ID

29382

Beskrivning

Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00742144

Länk

https://clinicaltrials.gov/show/NCT00742144

Nyckelord

Versioner (1)
  1. 2018-03-21 2018-03-21 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

21 mars 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Follicular Lymphoma NCT00742144

Engelsk

Eligibility Follicular Lymphoma NCT00742144

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
histologically confirmed relapsed or refractory cd20 positive fl grade 1-3a and 1 or more clearly demarcated lesions with a largest diameter = 1.5 cm, or cd5, cd19, cd20 and cd23 positive relapse or refractory cll.
Beskrivning

Recurrent Follicular Lymphoma CD20 Positive Grade | Refractory Follicular Lymphoma CD20 Positive Grade | Sharply demarcated lesion Quantity Diameter Size | Recurrent Chronic Lymphoid Leukemia CD5 Positive | Chronic lymphocytic leukaemia refractory CD5 Positive | Recurrent Chronic Lymphoid Leukemia CD19 Positive | Chronic lymphocytic leukaemia refractory CD19 Positive | Recurrent Chronic Lymphoid Leukemia CD20 Positive | Chronic lymphocytic leukaemia refractory CD20 Positive | Recurrent Chronic Lymphoid Leukemia CD23 Positive | Chronic lymphocytic leukaemia refractory CD23 Positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1335701
UMLS CUI [1,2]
C0054946
UMLS CUI [1,3]
C1514241
UMLS CUI [1,4]
C0441800
UMLS CUI [2,1]
C1335723
UMLS CUI [2,2]
C0054946
UMLS CUI [2,3]
C1514241
UMLS CUI [2,4]
C0441800
UMLS CUI [3,1]
C2168704
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C1301886
UMLS CUI [3,4]
C0456389
UMLS CUI [4,1]
C0854802
UMLS CUI [4,2]
C0054964
UMLS CUI [4,3]
C1514241
UMLS CUI [5,1]
C0278791
UMLS CUI [5,2]
C0054964
UMLS CUI [5,3]
C1514241
UMLS CUI [6,1]
C0854802
UMLS CUI [6,2]
C0108748
UMLS CUI [6,3]
C1514241
UMLS CUI [7,1]
C0278791
UMLS CUI [7,2]
C0108748
UMLS CUI [7,3]
C1514241
UMLS CUI [8,1]
C0854802
UMLS CUI [8,2]
C0054946
UMLS CUI [8,3]
C1514241
UMLS CUI [9,1]
C0278791
UMLS CUI [9,2]
C0054946
UMLS CUI [9,3]
C1514241
UMLS CUI [10,1]
C0854802
UMLS CUI [10,2]
C0123242
UMLS CUI [10,3]
C1514241
UMLS CUI [11,1]
C0278791
UMLS CUI [11,2]
C0123242
UMLS CUI [11,3]
C1514241
subjects must have adequate blood, liver, and kidney function.
Beskrivning

Hematologic function | Liver function | Renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
subjects who passed the provided periods from the last anti-cancer treatments at screening
Beskrivning

Cancer treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0920425
ecog performance status of 0-2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy more than 24 weeks at screening
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
current and past malignancy other than fl and cll within 5 years prior to screening.
Beskrivning

Malignant Neoplasms | Exception Follicular Lymphoma | Exception CLL

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0024301
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0023434
known richter's transformation
Beskrivning

Richter's syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0349631
previous autologous stem cell transplantation within 24 weeks prior to screening
Beskrivning

Transplantation of autologous hematopoietic stem cell

Datatyp

boolean

Alias
UMLS CUI [1]
C1831743
previous allogeneic stem cell transplantation
Beskrivning

Allogeneic Stem Cell Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C2242529
known cns involvement
Beskrivning

Central Nervous System Involvement

Datatyp

boolean

Alias
UMLS CUI [1]
C4050309
history of significant cerebrovascular disease
Beskrivning

Cerebrovascular Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0007820
current cardiac disease requiring medical treatment
Beskrivning

Heart Disease Treatment required for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0332121
chronic or ongoing active infectious disease requiring systemic treatment
Beskrivning

Chronic infectious disease Requirement Systemic therapy | Communicable Disease Requirement Systemic therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0151317
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C1515119
patients with pleural effusion or ascites detectable by physical examination
Beskrivning

Pleural effusion Physical Examination | Ascites Physical Examination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032227
UMLS CUI [1,2]
C0031809
UMLS CUI [2,1]
C0003962
UMLS CUI [2,2]
C0031809
positive serology test for any of hbsag, anti-hbc or anti-hcv
Beskrivning

Serology positive Hepatitis B Surface Antigens | Serology positive Anti-HBc | Serology positive Anti-HCV

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242089
UMLS CUI [1,2]
C0019168
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0312631
UMLS CUI [3,1]
C0242089
UMLS CUI [3,2]
C0166049
known hiv positive
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
pregnant or lactating women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing potential and male patients not willing to use adequate contraception
Beskrivning

