ID

37684

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01788189

Stichworte

Versionen (2)
  1. 16.08.19 16.08.19 -
  2. 16.08.19 16.08.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

16. August 2019

DOI

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Creative Commons BY 4.0
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Eligibility B-cell Lymphoma NCT01788189

Englisch

Eligibility B-cell Lymphoma NCT01788189

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years
Beschreibung

Age

Datentyp

boolean

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

ECOG performance status

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Measurable Disease

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Comprehension Study Protocol | Protocol Compliance

Datentyp

boolean

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

Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
signed informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Central nervous system lymphoma Aggressive Relapse

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Condition Interferes with Interpretation Research data

Datentyp

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:
Beschreibung

Organ function Inadequate | Relationship Absent Aggressive Lymphoma

Datentyp

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
Beschreibung

Neutrophil count

Datentyp

boolean

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

Platelet Count measurement

Datentyp

boolean

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

Creatinine clearance measurement

Datentyp

boolean

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

Bilirubin measurement

Datentyp

boolean

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

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility B-cell Lymphoma NCT01788189

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