ID

41230

Descrição

A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01649856

Link

https://clinicaltrials.gov/show/NCT01649856

Palavras-chave

Versões (1)
  1. 21-07-20 21-07-20 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

21 juli 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Lymphoma, B-Cell NCT01649856

Inglês

Eligibility Lymphoma, B-Cell NCT01649856

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/= 18 and </= 80 years of age at time of study inclusion
Descrição

Adult | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
histologically confirmed, previously untreated cd20-positive diffuse large b-cell lymphoma (dlbcl) according to the who classification system
Descrição

Diffuse Large B-Cell Lymphoma CD20 positive Untreated WHO tumor classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C3888518
UMLS CUI [1,3]
C0332155
UMLS CUI [1,4]
C1301142
patients with an international prognostic index (ipi) score 1-5, or ipi score 0 with bulky disease, defined as one lesion >/= 7.5 cm
Descrição

International Prognostic Index | Bulky Disease | Lesion Size Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1512894
UMLS CUI [2]
C1511341
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0449453
UMLS CUI [3,3]
C1265611
at least one bi-dimensionally measurable lesion defined as >/= 1.5 cm in its largest dimension on ct scan, pet-ct scan or mri
Descrição

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

Tipo de dados

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
UMLS CUI [3,1]
C1275593
UMLS CUI [3,2]
C0032743
UMLS CUI [4,1]
C1275593
UMLS CUI [4,2]
C0024485
adequate hematologic function
Descrição

Hematologic function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0221130
eastern cooperative oncology group (eocd) performance status </= 2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
primary or secondary central nervous system lymphoma, histologic evidence of transformation to burkitt lymphoma, primary mediastinal dlbcl, primary effusion lymphoma, primary cutaneous dlbcl, or primary dlbcl of the testis
Descrição

Primary central nervous system lymphoma | Secondary Central Nervous System Lymphoma | Ttransformation Burkitt Lymphoma | Mediastinal (Thymic) Large B-Cell Lymphoma | Primary Effusion Lymphoma | Primary cutaneous diffuse large cell B-cell lymphoma | Large B-cell diffuse lymphoma of testis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0280803
UMLS CUI [2]
C2981383
UMLS CUI [3,1]
C0040682
UMLS CUI [3,2]
C0006413
UMLS CUI [4]
C1292754
UMLS CUI [5]
C1292753
UMLS CUI [6]
C1275325
UMLS CUI [7]
C2057634
transformed lymphoma or follicular lymphoma iiib
Descrição

Transformation Lymphoma | Follicular Lymphoma Ann Arbor lymphoma staging system

Tipo de dados

boolean

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

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

Tipo de dados

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
history of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin, carcinoma in situ of the cervix, or a malignancy that has been treated without curative intent and has been in remission without treatment for >/= 5 years prior to enrolment
Descrição

Cancer Other | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma | Exception Curative treatment Cutaneous Melanoma | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Malignant Neoplasm Remission Duration

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0007137
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0151779
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C0851140
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0006826
UMLS CUI [6,3]
C0687702
UMLS CUI [6,4]
C0449238
inadequate renal or hepatic function
Descrição

Renal function Inadequate | Liver function Inadequate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0205412
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C0205412
known human immunodeficiency virus (hiv) infection or hiv seropositive status
Descrição

HIV Infections | HIV Seropositivity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019699
active hepatitis b virus (hbv) or active hepatitis c virus (hcv) infection. patients with occult or prior hbv infection as defined by protocol may be included. patients positive for hcv antibody are eligible only if polymerase chain reaction testing for hcv ribonucleic acid is negative.
Descrição

Hepatitis B | Hepatitis C

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
Descrição

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 dados

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
Descrição

Medical contraindication Component CHOP regimen | Medical contraindication Anthracyclines

Tipo de dados

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
prior treatment with cytotoxic drugs or rituximab for another condition (e.g. rheumatoid arthritis) or prior use of an anti-cd20 antibody
Descrição

Cytotoxic agent | rituximab | Anti-CD20 Antibody

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0304497
UMLS CUI [2]
C0393022
UMLS CUI [3]
C3891557
pregnant or lactating women
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Lymphoma, B-Cell NCT01649856

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/= 18 and </= 80 years of age at time of study inclusion
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Diffuse Large B-Cell Lymphoma CD20 positive Untreated WHO tumor classification
Item
histologically confirmed, previously untreated cd20-positive diffuse large b-cell lymphoma (dlbcl) according to the who classification system
boolean
C0079744 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C1301142 (UMLS CUI [1,4])
International Prognostic Index | Bulky Disease | Lesion Size Quantity
Item
patients with an international prognostic index (ipi) score 1-5, or ipi score 0 with bulky disease, defined as one lesion >/= 7.5 cm
boolean
C1512894 (UMLS CUI [1])
C1511341 (UMLS CUI [2])
C0221198 (UMLS CUI [3,1])
C0449453 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Measurable Disease 2-Dimensional Quantity | Lesion size, largest dimension CT | Lesion size, largest dimension PET scan | Lesion size, largest dimension MRI
Item
at least one bi-dimensionally measurable lesion defined as >/= 1.5 cm in its largest dimension on ct scan, pet-ct scan or mri
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])
C1275593 (UMLS CUI [3,1])
C0032743 (UMLS CUI [3,2])
C1275593 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
Hematologic function
Item
adequate hematologic function
boolean
C0221130 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (eocd) performance status </= 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Primary central nervous system lymphoma | Secondary Central Nervous System Lymphoma | Ttransformation Burkitt Lymphoma | Mediastinal (Thymic) Large B-Cell Lymphoma | Primary Effusion Lymphoma | Primary cutaneous diffuse large cell B-cell lymphoma | Large B-cell diffuse lymphoma of testis
Item
primary or secondary central nervous system lymphoma, histologic evidence of transformation to burkitt lymphoma, primary mediastinal dlbcl, primary effusion lymphoma, primary cutaneous dlbcl, or primary dlbcl of the testis
boolean
C0280803 (UMLS CUI [1])
C2981383 (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])
C2057634 (UMLS CUI [7])
Transformation Lymphoma | Follicular Lymphoma Ann Arbor lymphoma staging system
Item
transformed lymphoma or follicular lymphoma iiib
boolean
C0040682 (UMLS CUI [1,1])
C0024299 (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])
Cancer Other | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma | Exception Curative treatment Cutaneous Melanoma | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Malignant Neoplasm Remission Duration
Item
history of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin, carcinoma in situ of the cervix, or a malignancy that has been treated without curative intent and has been in remission without treatment for >/= 5 years prior to enrolment
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0007137 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0151779 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C0851140 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0006826 (UMLS CUI [6,2])
C0687702 (UMLS CUI [6,3])
C0449238 (UMLS CUI [6,4])
Renal function Inadequate | Liver function Inadequate
Item
inadequate renal or hepatic function
boolean
C0232804 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
HIV Infections | HIV Seropositivity
Item
known human immunodeficiency virus (hiv) infection or hiv seropositive status
boolean
C0019693 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
Hepatitis B | Hepatitis C
Item
active hepatitis b virus (hbv) or active hepatitis c virus (hcv) infection. patients with occult or prior hbv infection as defined by protocol may be included. patients positive for hcv antibody are eligible only if polymerase chain reaction testing for hcv ribonucleic acid is negative.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
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])
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])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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