ID

41203

Beskrivning

A Study Comparing RO5072759 (GA101) 1000 mg Versus 2000 mg in Patients With Previously Untreated Chronic Lymphocytic Leukemia (GAGE); ODM derived from: https://clinicaltrials.gov/show/NCT01414205

Länk

https://clinicaltrials.gov/show/NCT01414205

Nyckelord

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

See clinicaltrials.gov

Uppladdad den

12 juli 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Lymphocytic Leukemia, Chronic NCT01414205

Engelsk

Eligibility Lymphocytic Leukemia, Chronic NCT01414205

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
cluster of differentiation antigen 20 (cd20)-positive b-cell chronic lymphocytic leukemia [per international workshop on chronic lymphocytic leukemia (iwcll) guidelines]
Beskrivning

B-cell chronic lymphocytic leukemia CD20 positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475774
UMLS CUI [1,2]
C3888518
rai stage iii/iv or binet stage c disease, or rai stage i/ii or binet stage b disease that requires treatment according to iwcll guidelines
Beskrivning

Disease Rai Staging System | Disease Binet Staging System | Treatment required

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1514715
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1511118
UMLS CUI [3]
C0332121
no previous treatment for cll chemotherapy, radiotherapy or immunotherapy; no previous rituximab treatment for autoimmune hemolytic anemia (aiha) or idiopathic thrombocytopenic purpura (itp); prior use of steroids for aiha or itp is allowed
Beskrivning

Chemotherapy Absent Chronic Lymphocytic Leukemia | Therapeutic radiology procedure Absent Chronic Lymphocytic Leukemia | Immunotherapy Absent Chronic Lymphocytic Leukemia | Rituximab Absent | Autoimmune hemolytic anemia | Acute idiopathic thrombocytopenic purpura

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0023434
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0023434
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0023434
UMLS CUI [4,1]
C0393022
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C0002880
UMLS CUI [6]
C0272292
eastern cooperative oncology group performance status of 0, 1 or 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
transformation of cll to aggressive b-cell malignancy
Beskrivning

Transformation Chronic Lymphocytic Leukemia | Transformation Aggressive cancer B-cell

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040682
UMLS CUI [1,2]
C0023434
UMLS CUI [2,1]
C0040682
UMLS CUI [2,2]
C2945759
UMLS CUI [2,3]
C0004561
history of severe allergic or anaphylactic reactions to monoclonal antibody therapy
Beskrivning

Allergic Reaction Severe Monoclonal Antibody Therapy | Anaphylaxis Severe Monoclonal Antibody Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0279694
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0279694
evidence of severe, uncontrolled concomitant disease
Beskrivning

Comorbidity Severe Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205318
known active infection or any major episode of infection requiring treatment with iv antibiotics or hospitalization within 4 weeks before the start of cycle 1
Beskrivning

Communicable Disease | Episode Major Communicable Disease | Requirement Antibiotics Intravenous | Hospitalization Required

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C0009450
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0003232
UMLS CUI [3,3]
C1522726
UMLS CUI [4]
C1708385
seropositive for human immunodeficiency virus (hiv)
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
positive for chronic hepatitis b infection (defined as positive hbsag serology)
Beskrivning

Chronic Hepatitis B Positive | Serology positive Hepatitis B Surface Antigens

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0524909
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0019168
positive for hepatitis c (hepatitis c virus [hcv] antibody serology testing)
Beskrivning

Hepatitis C positive | Hepatitis C Antibodies Serologic tests

Datatyp

boolean

Alias
UMLS CUI [1]
C1112419
UMLS CUI [2,1]
C0166049
UMLS CUI [2,2]
C0036743
pregnant or lactating women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
concurrent (or within 7 days prior to fist dose of study treatment) systemic corticosteroid use, except for low-dose corticosteroid therapy used to treat illness other than lymphoma
Beskrivning

Systemic Corticosteroid Therapy | Exception Steroid therapy Low dose

Datatyp

boolean

Alias
UMLS CUI [1]
C4053960
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0149783
UMLS CUI [2,3]
C0445550
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Similar models

