ID

30428

Beskrivning

Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00651443

Länk

https://clinicaltrials.gov/show/NCT00651443

Nyckelord

Versioner (2)
  1. 2018-06-04 2018-06-04 -
  2. 2018-06-04 2018-06-04 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

4 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Lymphoma, Non-Hodgkin's NCT00651443

Engelsk

Eligibility Lymphoma, Non-Hodgkin's NCT00651443

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent (signed and dated).
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
age equal or greater than 18 at the time of consent.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed follicular nhl according to the revised european american lymphoma (real)/ world health organization (who) classification (from initial diagnosis) grades 1,2, or 3a.
Beskrivning

Follicular Lymphoma WHO tumor classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C1301142
at least 2 malignant lymph nodes of similar size (>1 cm in minimal dimension) and location that are readily accessible for excisional biopsy at the time of study entry.
Beskrivning

Lymph nodes Malignant Size Quantity | Site of access Suitable Excision biopsy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0205282
UMLS CUI [1,3]
C0456389
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C0589360
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C0184921
consent to 1 pretreatment and 1 post-treatment excisional biopsy of accessible tumor.
Beskrivning

Consent Tumor Excision biopsy | Excision biopsy pre treatment Quantity | Excision biopsy post treatment Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1511481
UMLS CUI [1,2]
C0027651
UMLS CUI [1,3]
C0184921
UMLS CUI [2,1]
C0184921
UMLS CUI [2,2]
C2709094
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0184921
UMLS CUI [3,2]
C2709088
UMLS CUI [3,3]
C1265611
acceptable hematologic, hepatic, and renal function parameters.
Beskrivning

Hematologic function | Liver function | Renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
who performance status equal or less than 2.
Beskrivning

WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
subjects of reproductive potential must agree to follow accepted birth control methods.
Beskrivning

Females & males of reproductive potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of lymphoma in cns.
Beskrivning

Central nervous system lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0742472
previous systemic anticancer treatment for nhl (including but not limited to radiation, myeloablative, or investigational therapy).
Beskrivning

Cancer treatment Systemic NHL | Therapeutic radiology procedure | Myeloablative Chemotherapy | Therapy, Investigational

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0024305
UMLS CUI [2]
C1522449
UMLS CUI [3]
C1513784
UMLS CUI [4]
C0949266
concurrent treatment with systemic steroids within 14 days of day 1.
Beskrivning

Systemic steroids

Datatyp

boolean

Alias
UMLS CUI [1]
C2825233
evidence of transformed lymphoma.
Beskrivning

Lymphoma Transformed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0457344
presence of malignancies within 3 years of study day 1 (except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (dcis) of breast, or basal or squamous cell skin cancer).
Beskrivning

Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix Treated | Exception DCIS Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007124
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0553723
UMLS CUI [5,3]
C1522326
history of hiv infection or aids.
Beskrivning

HIV Infection | Acquired Immunodeficiency Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0001175
serious nonmalignant disease.
Beskrivning

Disease Serious | Exception Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0006826
pregnant.
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
inability to comply with study and follow-up procedures.
Beskrivning

Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug.
Beskrivning

Disease Contraindicated Investigational New Drugs | Dysfunction Metabolic Contraindicated Investigational New Drugs | Physical Examination Contraindicated Investigational New Drugs | Laboratory Results Contraindicated Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1444657
UMLS CUI [1,3]
C0013230
UMLS CUI [2,1]
C3887504
UMLS CUI [2,2]
C0311400
UMLS CUI [2,3]
C1444657
UMLS CUI [2,4]
C0013230
UMLS CUI [3,1]
C0031809
UMLS CUI [3,2]
C1444657
UMLS CUI [3,3]
C0013230
UMLS CUI [4,1]
C1254595
UMLS CUI [4,2]
C1444657
UMLS CUI [4,3]
C0013230
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Similar models

Eligibility Lymphoma, Non-Hodgkin's NCT00651443

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent (signed and dated).
boolean
C0021430 (UMLS CUI [1])
Age
Item
age equal or greater than 18 at the time of consent.
boolean
C0001779 (UMLS CUI [1])
Follicular Lymphoma WHO tumor classification
Item
histologically confirmed follicular nhl according to the revised european american lymphoma (real)/ world health organization (who) classification (from initial diagnosis) grades 1,2, or 3a.
boolean
C0024301 (UMLS CUI [1,1])
C1301142 (UMLS CUI [1,2])
Lymph nodes Malignant Size Quantity | Site of access Suitable Excision biopsy
Item
at least 2 malignant lymph nodes of similar size (>1 cm in minimal dimension) and location that are readily accessible for excisional biopsy at the time of study entry.
boolean
C0024204 (UMLS CUI [1,1])
C0205282 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0589360 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C0184921 (UMLS CUI [2,3])
Consent Tumor Excision biopsy | Excision biopsy pre treatment Quantity | Excision biopsy post treatment Quantity
Item
consent to 1 pretreatment and 1 post-treatment excisional biopsy of accessible tumor.
boolean
C1511481 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
C0184921 (UMLS CUI [1,3])
C0184921 (UMLS CUI [2,1])
C2709094 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0184921 (UMLS CUI [3,1])
C2709088 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Hematologic function | Liver function | Renal function
Item
acceptable hematologic, hepatic, and renal function parameters.
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
WHO performance status scale
Item
who performance status equal or less than 2.
boolean
C1298650 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods
Item
subjects of reproductive potential must agree to follow accepted birth control methods.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Central nervous system lymphoma
Item
presence of lymphoma in cns.
boolean
C0742472 (UMLS CUI [1])
Cancer treatment Systemic NHL | Therapeutic radiology procedure | Myeloablative Chemotherapy | Therapy, Investigational
Item
previous systemic anticancer treatment for nhl (including but not limited to radiation, myeloablative, or investigational therapy).
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0024305 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2])
C1513784 (UMLS CUI [3])
C0949266 (UMLS CUI [4])
Systemic steroids
Item
concurrent treatment with systemic steroids within 14 days of day 1.
boolean
C2825233 (UMLS CUI [1])
Lymphoma Transformed
Item
evidence of transformed lymphoma.
boolean
C0024299 (UMLS CUI [1,1])
C0457344 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix Treated | Exception DCIS Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
presence of malignancies within 3 years of study day 1 (except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (dcis) of breast, or basal or squamous cell skin cancer).
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007124 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0553723 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
HIV Infection | Acquired Immunodeficiency Syndrome
Item
history of hiv infection or aids.
boolean
C0019693 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
Disease Serious | Exception Malignant Neoplasms
Item
serious nonmalignant disease.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
Pregnancy
Item
pregnant.
boolean
C0032961 (UMLS CUI [1])
Protocol Compliance Unable
Item
inability to comply with study and follow-up procedures.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Disease Contraindicated Investigational New Drugs | Dysfunction Metabolic Contraindicated Investigational New Drugs | Physical Examination Contraindicated Investigational New Drugs | Laboratory Results Contraindicated Investigational New Drugs
Item
any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug.
boolean
C0012634 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C3887504 (UMLS CUI [2,1])
C0311400 (UMLS CUI [2,2])
C1444657 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C0031809 (UMLS CUI [3,1])
C1444657 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
C1254595 (UMLS CUI [4,1])
C1444657 (UMLS CUI [4,2])
C0013230 (UMLS CUI [4,3])
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