ID

29270

Beschreibung

GCS-100LE in Combination With Etoposide and Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00776802

Link

https://clinicaltrials.gov/show/NCT00776802

Stichworte

Versionen (1)
  1. 14.03.18 14.03.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

14. März 2018

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 Diffuse Large B-cell Lymphoma NCT00776802

Englisch

Eligibility Diffuse Large B-cell Lymphoma NCT00776802

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients who are 18 years of age or older with diffuse large b-cell cell lymphoma (dlbcl) relapsed or refractory after initial therapy who:
Beschreibung

Age | Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory | Status post Therapeutic procedure Initial

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0855111
UMLS CUI [3]
C0855112
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C0205265
are not candidates for autologous stem cell transplant.
Beschreibung

Patients Inappropriate Autologous hematopoietic stem cell transplant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C2193200
have relapsed after autologous or allogeneic stem cell transplant.
Beschreibung

Recurrent disease Post Autologous hematopoietic stem cell transplant | Recurrent disease Post Allogeneic Stem Cell Transplantation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C2193200
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C2242529
have relapsed or refractory disease after 3 successive chemotherapy regimens.
Beschreibung

Recurrent disease Post Chemotherapy Regimen Quantity | Refractory Disease Post Chemotherapy Regimen Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0392920
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C1514815
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0392920
UMLS CUI [2,4]
C1265611
ecog performance score 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
creatinine clearance > 60 ml/min/1.73 m2.
Beschreibung

Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0373595
total bilirubin ≤2.0 x institutional upper limit of normal (iuln)
Beschreibung

SERUM TOTAL BILIRUBIN ELEVATED

Datentyp

boolean

Alias
UMLS CUI [1]
C0595866
ast (sgot)/alt (sgpt) ≤2.5 x iunl, or ≤5x iunl in patients with liver involvement of dlbcl
Beschreibung

Aspartate aminotransferase increased | Alanine aminotransferase increased | Relationship Hepatic Involvement Diffuse Large B-Cell Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0441932
UMLS CUI [3,3]
C0079744
absolute neutrophil count >1,000 /_l; hemoglobin >9 g/ml; platelet count > 75,000 /_l at screening.
Beschreibung

Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0032181
patients must be capable of understanding the purpose and risks of the study and able to provide written consent.
Beschreibung

Comprehension Study Protocol | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
patients must be willing and able to comply with the prescribed treatment protocol and evaluations
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with experimental (unlicensed) drug within 3 weeks of treatment.
Beschreibung

Experimental drug Without License

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0023636
previous chemotherapy, or major surgery within 21 days prior to first study treatment, or radiation therapy within 6 weeks.
Beschreibung

Prior Chemotherapy | Major surgery | Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0679637
UMLS CUI [3]
C1522449
rapidly progressive disease or organ function threatened by disease
Beschreibung

Rapidly progressive disorder | Organ function At risk of disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1850776
UMLS CUI [2,1]
C0678852
UMLS CUI [2,2]
C1281905
serious, uncontrolled active infections.
Beschreibung

Communicable Disease Serious Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
serologically positive for hiv, hbv, or hcv.
Beschreibung

HIV Seropositivity | HEPATITIS B SEROLOGY POSITIVE | Hepatitis C virus Serology positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0744838
UMLS CUI [3,1]
C0220847
UMLS CUI [3,2]
C0242089
clinically significant cardiac, pulmonary, and/or hepatic dysfunction
Beschreibung

Cardiac dysfunction | Pulmonary Dysfunction | Liver Dysfunction

Datentyp

boolean

Alias
UMLS CUI [1]
C3277906
UMLS CUI [2]
C1709770
UMLS CUI [3]
C0086565
lymphoma involving the central nervous system
Beschreibung

Lymphoma Central Nervous System Involvement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C4050309
female patients who are pregnant or breast feeding.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients not capable of understanding the purpose and risks of the study and or unable to provide written consent.
Beschreibung

Comprehension Study Protocol Unable | Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
patients not willing and or unable to comply with the prescribed treatment protocol and evaluations
Beschreibung

Protocol Compliance Unwilling | Protocol Compliance Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Diffuse Large B-cell Lymphoma NCT00776802

