ID

37684

Beskrivning

Lenalidomide, MTX, Ara-C and Rituximab in Relapsed Aggressive B-cell Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT01788189

Länk

https://clinicaltrials.gov/show/NCT01788189

Nyckelord

Versioner (2)
  1. 2019-08-16 2019-08-16 -
  2. 2019-08-16 2019-08-16 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 augusti 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility B-cell Lymphoma NCT01788189

Engelsk

Eligibility B-cell Lymphoma NCT01788189

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
performance status ecog 0 - 3
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
first or subsequent relapse or refractoriness of a biopsy-proven cd20-positive aggressive b cell lymphoma (excluding mantle cell lymphoma)
Beskrivning

Recurrent Aggressive Adult Non-Hodgkin Lymphoma B-Cell CD20 positive | Non-Hodgkin's lymphoma aggressive refractory B-Cell CD20 positive | Exception Mantle cell lymphoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677726
UMLS CUI [1,2]
C0004561
UMLS CUI [1,3]
C3888518
UMLS CUI [2,1]
C0854870
UMLS CUI [2,2]
C0004561
UMLS CUI [2,3]
C3888518
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0334634
measurable disease
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
ineligibility or unwillingness to undergo high-dose chemotherapy with autologous stem cell transplantation
Beskrivning

Ineligibility High-Dose Chemotherapy with Autologous Stem Cell Transplant | High-Dose Chemotherapy with Autologous Stem Cell Transplant Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C1512429
UMLS CUI [2,1]
C1512429
UMLS CUI [2,2]
C0558080
ability to understand the aim of the study and act accordingly
Beskrivning

Comprehension Study Protocol | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
effective contraception
Beskrivning

Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
signed informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
central nervous system relapse of aggressive lymphoma
Beskrivning

Central nervous system lymphoma Aggressive Relapse

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0280803
UMLS CUI [1,2]
C0580822
UMLS CUI [1,3]
C0205336
any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
Beskrivning

Medical condition Study Subject Participation Status Excluded | Laboratory test result abnormal Study Subject Participation Status Excluded | Mental disorder Study Subject Participation Status Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0332196
any condition including the presence of laboratory abnormalities which places the subject at unacceptable risk if he/she were to participate in the study
Beskrivning

Condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
any condition that confounds the ability to interpret data from the study
Beskrivning

Condition Interferes with Interpretation Research data

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0459471
UMLS CUI [1,4]
C0681873
inadequate organ function not related to aggressive lymphoma:
Beskrivning

Organ function Inadequate | Relationship Absent Aggressive Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0205412
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C1332225
neutrophils < 1.0/nl
Beskrivning

Neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0200633
platelets < 75/nl
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
creatinine clearance < 60 ml/min
Beskrivning

Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0373595
bilirubin ≥ 2,5 mg/dl
Beskrivning

Bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0344395
serum ast/got or alt/gpt ≥ 4 x upper limit of normal
Beskrivning

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
active viral hepatitis (hbv, hcv), hiv infection, any other uncontrolled infection
Beskrivning

Viral hepatitis | Hepatitis B | Hepatitis C | HIV Infection | Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1]
C0042721
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0019693
UMLS CUI [5,1]
C0009450
UMLS CUI [5,2]
C0205318
pregnancy and nursing period
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility B-cell Lymphoma NCT01788189

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
performance status ecog 0 - 3
boolean
C1520224 (UMLS CUI [1])
Recurrent Aggressive Adult Non-Hodgkin Lymphoma B-Cell CD20 positive | Non-Hodgkin's lymphoma aggressive refractory B-Cell CD20 positive | Exception Mantle cell lymphoma
Item
first or subsequent relapse or refractoriness of a biopsy-proven cd20-positive aggressive b cell lymphoma (excluding mantle cell lymphoma)
boolean
C0677726 (UMLS CUI [1,1])
C0004561 (UMLS CUI [1,2])
C3888518 (UMLS CUI [1,3])
C0854870 (UMLS CUI [2,1])
C0004561 (UMLS CUI [2,2])
C3888518 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0334634 (UMLS CUI [3,2])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
Ineligibility High-Dose Chemotherapy with Autologous Stem Cell Transplant | High-Dose Chemotherapy with Autologous Stem Cell Transplant Unwilling
Item
ineligibility or unwillingness to undergo high-dose chemotherapy with autologous stem cell transplantation
boolean
C1512714 (UMLS CUI [1,1])
C1512429 (UMLS CUI [1,2])
C1512429 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Comprehension Study Protocol | Protocol Compliance
Item
ability to understand the aim of the study and act accordingly
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Contraceptive methods
Item
effective contraception
boolean
C0700589 (UMLS CUI [1])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Central nervous system lymphoma Aggressive Relapse
Item
central nervous system relapse of aggressive lymphoma
boolean
C0280803 (UMLS CUI [1,1])
C0580822 (UMLS CUI [1,2])
C0205336 (UMLS CUI [1,3])
Medical condition Study Subject Participation Status Excluded | Laboratory test result abnormal Study Subject Participation Status Excluded | Mental disorder Study Subject Participation Status Excluded
Item
any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
Condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk
Item
any condition including the presence of laboratory abnormalities which places the subject at unacceptable risk if he/she were to participate in the study
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
Condition Interferes with Interpretation Research data
Item
any condition that confounds the ability to interpret data from the study
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,3])
C0681873 (UMLS CUI [1,4])
Organ function Inadequate | Relationship Absent Aggressive Lymphoma
Item
inadequate organ function not related to aggressive lymphoma:
boolean
C0678852 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0439849 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1332225 (UMLS CUI [2,3])
Neutrophil count
Item
neutrophils < 1.0/nl
boolean
C0200633 (UMLS CUI [1])
Platelet Count measurement
Item
platelets < 75/nl
boolean
C0032181 (UMLS CUI [1])
Creatinine clearance measurement
Item
creatinine clearance < 60 ml/min
boolean
C0373595 (UMLS CUI [1])
Bilirubin measurement
Item
bilirubin ≥ 2,5 mg/dl
boolean
C0344395 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
serum ast/got or alt/gpt ≥ 4 x upper limit of normal
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Viral hepatitis | Hepatitis B | Hepatitis C | HIV Infection | Communicable Disease Uncontrolled
Item
active viral hepatitis (hbv, hcv), hiv infection, any other uncontrolled infection
boolean
C0042721 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0019693 (UMLS CUI [4])
C0009450 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
Pregnancy | Breast Feeding
Item
pregnancy and nursing period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Tillbaka till toppen 

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