subject is pregnant.
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
2. prior malignancy (except nonmelanomatous skin cancer) unless disease free for a minimum of 2 years; non-invasive conditions such as carcinoma in situ of the breast, oral cavity, or cervix are all permissible.
Beschreibung

Malignant Neoplasms | Exception Skin carcinoma | Exception Disease Free Duration | Carcinoma in situ of female breast allowed | Carcinoma in situ of oral cavity allowed | Carcinoma in situ of uterine cervix allowed

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
UMLS CUI [3,4]
C0449238
UMLS CUI [4,1]
C0686288
UMLS CUI [4,2]
C0683607
UMLS CUI [5,1]
C0347073
UMLS CUI [5,2]
C0683607
UMLS CUI [6,1]
C0851140
UMLS CUI [6,2]
C0683607
3. known cns lymphoma.
Beschreibung

Central nervous system lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0742472
4. prior or current treatment with certain medications. talk to study contact for specifics.
Beschreibung

Pharmaceutical Preparations Specific

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205369
5. subject is at high risk for tls.
Beschreibung

High risk of Tumor Lysis Syndrome

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0041364
6. subject has malabsorption syndrome or other condition which may affect an enteral route of administration.
Beschreibung

Malabsorption Syndrome Affecting Enteral Route of Drug Administration | Condition Affecting Enteral Route of Drug Administration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024523
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1522196
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C1522196
7. subject has known contraindication or allergy to both xanthine oxidase inhibitors and rasburicase.
Beschreibung

Medical contraindication Xanthine Oxidase Inhibitors | Xanthine oxidase inhibitor allergy | Medical contraindication Rasburicase | Hypersensitivity Rasburicase

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0302609
UMLS CUI [2]
C0571135
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0937932
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0937932
8. significant history of heart disease.
Beschreibung

Heart Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
9. subject has an active infection.
Beschreibung

Communicable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
10. known active hepatitis b or hepatitis c.
Beschreibung

Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
11. a serious uncontrolled medical disorder that in the opinion of the investigator would impair the ability of the subject to receive protocol therapy.
Beschreibung

Disease Serious Uncontrolled | Therapy Receive Impaired

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C0221099
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Lymphoma, Mantle-Cell NCT02419560

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Mantle cell lymphoma | Chemotherapy Quantity
Item
1. diagnosed with mantle cell lymphoma and has had at least one chemotherapy.
boolean
C0334634 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Measurable Disease | Evaluable Disease
Item
2. subjects must have measurable or evaluable disease.
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
ECOG performance status
Item
3. ecog performance status of 0-2.
boolean
C1520224 (UMLS CUI [1])
Ibrutinib
Item
4. must be referred for treatment with ibrutinib.
boolean
C3501358 (UMLS CUI [1])
Organ function
Item
5. must have adequate organ function.
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
1. subject is pregnant.
boolean
C0032961 (UMLS CUI [1])
Malignant Neoplasms | Exception Skin carcinoma | Exception Disease Free Duration | Carcinoma in situ of female breast allowed | Carcinoma in situ of oral cavity allowed | Carcinoma in situ of uterine cervix allowed
Item
2. prior malignancy (except nonmelanomatous skin cancer) unless disease free for a minimum of 2 years; non-invasive conditions such as carcinoma in situ of the breast, oral cavity, or cervix are all permissible.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C0449238 (UMLS CUI [3,4])
C0686288 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C0347073 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C0851140 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
Central nervous system lymphoma
Item
3. known cns lymphoma.
boolean
C0742472 (UMLS CUI [1])
Pharmaceutical Preparations Specific
Item
4. prior or current treatment with certain medications. talk to study contact for specifics.
boolean
C0013227 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
High risk of Tumor Lysis Syndrome
Item
5. subject is at high risk for tls.
boolean
C0332167 (UMLS CUI [1,1])
C0041364 (UMLS CUI [1,2])
Malabsorption Syndrome Affecting Enteral Route of Drug Administration | Condition Affecting Enteral Route of Drug Administration
Item
6. subject has malabsorption syndrome or other condition which may affect an enteral route of administration.
boolean
C0024523 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1522196 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1522196 (UMLS CUI [2,3])
Medical contraindication Xanthine Oxidase Inhibitors | Xanthine oxidase inhibitor allergy | Medical contraindication Rasburicase | Hypersensitivity Rasburicase
Item
7. subject has known contraindication or allergy to both xanthine oxidase inhibitors and rasburicase.
boolean
C1301624 (UMLS CUI [1,1])
C0302609 (UMLS CUI [1,2])
C0571135 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0937932 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0937932 (UMLS CUI [4,2])
Heart Disease
Item
8. significant history of heart disease.
boolean
C0018799 (UMLS CUI [1])
Communicable Disease
Item
9. subject has an active infection.
boolean
C0009450 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
10. known active hepatitis b or hepatitis c.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Disease Serious Uncontrolled | Therapy Receive Impaired
Item
11. a serious uncontrolled medical disorder that in the opinion of the investigator would impair the ability of the subject to receive protocol therapy.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C0221099 (UMLS CUI [2,3])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video