ID

40706

Description

GP2013 in Japanese Patients With CD20 Positive Low Tumor Burden Indolent B-cell Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01933516

Link

https://clinicaltrials.gov/show/NCT01933516

Keywords

Versions (3)
  1. 1/16/19 1/16/19 -
  2. 4/26/20 4/26/20 -
  3. 5/1/20 5/1/20 -
Copyright Holder

Sandoz

Uploaded on

May 1, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Eligibility Indolent B-cell Non-Hodgkin's Lymphoma NCT01933516

English

Eligibility Indolent B-cell Non-Hodgkin's Lymphoma NCT01933516

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient with cd20 positive low tumor burden indolent b-cell non- hodgkin's lymphoma.
Description

Indolent B-Cell NHL, CD20+, low tumor burden

Data type

boolean

Alias
UMLS CUI [1,1]
C1334170
UMLS CUI [1,2]
C0079731
UMLS CUI [1,3]
C3888518
UMLS CUI [1,4]
C1449699
UMLS CUI [1,5]
C0205251
patient with at least one measurable lesion.
Description

Measurable disease Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
patient with ecog performance status 0 or 1.
Description

ECOG performace status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient who has received radiotherapy within the last 28 days prior to administration, or are not recovered from previous radiotherapy.
Description

Recent radiotherapy | prior radiotherapy recovery lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C2004454
UMLS CUI [2,3]
C0332268
patient who has received immunotherapy, chemotherapy, antibodies and experimental treatment within the last 28 days prior to administration, or are not recovered from previous therapy.
Description

Recent immunotherapy, chemotherapy, antibodies, experimental treatment | prior therapy recovery lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C3542957
UMLS CUI [3,2]
C0332185
UMLS CUI [4,1]
C0304229
UMLS CUI [4,2]
C0332185
UMLS CUI [5,1]
C1514463
UMLS CUI [5,2]
C2004454
UMLS CUI [5,3]
C0332268
patient who has mab therapy other than rituximab as prior line of therapy.
Description

Prior therapy with monoclonal antibodies | except for rituximab

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0003250
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0393022
patient with evidence of any uncontrolled, acute or chronic active infection (viral, bacterial or fungal).
Description

Uncontrolled infectious disease | viral, bacterial or fungal infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0042769
UMLS CUI [3]
C0004623
UMLS CUI [4]
C0026946
patient with any other malignancy within 5 years prior to date of screening, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or nonmelanomatous skin cancer.
Description

Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
other protocol-defined inclusion/exclusion criteria may apply.
Description

Clinical Trial Eligibility Criteria; Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Indolent B-cell Non-Hodgkin's Lymphoma NCT01933516

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Indolent B-Cell NHL, CD20+, low tumor burden
Item
patient with cd20 positive low tumor burden indolent b-cell non- hodgkin's lymphoma.
boolean
C1334170 (UMLS CUI [1,1])
C0079731 (UMLS CUI [1,2])
C3888518 (UMLS CUI [1,3])
C1449699 (UMLS CUI [1,4])
C0205251 (UMLS CUI [1,5])
Measurable disease Quantity
Item
patient with at least one measurable lesion.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
ECOG performace status
Item
patient with ecog performance status 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Recent radiotherapy | prior radiotherapy recovery lacking
Item
patient who has received radiotherapy within the last 28 days prior to administration, or are not recovered from previous radiotherapy.
boolean
C1522449 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C2004454 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Recent immunotherapy, chemotherapy, antibodies, experimental treatment | prior therapy recovery lacking
Item
patient who has received immunotherapy, chemotherapy, antibodies and experimental treatment within the last 28 days prior to administration, or are not recovered from previous therapy.
boolean
C0021083 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C3542957 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C0304229 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
C1514463 (UMLS CUI [5,1])
C2004454 (UMLS CUI [5,2])
C0332268 (UMLS CUI [5,3])
Prior therapy with monoclonal antibodies | except for rituximab
Item
patient who has mab therapy other than rituximab as prior line of therapy.
boolean
C1514463 (UMLS CUI [1,1])
C0003250 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0393022 (UMLS CUI [2,2])
Uncontrolled infectious disease | viral, bacterial or fungal infection
Item
patient with evidence of any uncontrolled, acute or chronic active infection (viral, bacterial or fungal).
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2])
C0004623 (UMLS CUI [3])
C0026946 (UMLS CUI [4])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
patient with any other malignancy within 5 years prior to date of screening, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or nonmelanomatous skin cancer.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Clinical Trial Eligibility Criteria; Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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