ID

41239

Beschreibung

A Study of Patient Preference With Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Patients With CD20+ Diffuse Large B-Cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2 or 3a; ODM derived from: https://clinicaltrials.gov/show/NCT01724021

Link

https://clinicaltrials.gov/show/NCT01724021

Stichworte

Versionen (1)
  1. 22.07.20 22.07.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

22. Juli 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Lymphoma, B-Cell, Non-Hodgkin's Lymphoma NCT01724021

Englisch

Eligibility Lymphoma, B-Cell, Non-Hodgkin's Lymphoma NCT01724021

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/= 18 and </= 80 years of age
Beschreibung

Adult | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
histologically confirmed, previously untreated cd20+ diffuse large b-cell lymphoma (dlbcl) or cd20+ follicular non-hodgkin's lymphoma (nhl) grade 1, 2, or 3a, according to who classification
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C3888518
UMLS CUI [1,3]
C0332155
UMLS CUI [2,1]
C0024301
UMLS CUI [2,2]
C3888518
UMLS CUI [2,3]
C1301142
an international prognostic index (ipi) score of 1-4 or ipi score of 0 with bulky disease, defined as one lesion >/= 7.5 cm, or follicular lymphoma international prognostic index (flipi; low, intermediate or high risk)
Beschreibung

International Prognostic Index | Bulky Disease | Lesion Size Quantity | Follicular Lymphoma International Prognostic Index

Datentyp

boolean

Alias
UMLS CUI [1]
C1512894
UMLS CUI [2]
C1511341
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0456389
UMLS CUI [3,3]
C1265611
UMLS CUI [4]
C4040298
at least one bi-dimensionally measurable lesion defined as >/=1.5 cm in its largest dimension on ct scan
Beschreibung

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

Datentyp

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 </= 3
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
transformed lymphoma or follicular lymphoma iiib
Beschreibung

Transformation Lymphoma | Follicular Lymphoma Ann Arbor lymphoma staging system

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040682
UMLS CUI [1,2]
C0024299
UMLS CUI [2,1]
C0024301
UMLS CUI [2,2]
C0432516
primary central nervous system (cns) lymphoma, histologic evidence of transformation to burkitt lymphoma, primary mediastinal dlbcl, primary effusion lymphoma, primary cutaneous dlbcl, or primary dlbcl of the testis
Beschreibung

Primary central nervous system lymphoma | Transformation 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

Datentyp

boolean

Alias
UMLS CUI [1]
C0280803
UMLS CUI [2,1]
C0040682
UMLS CUI [2,2]
C0006413
UMLS CUI [3]
C1292754
UMLS CUI [4]
C1292753
UMLS CUI [5]
C1275325
UMLS CUI [6]
C2057634
history of other malignancy that could affect compliance with the protocol or interpretation of the results; this includes a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission for >/= 5 years prior to enrolment; patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are eligible
Beschreibung

Cancer Other Affecting Protocol Compliance | Cancer Other Affecting Interpretation Research results | Exception Cancer Remission Duration | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Curative treatment Cutaneous Melanoma | Exception Curative treatment Carcinoma in situ of uterine cervix

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C1707251
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0459471
UMLS CUI [2,4]
C0683954
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0687702
UMLS CUI [3,3]
C0449238
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0007117
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C0553723
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1273390
UMLS CUI [6,3]
C0151779
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1273390
UMLS CUI [7,3]
C0851140
prior therapy for dlbcl or nhl, with the exception of nodal biopsy or local irradiation
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0079744
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0024305
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0193842
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1522449
UMLS CUI [4,3]
C0205276
prior treatment with cytotoxic drugs (with the exclusion of intrathecal methotrexate for cns prophylaxis in dlbcl) or rituximab for another condition, or prior use of an anti-cd20 drug
Beschreibung

Cytotoxic agent | Exception Intrathecal Methotrexate Regimen Central Nervous System Prophylaxis | rituximab | Pharmaceutical Preparations Against CD20

Datentyp

boolean

Alias
UMLS CUI [1]
C0304497
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C5204906
UMLS CUI [2,3]
C1516386
UMLS CUI [3]
C0393022
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0521124
UMLS CUI [4,3]
C0054946
prior use of monoclonal antibody within 3 months prior to randomization
Beschreibung

Monoclonal Antibodies

Datentyp

boolean

Alias
UMLS CUI [1]
C0003250
chemotherapy or other investigational therapy within 28 days prior to randomization
Beschreibung

Chemotherapy | Therapies, Investigational

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0949266
ongoing corticosteroid use > 30 mg/day prednisolone or equivalent
Beschreibung

Adrenal Cortex Hormones | Prednisolone U/day | Equivalent

Datentyp

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C0032950
UMLS CUI [2,2]
C0456683
UMLS CUI [3]
C0205163
inadequate renal. hematologic or hepatic function
Beschreibung

Renal function Inadequate | Hematologic function Inadequate | Liver function Inadequate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0205412
UMLS CUI [2,1]
C0221130
UMLS CUI [2,2]
C0205412
UMLS CUI [3,1]
C0232741
UMLS CUI [3,2]
C0205412
active and/or severe infection or any major episode of infection within 4 weeks prior to randomization
Beschreibung

Communicable Disease | Communicable Disease Severe | Episode Major Communicable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0332189
UMLS CUI [3,2]
C0205164
UMLS CUI [3,3]
C0009450
active hepatitis b virus or active hepatitis c virus infection
Beschreibung

Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
history of human immunodeficiency (hiv) seropositive status
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
a positive pregnancy test in women of childbearing potential
Beschreibung

Pregnancy test positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0240802
life expectancy of less than 6 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
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Ähnliche Modelle

Eligibility Lymphoma, B-Cell, Non-Hodgkin's Lymphoma NCT01724021

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/= 18 and </= 80 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Diffuse Large B-Cell Lymphoma CD20 positive Untreated | Follicular Lymphoma CD20 positive WHO tumor classification
Item
histologically confirmed, previously untreated cd20+ diffuse large b-cell lymphoma (dlbcl) or cd20+ follicular non-hodgkin's lymphoma (nhl) grade 1, 2, or 3a, according to who classification
boolean
C0079744 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C0024301 (UMLS CUI [2,1])
C3888518 (UMLS CUI [2,2])
C1301142 (UMLS CUI [2,3])
International Prognostic Index | Bulky Disease | Lesion Size Quantity | Follicular Lymphoma International Prognostic Index
Item
an international prognostic index (ipi) score of 1-4 or ipi score of 0 with bulky disease, defined as one lesion >/= 7.5 cm, or follicular lymphoma international prognostic index (flipi; low, intermediate or high risk)
boolean
C1512894 (UMLS CUI [1])
C1511341 (UMLS CUI [2])
C0221198 (UMLS CUI [3,1])
C0456389 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C4040298 (UMLS CUI [4])
Measurable lesion 2-Dimensional Quantity | Lesion size, largest dimension CT
Item
at least one bi-dimensionally measurable lesion defined as >/=1.5 cm in its largest dimension on 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 </= 3
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
Primary central nervous system lymphoma | Transformation 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 central nervous system (cns) 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])
C0040682 (UMLS CUI [2,1])
C0006413 (UMLS CUI [2,2])
C1292754 (UMLS CUI [3])
C1292753 (UMLS CUI [4])
C1275325 (UMLS CUI [5])
C2057634 (UMLS CUI [6])
Cancer Other Affecting Protocol Compliance | Cancer Other Affecting Interpretation Research results | Exception Cancer Remission Duration | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Curative treatment Cutaneous Melanoma | Exception Curative treatment Carcinoma in situ of uterine cervix
Item
history of other malignancy that could affect compliance with the protocol or interpretation of the results; this includes a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission for >/= 5 years prior to enrolment; patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are eligible
boolean
C1707251 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C1707251 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0687702 (UMLS CUI [3,2])
C0449238 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0007117 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C0553723 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C1273390 (UMLS CUI [6,2])
C0151779 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C1273390 (UMLS CUI [7,2])
C0851140 (UMLS CUI [7,3])
Prior Therapy Diffuse Large B-Cell Lymphoma | Prior Therapy Non-Hodgkin Lymphoma | Exception Biopsy of lymph node | Exception Therapeutic radiology procedure Local
Item
prior therapy for dlbcl or nhl, with the exception of nodal biopsy or local irradiation
boolean
C1514463 (UMLS CUI [1,1])
C0079744 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0024305 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0193842 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1522449 (UMLS CUI [4,2])
C0205276 (UMLS CUI [4,3])
Cytotoxic agent | Exception Intrathecal Methotrexate Regimen Central Nervous System Prophylaxis | rituximab | Pharmaceutical Preparations Against CD20
Item
prior treatment with cytotoxic drugs (with the exclusion of intrathecal methotrexate for cns prophylaxis in dlbcl) or rituximab for another condition, or prior use of an anti-cd20 drug
boolean
C0304497 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C5204906 (UMLS CUI [2,2])
C1516386 (UMLS CUI [2,3])
C0393022 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0521124 (UMLS CUI [4,2])
C0054946 (UMLS CUI [4,3])
Monoclonal Antibodies
Item
prior use of monoclonal antibody within 3 months prior to randomization
boolean
C0003250 (UMLS CUI [1])
Chemotherapy | Therapies, Investigational
Item
chemotherapy or other investigational therapy within 28 days prior to randomization
boolean
C0392920 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Adrenal Cortex Hormones | Prednisolone U/day | Equivalent
Item
ongoing corticosteroid use > 30 mg/day prednisolone or equivalent
boolean
C0001617 (UMLS CUI [1])
C0032950 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0205163 (UMLS CUI [3])
Renal function Inadequate | Hematologic function Inadequate | Liver function Inadequate
Item
inadequate renal. hematologic or hepatic function
boolean
C0232804 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0221130 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0232741 (UMLS CUI [3,1])
C0205412 (UMLS CUI [3,2])
Communicable Disease | Communicable Disease Severe | Episode Major Communicable Disease
Item
active and/or severe infection or any major episode of infection within 4 weeks prior to randomization
boolean
C0009450 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332189 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0009450 (UMLS CUI [3,3])
Hepatitis B | Hepatitis C
Item
active hepatitis b virus or active hepatitis c virus infection
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
HIV Seropositivity
Item
history of human immunodeficiency (hiv) seropositive status
boolean
C0019699 (UMLS CUI [1])
Pregnancy test positive
Item
a positive pregnancy test in women of childbearing potential
boolean
C0240802 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of less than 6 months
boolean
C0023671 (UMLS CUI [1])
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