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory | Status post Therapeutic procedure Initial
Item
male or female patients who are 18 years of age or older with diffuse large b-cell cell lymphoma (dlbcl) relapsed or refractory after initial therapy who:
boolean
C0001779 (UMLS CUI [1])
C0855111 (UMLS CUI [2])
C0855112 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0205265 (UMLS CUI [4,3])
Patients Inappropriate Autologous hematopoietic stem cell transplant
Item
are not candidates for autologous stem cell transplant.
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C2193200 (UMLS CUI [1,3])
Recurrent disease Post Autologous hematopoietic stem cell transplant | Recurrent disease Post Allogeneic Stem Cell Transplantation
Item
have relapsed after autologous or allogeneic stem cell transplant.
boolean
C0277556 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C2193200 (UMLS CUI [1,3])
C0277556 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C2242529 (UMLS CUI [2,3])
Recurrent disease Post Chemotherapy Regimen Quantity | Refractory Disease Post Chemotherapy Regimen Quantity
Item
have relapsed or refractory disease after 3 successive chemotherapy regimens.
boolean
C0277556 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C1514815 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
ECOG performance status
Item
ecog performance score 0-2
boolean
C1520224 (UMLS CUI [1])
Creatinine clearance measurement
Item
creatinine clearance > 60 ml/min/1.73 m2.
boolean
C0373595 (UMLS CUI [1])
SERUM TOTAL BILIRUBIN ELEVATED
Item
total bilirubin ≤2.0 x institutional upper limit of normal (iuln)
boolean
C0595866 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Relationship Hepatic Involvement Diffuse Large B-Cell Lymphoma
Item
ast (sgot)/alt (sgpt) ≤2.5 x iunl, or ≤5x iunl in patients with liver involvement of dlbcl
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C0441932 (UMLS CUI [3,2])
C0079744 (UMLS CUI [3,3])
Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement
Item
absolute neutrophil count >1,000 /_l; hemoglobin >9 g/ml; platelet count > 75,000 /_l at screening.
boolean
C0948762 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Comprehension Study Protocol | Informed Consent
Item
patients must be capable of understanding the purpose and risks of the study and able to provide written consent.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Protocol Compliance
Item
patients must be willing and able to comply with the prescribed treatment protocol and evaluations
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Experimental drug Without License
Item
treatment with experimental (unlicensed) drug within 3 weeks of treatment.
boolean
C0304229 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0023636 (UMLS CUI [1,3])
Prior Chemotherapy | Major surgery | Therapeutic radiology procedure
Item
previous chemotherapy, or major surgery within 21 days prior to first study treatment, or radiation therapy within 6 weeks.
boolean
C1514457 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
Rapidly progressive disorder | Organ function At risk of disease
Item
rapidly progressive disease or organ function threatened by disease
boolean
C1850776 (UMLS CUI [1])
C0678852 (UMLS CUI [2,1])
C1281905 (UMLS CUI [2,2])
Communicable Disease Serious Uncontrolled
Item
serious, uncontrolled active infections.
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
HIV Seropositivity | HEPATITIS B SEROLOGY POSITIVE | Hepatitis C virus Serology positive
Item
serologically positive for hiv, hbv, or hcv.
boolean
C0019699 (UMLS CUI [1])
C0744838 (UMLS CUI [2])
C0220847 (UMLS CUI [3,1])
C0242089 (UMLS CUI [3,2])
Cardiac dysfunction | Pulmonary Dysfunction | Liver Dysfunction
Item
clinically significant cardiac, pulmonary, and/or hepatic dysfunction
boolean
C3277906 (UMLS CUI [1])
C1709770 (UMLS CUI [2])
C0086565 (UMLS CUI [3])
Lymphoma Central Nervous System Involvement
Item
lymphoma involving the central nervous system
boolean
C0024299 (UMLS CUI [1,1])
C4050309 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
female patients who are pregnant or breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comprehension Study Protocol Unable | Informed Consent Unable
Item
patients not capable of understanding the purpose and risks of the study and or unable to provide written consent.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
patients not willing and or unable to comply with the prescribed treatment protocol and evaluations
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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