ID

41201

Beskrivning

A Study of MabThera/Rituxan (Rituximab) in Combination With Fludarabine And Cyclophosphamide as Primary Therapy in Elderly Patients With Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01263704

Länk

https://clinicaltrials.gov/show/NCT01263704

Nyckelord

Versioner (1)
  1. 2020-07-12 2020-07-12 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

12 juli 2020

DOI

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Creative Commons BY 4.0
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Eligibility Lymphocytic Leukemia, Chronic NCT01263704

Engelsk

Eligibility Lymphocytic Leukemia, Chronic NCT01263704

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/= 65 years of age
Beskrivning

Adult | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
previously untreated b-cell chronic lymphocytic leukemia (cll)
Beskrivning

B-cell chronic lymphocytic leukemia Untreated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475774
UMLS CUI [1,2]
C0332155
binet stage c or active binet stage a and b disease
Beskrivning

Binet Staging System

Datatyp

boolean

Alias
UMLS CUI [1]
C1511118
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment for cll
Beskrivning

Prior Therapy Chronic Lymphocytic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0023434
cll with transformation (richter's syndrome)
Beskrivning

Chronic Lymphocytic Leukemia | Richter's syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2]
C0349631
suspected or known cns involvement of cll
Beskrivning

Central Nervous System Involvement Chronic Lymphocytic Leukemia Suspected | Central Nervous System Involvement Chronic Lymphocytic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0023434
UMLS CUI [1,3]
C0750491
UMLS CUI [2,1]
C4050309
UMLS CUI [2,2]
C0023434
impaired renal or hepatic function
Beskrivning

Renal Insufficiency | Liver Dysfunction

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0086565
hiv positivity, active hepatitis b/c or hbv surface antigen positive, or any active or uncontrolled infections
Beskrivning

HIV Seropositivity | Hepatitis B | Hepatitis C | Hepatitis B surface antigen positive | Communicable Disease | Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0149709
UMLS CUI [5]
C0009450
UMLS CUI [6,1]
C0009450
UMLS CUI [6,2]
C0205318
patients with anti-hbv core antibodies (past infection with hbv) but who are negative for hbvsag (either anti-hbs ab positive or negative) and are positive for hbv-dna by pcr analysis
Beskrivning

Antibody to hepatitis B core antigen | Hepatitis B In the past | Hepatitis B surface antigen negative | Hepatitis B surface antibody positive | Hepatitis B surface antigen negative | Hepatitis B DNA Positive Polymerase Chain Reaction

Datatyp

boolean

Alias
UMLS CUI [1]
C0312631
UMLS CUI [2,1]
C0019163
UMLS CUI [2,2]
C1444637
UMLS CUI [3]
C0919711
UMLS CUI [4]
C0149708
UMLS CUI [5]
C0919711
UMLS CUI [6,1]
C5206277
UMLS CUI [6,2]
C0032520
concomitant diseases requiring chronic steroid administration
Beskrivning

Comorbidity Requirement Steroid therapy chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0149783
UMLS CUI [1,4]
C0205191
active second malignancy within the 2 years prior to study (except for non-melanoma skin cancer and in situ cervix or breast or prostate carcinoma)
Beskrivning

Second Primary Cancer | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Exception Carcinoma in situ of prostate

Datatyp

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0686288
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0154088
ecog performance status >/= 3
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
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Similar models

Eligibility Lymphocytic Leukemia, Chronic NCT01263704

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/= 65 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
B-cell chronic lymphocytic leukemia Untreated
Item
previously untreated b-cell chronic lymphocytic leukemia (cll)
boolean
C0475774 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Binet Staging System
Item
binet stage c or active binet stage a and b disease
boolean
C1511118 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Chronic Lymphocytic Leukemia
Item
prior treatment for cll
boolean
C1514463 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
Chronic Lymphocytic Leukemia | Richter's syndrome
Item
cll with transformation (richter's syndrome)
boolean
C0023434 (UMLS CUI [1])
C0349631 (UMLS CUI [2])
Central Nervous System Involvement Chronic Lymphocytic Leukemia Suspected | Central Nervous System Involvement Chronic Lymphocytic Leukemia
Item
suspected or known cns involvement of cll
boolean
C4050309 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C0750491 (UMLS CUI [1,3])
C4050309 (UMLS CUI [2,1])
C0023434 (UMLS CUI [2,2])
Renal Insufficiency | Liver Dysfunction
Item
impaired renal or hepatic function
boolean
C1565489 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
HIV Seropositivity | Hepatitis B | Hepatitis C | Hepatitis B surface antigen positive | Communicable Disease | Communicable Disease Uncontrolled
Item
hiv positivity, active hepatitis b/c or hbv surface antigen positive, or any active or uncontrolled infections
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0149709 (UMLS CUI [4])
C0009450 (UMLS CUI [5])
C0009450 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
Antibody to hepatitis B core antigen | Hepatitis B In the past | Hepatitis B surface antigen negative | Hepatitis B surface antibody positive | Hepatitis B surface antigen negative | Hepatitis B DNA Positive Polymerase Chain Reaction
Item
patients with anti-hbv core antibodies (past infection with hbv) but who are negative for hbvsag (either anti-hbs ab positive or negative) and are positive for hbv-dna by pcr analysis
boolean
C0312631 (UMLS CUI [1])
C0019163 (UMLS CUI [2,1])
C1444637 (UMLS CUI [2,2])
C0919711 (UMLS CUI [3])
C0149708 (UMLS CUI [4])
C0919711 (UMLS CUI [5])
C5206277 (UMLS CUI [6,1])
C0032520 (UMLS CUI [6,2])
Comorbidity Requirement Steroid therapy chronic
Item
concomitant diseases requiring chronic steroid administration
boolean
C0009488 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0149783 (UMLS CUI [1,3])
C0205191 (UMLS CUI [1,4])
Second Primary Cancer | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Exception Carcinoma in situ of prostate
Item
active second malignancy within the 2 years prior to study (except for non-melanoma skin cancer and in situ cervix or breast or prostate carcinoma)
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0686288 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0154088 (UMLS CUI [5,2])
ECOG performance status
Item
ecog performance status >/= 3
boolean
C1520224 (UMLS CUI [1])
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