ID

29270

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00776802

Nyckelord

Versioner (1)
  1. 2018-03-14 2018-03-14 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

14 mars 2018

DOI

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Creative Commons BY 4.0
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Eligibility Diffuse Large B-cell Lymphoma NCT00776802

Engelsk

Eligibility Diffuse Large B-cell Lymphoma NCT00776802

1 Formulär  
Inclusion Criteria
Beskrivning

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:
Beskrivning

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

Datatyp

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.
Beskrivning

Patients Inappropriate Autologous hematopoietic stem cell transplant

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

ECOG performance status

Datatyp

boolean

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

Creatinine clearance measurement

Datatyp

boolean

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

SERUM TOTAL BILIRUBIN ELEVATED

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement

Datatyp

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.
Beskrivning

Comprehension Study Protocol | Informed Consent

Datatyp

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
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Experimental drug Without License

Datatyp

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.
Beskrivning

Prior Chemotherapy | Major surgery | Therapeutic radiology procedure

Datatyp

boolean

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

Rapidly progressive disorder | Organ function At risk of disease

Datatyp

boolean

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

Communicable Disease Serious Uncontrolled

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

Cardiac dysfunction | Pulmonary Dysfunction | Liver Dysfunction

Datatyp

boolean

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

Lymphoma Central Nervous System Involvement

Datatyp

boolean

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

Pregnancy | Breast Feeding

Datatyp

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.
Beskrivning

Comprehension Study Protocol Unable | Informed Consent Unable

Datatyp

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
Beskrivning

Protocol Compliance Unwilling | Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
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Similar models

Eligibility Diffuse Large B-cell Lymphoma NCT00776802

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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