ID

41220

Descripción

A Study of Obinutuzumab (RO5072759) in Combination With CHOP Chemotherapy Versus MabThera/Rituxan (Rituximab) With CHOP in Patients With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA); ODM derived from: https://clinicaltrials.gov/show/NCT01287741

Link

https://clinicaltrials.gov/show/NCT01287741

Palabras clave

Versiones (1)
  1. 20/7/20 20/7/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

20 de julio de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lymphoma, B-Cell NCT01287741

Inglés

Eligibility Lymphoma, B-Cell NCT01287741

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/= 18 years of age
Descripción

Adult | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
previously untreated cd20-positive diffuse large b-cell lymphoma (dlbcl)
Descripción

Diffuse Large B-Cell Lymphoma CD20 positive Untreated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C3888518
UMLS CUI [1,3]
C0332155
at least 1 bi-dimensionally measurable lesion (>1.5 cm in is largest dimension on the ct scan)
Descripción

Measurable Disease 2-Dimensional Quantity | Lesion size, largest dimension CT scan

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1275593
UMLS CUI [2,2]
C0040405
eastern cooperative oncology group (ecog) performance status 0, 1 or 2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematological function
Descripción

Hematologic function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0221130
low-intermediate, intermediate or high-risk ipi score (low-risk ipi score: ipi 1 irrespective of bulky disease or ipi 0 with bulky disease, defined as one lesion >/= 7.5 cm)
Descripción

International Prognostic Index Low-Intermediate Risk Group | Risk Intermediate International Prognostic Index | High risk International Prognostic Index | Bulky Disease | Lesion size Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C5206109
UMLS CUI [2,1]
C0035647
UMLS CUI [2,2]
C0205103
UMLS CUI [2,3]
C1512894
UMLS CUI [3,1]
C4319571
UMLS CUI [3,2]
C1512894
UMLS CUI [4]
C1511341
UMLS CUI [5,1]
C0449453
UMLS CUI [5,2]
C1265611
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
Descripción

Allergic Reaction Severe Humanized Monoclonal Antibodies | Anaphylaxis Severe Humanized Monoclonal Antibodies | Allergic Reaction Severe Monoclonal Antibodies Murine | Anaphylaxis Severe Monoclonal Antibodies Murine | Hypersensitivity Product Murine

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2985546
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C2985546
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0003250
UMLS CUI [3,4]
C0026809
UMLS CUI [4,1]
C0002792
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0003250
UMLS CUI [4,4]
C0026809
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C1254351
UMLS CUI [5,3]
C0026809
contraindication to any of the individual components of chop, including prior receipt of anthracyclines
Descripción

Medical contraindication Component CHOP regimen | Medical contraindication Anthracyclines

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C0163868
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0282564
patients with transformed lymphoma and patients with follicular lymphoma iiib
Descripción

Lymphoma Transformation | Follicular Lymphoma Ann Arbor lymphoma staging system

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0040682
UMLS CUI [2,1]
C0024301
UMLS CUI [2,2]
C0432516
prior therapy for dlbcl, with the exception of nodal biopsy or local irradiation
Descripción

Prior Therapy Diffuse Large B-Cell Lymphoma | Exception Biopsy of lymph node | Exception Therapeutic radiology procedure Local

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0079744
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0193842
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1522449
UMLS CUI [3,3]
C0205276
prior treatment with cytotoxic drugs or rituximab for another condition (e.g., rheumatoid arthritis) or prior use of an anti-cd20 antibody
Descripción

Cytotoxic agent | rituximab | Anti-CD20 Antibody

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0304497
UMLS CUI [2]
C0393022
UMLS CUI [3]
C3891557
prior use of any monoclonal antibody within 3 months of the start of cycle 1
Descripción

Monoclonal Antibodies

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003250
ongoing corticosteroid use of > 30 mg/day of prednisone or equivalent
Descripción

Steroid therapy | Prednisone U/day | Equivalent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0149783
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0456683
UMLS CUI [3]
C0205163
primary cns lymphoma, blastic variant of mantle-cell lymphoma, or histologic evidence of transformation to a burkitt lymphoma, primary mediastinal dlbcl, primary effusion lymphoma, and primary cutaneous dlbcl
Descripción

Primary central nervous system lymphoma | Mantle-cell lymphoma | Transformation Burkitt Lymphoma | Mediastinal (Thymic) Large B-Cell Lymphoma | Primary Effusion Lymphoma | Primary cutaneous diffuse large cell B-cell lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0280803
UMLS CUI [2]
C0334634
UMLS CUI [3,1]
C0040682
UMLS CUI [3,2]
C0006413
UMLS CUI [4]
C1292754
UMLS CUI [5]
C1292753
UMLS CUI [6]
C1275325
positive for hiv
Descripción

HIV Seropositivity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
active hepatitis b or c infection
Descripción