Childbearing Potential Contraceptive methods Unwilling | Gender Contraceptive methods Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
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Similar models

Eligibility Follicular Lymphoma NCT00742144

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Recurrent Follicular Lymphoma CD20 Positive Grade | Refractory Follicular Lymphoma CD20 Positive Grade | Sharply demarcated lesion Quantity Diameter Size | Recurrent Chronic Lymphoid Leukemia CD5 Positive | Chronic lymphocytic leukaemia refractory CD5 Positive | Recurrent Chronic Lymphoid Leukemia CD19 Positive | Chronic lymphocytic leukaemia refractory CD19 Positive | Recurrent Chronic Lymphoid Leukemia CD20 Positive | Chronic lymphocytic leukaemia refractory CD20 Positive | Recurrent Chronic Lymphoid Leukemia CD23 Positive | Chronic lymphocytic leukaemia refractory CD23 Positive
Item
histologically confirmed relapsed or refractory cd20 positive fl grade 1-3a and 1 or more clearly demarcated lesions with a largest diameter = 1.5 cm, or cd5, cd19, cd20 and cd23 positive relapse or refractory cll.
boolean
C1335701 (UMLS CUI [1,1])
C0054946 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
C1335723 (UMLS CUI [2,1])
C0054946 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0441800 (UMLS CUI [2,4])
C2168704 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1301886 (UMLS CUI [3,3])
C0456389 (UMLS CUI [3,4])
C0854802 (UMLS CUI [4,1])
C0054964 (UMLS CUI [4,2])
C1514241 (UMLS CUI [4,3])
C0278791 (UMLS CUI [5,1])
C0054964 (UMLS CUI [5,2])
C1514241 (UMLS CUI [5,3])
C0854802 (UMLS CUI [6,1])
C0108748 (UMLS CUI [6,2])
C1514241 (UMLS CUI [6,3])
C0278791 (UMLS CUI [7,1])
C0108748 (UMLS CUI [7,2])
C1514241 (UMLS CUI [7,3])
C0854802 (UMLS CUI [8,1])
C0054946 (UMLS CUI [8,2])
C1514241 (UMLS CUI [8,3])
C0278791 (UMLS CUI [9,1])
C0054946 (UMLS CUI [9,2])
C1514241 (UMLS CUI [9,3])
C0854802 (UMLS CUI [10,1])
C0123242 (UMLS CUI [10,2])
C1514241 (UMLS CUI [10,3])
C0278791 (UMLS CUI [11,1])
C0123242 (UMLS CUI [11,2])
C1514241 (UMLS CUI [11,3])
Hematologic function | Liver function | Renal function
Item
subjects must have adequate blood, liver, and kidney function.
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Cancer treatment
Item
subjects who passed the provided periods from the last anti-cancer treatments at screening
boolean
C0920425 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy more than 24 weeks at screening
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Exception Follicular Lymphoma | Exception CLL
Item
current and past malignancy other than fl and cll within 5 years prior to screening.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0024301 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0023434 (UMLS CUI [3,2])
Richter's syndrome
Item
known richter's transformation
boolean
C0349631 (UMLS CUI [1])
Transplantation of autologous hematopoietic stem cell
Item
previous autologous stem cell transplantation within 24 weeks prior to screening
boolean
C1831743 (UMLS CUI [1])
Allogeneic Stem Cell Transplantation
Item
previous allogeneic stem cell transplantation
boolean
C2242529 (UMLS CUI [1])
Central Nervous System Involvement
Item
known cns involvement
boolean
C4050309 (UMLS CUI [1])
Cerebrovascular Disorders
Item
history of significant cerebrovascular disease
boolean
C0007820 (UMLS CUI [1])
Heart Disease Treatment required for
Item
current cardiac disease requiring medical treatment
boolean
C0018799 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Chronic infectious disease Requirement Systemic therapy | Communicable Disease Requirement Systemic therapy
Item
chronic or ongoing active infectious disease requiring systemic treatment
boolean
C0151317 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1515119 (UMLS CUI [2,3])
Pleural effusion Physical Examination | Ascites Physical Examination
Item
patients with pleural effusion or ascites detectable by physical examination
boolean
C0032227 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
Serology positive Hepatitis B Surface Antigens | Serology positive Anti-HBc | Serology positive Anti-HCV
Item
positive serology test for any of hbsag, anti-hbc or anti-hcv
boolean
C0242089 (UMLS CUI [1,1])
C0019168 (UMLS CUI [1,2])
C0242089 (UMLS CUI [2,1])
C0312631 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0166049 (UMLS CUI [3,2])
HIV Seropositivity
Item
known hiv positive
boolean
C0019699 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Unwilling | Gender Contraceptive methods Unwilling
Item
women of childbearing potential and male patients not willing to use adequate contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
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