Eligibility Lymphocytic Leukemia, Chronic NCT01414205

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
B-cell chronic lymphocytic leukemia CD20 positive
Item
cluster of differentiation antigen 20 (cd20)-positive b-cell chronic lymphocytic leukemia [per international workshop on chronic lymphocytic leukemia (iwcll) guidelines]
boolean
C0475774 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
Disease Rai Staging System | Disease Binet Staging System | Treatment required
Item
rai stage iii/iv or binet stage c disease, or rai stage i/ii or binet stage b disease that requires treatment according to iwcll guidelines
boolean
C0012634 (UMLS CUI [1,1])
C1514715 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C1511118 (UMLS CUI [2,2])
C0332121 (UMLS CUI [3])
Chemotherapy Absent Chronic Lymphocytic Leukemia | Therapeutic radiology procedure Absent Chronic Lymphocytic Leukemia | Immunotherapy Absent Chronic Lymphocytic Leukemia | Rituximab Absent | Autoimmune hemolytic anemia | Acute idiopathic thrombocytopenic purpura
Item
no previous treatment for cll chemotherapy, radiotherapy or immunotherapy; no previous rituximab treatment for autoimmune hemolytic anemia (aiha) or idiopathic thrombocytopenic purpura (itp); prior use of steroids for aiha or itp is allowed
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0023434 (UMLS CUI [2,3])
C0021083 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0023434 (UMLS CUI [3,3])
C0393022 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0002880 (UMLS CUI [5])
C0272292 (UMLS CUI [6])
ECOG performance status
Item
eastern cooperative oncology group performance status of 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Transformation Chronic Lymphocytic Leukemia | Transformation Aggressive cancer B-cell
Item
transformation of cll to aggressive b-cell malignancy
boolean
C0040682 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C0040682 (UMLS CUI [2,1])
C2945759 (UMLS CUI [2,2])
C0004561 (UMLS CUI [2,3])
Allergic Reaction Severe Monoclonal Antibody Therapy | Anaphylaxis Severe Monoclonal Antibody Therapy
Item
history of severe allergic or anaphylactic reactions to monoclonal antibody therapy
boolean
C1527304 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0279694 (UMLS CUI [1,3])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0279694 (UMLS CUI [2,3])
Comorbidity Severe Uncontrolled
Item
evidence of severe, uncontrolled concomitant disease
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Communicable Disease | Episode Major Communicable Disease | Requirement Antibiotics Intravenous | Hospitalization Required
Item
known active infection or any major episode of infection requiring treatment with iv antibiotics or hospitalization within 4 weeks before the start of cycle 1
boolean
C0009450 (UMLS CUI [1])
C0332189 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0009450 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C0003232 (UMLS CUI [3,2])
C1522726 (UMLS CUI [3,3])
C1708385 (UMLS CUI [4])
HIV Seropositivity
Item
seropositive for human immunodeficiency virus (hiv)
boolean
C0019699 (UMLS CUI [1])
Chronic Hepatitis B Positive | Serology positive Hepatitis B Surface Antigens
Item
positive for chronic hepatitis b infection (defined as positive hbsag serology)
boolean
C0524909 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0242089 (UMLS CUI [2,1])
C0019168 (UMLS CUI [2,2])
Hepatitis C positive | Hepatitis C Antibodies Serologic tests
Item
positive for hepatitis c (hepatitis c virus [hcv] antibody serology testing)
boolean
C1112419 (UMLS CUI [1])
C0166049 (UMLS CUI [2,1])
C0036743 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Systemic Corticosteroid Therapy | Exception Steroid therapy Low dose
Item
concurrent (or within 7 days prior to fist dose of study treatment) systemic corticosteroid use, except for low-dose corticosteroid therapy used to treat illness other than lymphoma
boolean
C4053960 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0149783 (UMLS CUI [2,2])
C0445550 (UMLS CUI [2,3])
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