Hepatitis B | Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
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Similar models

Eligibility Lymphoma, B-Cell NCT01287741

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Diffuse Large B-Cell Lymphoma CD20 positive Untreated
Item
previously untreated cd20-positive diffuse large b-cell lymphoma (dlbcl)
boolean
C0079744 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
Measurable Disease 2-Dimensional Quantity | Lesion size, largest dimension CT scan
Item
at least 1 bi-dimensionally measurable lesion (>1.5 cm in is largest dimension on the ct scan)
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1275593 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Hematologic function
Item
adequate hematological function
boolean
C0221130 (UMLS CUI [1])
International Prognostic Index Low-Intermediate Risk Group | Risk Intermediate International Prognostic Index | High risk International Prognostic Index | Bulky Disease | Lesion size Quantity
Item
low-intermediate, intermediate or high-risk ipi score (low-risk ipi score: ipi 1 irrespective of bulky disease or ipi 0 with bulky disease, defined as one lesion >/= 7.5 cm)
boolean
C5206109 (UMLS CUI [1])
C0035647 (UMLS CUI [2,1])
C0205103 (UMLS CUI [2,2])
C1512894 (UMLS CUI [2,3])
C4319571 (UMLS CUI [3,1])
C1512894 (UMLS CUI [3,2])
C1511341 (UMLS CUI [4])
C0449453 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Allergic Reaction Severe Humanized Monoclonal Antibodies | Anaphylaxis Severe Humanized Monoclonal Antibodies | Allergic Reaction Severe Monoclonal Antibodies Murine | Anaphylaxis Severe Monoclonal Antibodies Murine | Hypersensitivity Product Murine
Item
history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
boolean
C1527304 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2985546 (UMLS CUI [1,3])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2985546 (UMLS CUI [2,3])
C1527304 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0003250 (UMLS CUI [3,3])
C0026809 (UMLS CUI [3,4])
C0002792 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0003250 (UMLS CUI [4,3])
C0026809 (UMLS CUI [4,4])
C0020517 (UMLS CUI [5,1])
C1254351 (UMLS CUI [5,2])
C0026809 (UMLS CUI [5,3])
Medical contraindication Component CHOP regimen | Medical contraindication Anthracyclines
Item
contraindication to any of the individual components of chop, including prior receipt of anthracyclines
boolean
C1301624 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0163868 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0282564 (UMLS CUI [2,2])
Lymphoma Transformation | Follicular Lymphoma Ann Arbor lymphoma staging system
Item
patients with transformed lymphoma and patients with follicular lymphoma iiib
boolean
C0024299 (UMLS CUI [1,1])
C0040682 (UMLS CUI [1,2])
C0024301 (UMLS CUI [2,1])
C0432516 (UMLS CUI [2,2])
Prior Therapy Diffuse Large B-Cell Lymphoma | Exception Biopsy of lymph node | Exception Therapeutic radiology procedure Local
Item
prior therapy for dlbcl, with the exception of nodal biopsy or local irradiation
boolean
C1514463 (UMLS CUI [1,1])
C0079744 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0193842 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C0205276 (UMLS CUI [3,3])
Cytotoxic agent | rituximab | Anti-CD20 Antibody
Item
prior treatment with cytotoxic drugs or rituximab for another condition (e.g., rheumatoid arthritis) or prior use of an anti-cd20 antibody
boolean
C0304497 (UMLS CUI [1])
C0393022 (UMLS CUI [2])
C3891557 (UMLS CUI [3])
Monoclonal Antibodies
Item
prior use of any monoclonal antibody within 3 months of the start of cycle 1
boolean
C0003250 (UMLS CUI [1])
Steroid therapy | Prednisone U/day | Equivalent
Item
ongoing corticosteroid use of > 30 mg/day of prednisone or equivalent
boolean
C0149783 (UMLS CUI [1])
C0032952 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0205163 (UMLS CUI [3])
Primary central nervous system lymphoma | Mantle-cell lymphoma | Transformation Burkitt Lymphoma | Mediastinal (Thymic) Large B-Cell Lymphoma | Primary Effusion Lymphoma | Primary cutaneous diffuse large cell B-cell lymphoma
Item
primary cns lymphoma, blastic variant of mantle-cell lymphoma, or histologic evidence of transformation to a burkitt lymphoma, primary mediastinal dlbcl, primary effusion lymphoma, and primary cutaneous dlbcl
boolean
C0280803 (UMLS CUI [1])
C0334634 (UMLS CUI [2])
C0040682 (UMLS CUI [3,1])
C0006413 (UMLS CUI [3,2])
C1292754 (UMLS CUI [4])
C1292753 (UMLS CUI [5])
C1275325 (UMLS CUI [6])
HIV Seropositivity
Item
positive for hiv
boolean
C0019699 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
active hepatitis b or c infection
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
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