ID

31074

Descrição

A Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-cell or Follicular Non-Hodgkin's Lymphoma (RATE); ODM derived from: https://clinicaltrials.gov/show/NCT00719472

Link

https://clinicaltrials.gov/show/NCT00719472

Palavras-chave

Versões (1)
  1. 18/07/2018 18/07/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

18 de julho de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Non-Hodgkin's Lymphoma NCT00719472

Inglês

Eligibility Non-Hodgkin's Lymphoma NCT00719472

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
age ≥ 18 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patients with previously untreated diffuse large b-cell lymphoma (dlbcl) who are scheduled to receive rituximab 375 mg/m^2 plus chop (cyclophosphamide, hydroxydaunorubicin [also called doxorubicin or adriamycin], oncovin [vincristine], prednisone or prednisolone) chemotherapy, or previously untreated follicular non-hodgkin lymphoma (nhl) who are scheduled to receive rituximab 375 mg/m^2 plus cvp (cyclophosphamide, vincristine, prednisolone) chemotherapy
Descrição

Diffuse Large B-Cell Lymphoma untreated | Rituximab plus CHOP Scheduled | Doxorubicin | Adriamycin | Oncovin | Vincristine | Prednisone | Prednisolone | Follicular Lymphoma untreated | Rituximab plus CVP Scheduled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0393022
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C0163868
UMLS CUI [2,4]
C0205539
UMLS CUI [3]
C0013089
UMLS CUI [4]
C0085752
UMLS CUI [5]
C0591904
UMLS CUI [6]
C0042679
UMLS CUI [7]
C0032952
UMLS CUI [8]
C0032950
UMLS CUI [9,1]
C0024301
UMLS CUI [9,2]
C0332155
UMLS CUI [10,1]
C0393022
UMLS CUI [10,2]
C0332287
UMLS CUI [10,3]
C0056633
UMLS CUI [10,4]
C0205539
eastern cooperative oncology group (ecog) performance status 0-2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
* clinically significant cardiovascular disease (eg, uncontrolled hypertension, myocardial infarction, unstable angina), new york heart association (nyha) classification grade ii or greater congestive heart failure, a ventricular arrhythmia requiring medication within 1 year prior to day 1, or nyha grade ii or greater peripheral vascular disease on day 1 (first day of treatment)
Descrição

Cardiovascular Disease | Uncontrolled hypertension | Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Ventricular arrhythmia Requirement Pharmaceutical Preparations | Peripheral Vascular Disease New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C1275491
UMLS CUI [6,1]
C0085612
UMLS CUI [6,2]
C1514873
UMLS CUI [6,3]
C0013227
UMLS CUI [7,1]
C0085096
UMLS CUI [7,2]
C1275491
patients who meet any of the following criteria will be excluded from further study participation after cycle 1:
Descrição

Criteria Fulfill | Study Subject Participation Status Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0332196
circulating lymphocyte count > 5,000/μl before the cycle 2 rituximab infusion
Descrição

Circulating Lymphocyte Count

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0175630
UMLS CUI [1,2]
C0200635
development of a serious and/or grade 3 or 4 adverse event during cycle 1 judged by the investigator to be related to the rituximab infusion
Descrição

Adverse event Serious | Adverse event CTCAE Grades | Relationship Rituximab Infusion

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C1516728
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0393022
UMLS CUI [3,3]
C0574032
prior premedication with additional corticosteroids other than the prednisone included in the chemotherapy regimens
Descrição

Premedication Adrenal Cortex Hormones Additional | Exception Prednisone

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0033045
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C1524062
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0032952
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Similar models

Eligibility Non-Hodgkin's Lymphoma NCT00719472

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Diffuse Large B-Cell Lymphoma untreated | Rituximab plus CHOP Scheduled | Doxorubicin | Adriamycin | Oncovin | Vincristine | Prednisone | Prednisolone | Follicular Lymphoma untreated | Rituximab plus CVP Scheduled
Item
patients with previously untreated diffuse large b-cell lymphoma (dlbcl) who are scheduled to receive rituximab 375 mg/m^2 plus chop (cyclophosphamide, hydroxydaunorubicin [also called doxorubicin or adriamycin], oncovin [vincristine], prednisone or prednisolone) chemotherapy, or previously untreated follicular non-hodgkin lymphoma (nhl) who are scheduled to receive rituximab 375 mg/m^2 plus cvp (cyclophosphamide, vincristine, prednisolone) chemotherapy
boolean
C0079744 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0393022 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0163868 (UMLS CUI [2,3])
C0205539 (UMLS CUI [2,4])
C0013089 (UMLS CUI [3])
C0085752 (UMLS CUI [4])
C0591904 (UMLS CUI [5])
C0042679 (UMLS CUI [6])
C0032952 (UMLS CUI [7])
C0032950 (UMLS CUI [8])
C0024301 (UMLS CUI [9,1])
C0332155 (UMLS CUI [9,2])
C0393022 (UMLS CUI [10,1])
C0332287 (UMLS CUI [10,2])
C0056633 (UMLS CUI [10,3])
C0205539 (UMLS CUI [10,4])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cardiovascular Disease | Uncontrolled hypertension | Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Ventricular arrhythmia Requirement Pharmaceutical Preparations | Peripheral Vascular Disease New York Heart Association Classification
Item
* clinically significant cardiovascular disease (eg, uncontrolled hypertension, myocardial infarction, unstable angina), new york heart association (nyha) classification grade ii or greater congestive heart failure, a ventricular arrhythmia requiring medication within 1 year prior to day 1, or nyha grade ii or greater peripheral vascular disease on day 1 (first day of treatment)
boolean
C0007222 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0018802 (UMLS CUI [5,1])
C1275491 (UMLS CUI [5,2])
C0085612 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C0013227 (UMLS CUI [6,3])
C0085096 (UMLS CUI [7,1])
C1275491 (UMLS CUI [7,2])
Criteria Fulfill | Study Subject Participation Status Excluded
Item
patients who meet any of the following criteria will be excluded from further study participation after cycle 1:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Circulating Lymphocyte Count
Item
circulating lymphocyte count > 5,000/μl before the cycle 2 rituximab infusion
boolean
C0175630 (UMLS CUI [1,1])
C0200635 (UMLS CUI [1,2])
Adverse event Serious | Adverse event CTCAE Grades | Relationship Rituximab Infusion
Item
development of a serious and/or grade 3 or 4 adverse event during cycle 1 judged by the investigator to be related to the rituximab infusion
boolean
C0877248 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C0439849 (UMLS CUI [3,1])
C0393022 (UMLS CUI [3,2])
C0574032 (UMLS CUI [3,3])
Premedication Adrenal Cortex Hormones Additional | Exception Prednisone
Item
prior premedication with additional corticosteroids other than the prednisone included in the chemotherapy regimens
boolean
C0033045 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0032952 (UMLS CUI [2,2])
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