ID

31072

Description

A Study of PRO95780 in Combination With Rituximab in Patients With Non-Hodgkin's Lymphoma That Has Progressed Following Previous Rituximab Therapy (APM4083g); ODM derived from: https://clinicaltrials.gov/show/NCT00517049

Link

https://clinicaltrials.gov/show/NCT00517049

Keywords

Versions (1)
  1. 7/17/18 7/17/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 17, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Hodgkin's Lymphoma NCT00517049

English

Eligibility Non-Hodgkin's Lymphoma NCT00517049

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of follicular, cd20-positive b-cell nhl
Description

Follicular Lymphoma CD20 positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C3888518
progression of disease after an objective response or stable disease lasting > 6 months following completion of the most recent rituximab-containing regimen
Description

Disease Progression Post Response | Stable Disease Post Rituximab therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C1704632
UMLS CUI [2,1]
C0677946
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C4047978
measurable disease
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
life expectancy of > 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
grade 3b follicular lymphoma (according to the who classification) or histologic transformation from follicular lymphoma to aggressive lymphoma
Description

Follicular Lymphoma WHO tumor classification | Transformation Histologic Follicular Lymphoma Aggressive Lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C1301142
UMLS CUI [2,1]
C0040682
UMLS CUI [2,2]
C0205462
UMLS CUI [2,3]
C0024301
UMLS CUI [2,4]
C1332225
prior radiotherapy to a lesion(s) that will be used to assess response unless that lesion(s) shows clear evidence of lymphoma progression at baseline
Description

Prior radiation therapy Lesion | Disease Response Assessment | Exception Lymphoma progression

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0221198
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C1516048
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1737265
radiotherapy to a peripheral lesion within 14 days prior to cycle 1, day 1 or radiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior to cycle 1, day 1
Description

Therapeutic radiology procedure Lesion Peripheral | Radiotherapy to thorax | Radiotherapy to abdomen | Radiotherapy to pelvis

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0205100
UMLS CUI [2]
C4038705
UMLS CUI [3]
C1997554
UMLS CUI [4]
C1536155
concurrent systemic corticosteroid therapy
Description

Systemic Corticosteroid Therapy

Data type

boolean

Alias
UMLS CUI [1]
C4053960
other invasive malignancies within 3 years prior to first study drug administration except for adequately treated basal or squamous cell skin cancer, in situ carcinoma of the cervix, in situ breast cancer, in situ prostate cancer, limited-stage bladder cancer, or other cancers from which the patient has been disease-free for at least 3 years.
Description

Invasive cancer | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of female breast Treated | Exception Carcinoma in situ of prostate Treated | Exception Carcinoma of bladder TNM Staging System | Exception Disease Free of

Data type

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0686288
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0154088
UMLS CUI [6,3]
C1522326
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0699885
UMLS CUI [7,3]
C1515169
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0012634
UMLS CUI [8,3]
C0332296
history or evidence on physical examination of central nervous system (cns) disease
Description

CNS disorder Physical Examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0031809
prior treatment with agonistic dr4 or dr5 antibodies or apo2l/trail
Description

Prior Therapy | Anti-DR4 Agonist | Anti-DR5 Monoclonal Antibody | APO2L/TRAIL

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C4035465
UMLS CUI [2,2]
C2987634
UMLS CUI [3]
C2987421
UMLS CUI [4]
C0385242
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Similar models

Eligibility Non-Hodgkin's Lymphoma NCT00517049

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed informed consent form
boolean
C0021430 (UMLS CUI [1])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Follicular Lymphoma CD20 positive
Item
diagnosis of follicular, cd20-positive b-cell nhl
boolean
C0024301 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
Disease Progression Post Response | Stable Disease Post Rituximab therapy
Item
progression of disease after an objective response or stable disease lasting > 6 months following completion of the most recent rituximab-containing regimen
boolean
C0242656 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1704632 (UMLS CUI [1,3])
C0677946 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C4047978 (UMLS CUI [2,3])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of > 3 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Follicular Lymphoma WHO tumor classification | Transformation Histologic Follicular Lymphoma Aggressive Lymphoma
Item
grade 3b follicular lymphoma (according to the who classification) or histologic transformation from follicular lymphoma to aggressive lymphoma
boolean
C0024301 (UMLS CUI [1,1])
C1301142 (UMLS CUI [1,2])
C0040682 (UMLS CUI [2,1])
C0205462 (UMLS CUI [2,2])
C0024301 (UMLS CUI [2,3])
C1332225 (UMLS CUI [2,4])
Prior radiation therapy Lesion | Disease Response Assessment | Exception Lymphoma progression
Item
prior radiotherapy to a lesion(s) that will be used to assess response unless that lesion(s) shows clear evidence of lymphoma progression at baseline
boolean
C0279134 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1737265 (UMLS CUI [3,2])
Therapeutic radiology procedure Lesion Peripheral | Radiotherapy to thorax | Radiotherapy to abdomen | Radiotherapy to pelvis
Item
radiotherapy to a peripheral lesion within 14 days prior to cycle 1, day 1 or radiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior to cycle 1, day 1
boolean
C1522449 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205100 (UMLS CUI [1,3])
C4038705 (UMLS CUI [2])
C1997554 (UMLS CUI [3])
C1536155 (UMLS CUI [4])
Systemic Corticosteroid Therapy
Item
concurrent systemic corticosteroid therapy
boolean
C4053960 (UMLS CUI [1])
Invasive cancer | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of female breast Treated | Exception Carcinoma in situ of prostate Treated | Exception Carcinoma of bladder TNM Staging System | Exception Disease Free of
Item
other invasive malignancies within 3 years prior to first study drug administration except for adequately treated basal or squamous cell skin cancer, in situ carcinoma of the cervix, in situ breast cancer, in situ prostate cancer, limited-stage bladder cancer, or other cancers from which the patient has been disease-free for at least 3 years.
boolean
C0677898 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0686288 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0154088 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0699885 (UMLS CUI [7,2])
C1515169 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0012634 (UMLS CUI [8,2])
C0332296 (UMLS CUI [8,3])
CNS disorder Physical Examination
Item
history or evidence on physical examination of central nervous system (cns) disease
boolean
C0007682 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Prior Therapy | Anti-DR4 Agonist | Anti-DR5 Monoclonal Antibody | APO2L/TRAIL
Item
prior treatment with agonistic dr4 or dr5 antibodies or apo2l/trail
boolean
C1514463 (UMLS CUI [1])
C4035465 (UMLS CUI [2,1])
C2987634 (UMLS CUI [2,2])
C2987421 (UMLS CUI [3])
C0385242 (UMLS CUI [4])
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