ID

21544

Descrição

Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Rituximab Pateinets With Aggresive NHL; ODM derived from: https://clinicaltrials.gov/show/NCT01527422

Link

https://clinicaltrials.gov/show/NCT01527422

Palavras-chave

Versões (1)
  1. 26/04/2017 26/04/2017 -
Transferido a

26 de abril de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Lymphoma NCT01527422

Inglês

Eligibility Lymphoma NCT01527422

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01527422
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with previously untreated aggressive non-hodgkin's lymphoma. aggressive histologies include follicular large cell, diffuse large cell, peripheral t cell, transformed lymphomas, lymphoblastic lymphomas, burkitt and burkitt like lymphomas.
Descrição

Aggressive Non-Hodgkin Lymphoma untreated | Lymphoma, Large-Cell, Follicular | adult diffuse large cell lymphoma | Peripheral T-Cell Lymphoma | Lymphoma Transformed | Lymphoblastic lymphoma | Burkitt Lymphoma | Burkitt-like lymphoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1332225
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0079745
UMLS CUI [3]
C0278762
UMLS CUI [4]
C0079774
UMLS CUI [5,1]
C0024299
UMLS CUI [5,2]
C0457344
UMLS CUI [6]
C0079748
UMLS CUI [7]
C0006413
UMLS CUI [8]
C1368771
must have measurable or evaluable disease.
Descrição

Measurable Disease | Evaluable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
stage i-iv patients are eligible
Descrição

Ann Arbor lymphoma staging system

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0432516
patients must be 18 years or older.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
no evidence of grade 3 or more neurosensory or neuromotor dysfunction (see appendix-
Descrição

Neurosensory impairment CTCAE Grades | Neuromuscular Dysfunction CTCAE Grades

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4062958
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0597054
UMLS CUI [2,2]
C3887504
UMLS CUI [2,3]
C1516728
toxicity criteria)
Descrição

Toxicity criteria

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0243161
written consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
hiv positive patients and those with hepatitis b or c will be excluded from this protocol.
Descrição

HIV Seropositivity | Hepatitis B | Hepatitis C

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
patients with inadequate bone marrow and organ function as defined below:
Descrição

Bone Marrow function Inadequate | Organ function Inadequate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0205412
UMLS CUI [2,1]
C0678852
UMLS CUI [2,2]
C0205412
neutrophils <1,000/l
Descrição

Absolute neutrophil count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948762
platelets <100,000/l
Descrição

Platelet Count measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032181
billirubin >2
Descrição

Serum total bilirubin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
creatinine >2.0 or estimated crcl <30 cc/min
Descrição

Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C2711451
cns involvement by lymphoma.
Descrição

Central nervous system lymphoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0742472
uncontrolled intercurrent disease including arrhythmias, angina pectoris, class iii-iv congestive heart failure (chf symptoms on less than ordinary exertion or at rest) or active infection.
Descrição

Comorbidity Uncontrolled | Cardiac Arrhythmia | Angina Pectoris | Congestive heart failure New York Heart Association Classification | Symptomatic congestive heart failure At rest | Communicable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0003811
UMLS CUI [3]
C0002962
UMLS CUI [4,1]
C0018802
UMLS CUI [4,2]
C1275491
UMLS CUI [5,1]
C0742758
UMLS CUI [5,2]
C0443144
UMLS CUI [6]
C0009450
active infection or fever > 38.2 degrees c unless due to lymphoma.
Descrição

Communicable Disease | Fever Degrees Celsius | Communicable Disease Due to Lymphoma | Fever Due to Lymphoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0015967
UMLS CUI [2,2]
C0439237
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0024299
UMLS CUI [4,1]
C0015967
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0024299
subject is not using adequate contraceptive precautions.
Descrição

Contraceptive methods Lacking

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0332268
pregnancy or breast feeding
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 NCT01527422

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01527422
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Aggressive Non-Hodgkin Lymphoma untreated | Lymphoma, Large-Cell, Follicular | adult diffuse large cell lymphoma | Peripheral T-Cell Lymphoma | Lymphoma Transformed | Lymphoblastic lymphoma | Burkitt Lymphoma | Burkitt-like lymphoma
Item
patients with previously untreated aggressive non-hodgkin's lymphoma. aggressive histologies include follicular large cell, diffuse large cell, peripheral t cell, transformed lymphomas, lymphoblastic lymphomas, burkitt and burkitt like lymphomas.
boolean
C1332225 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0079745 (UMLS CUI [2])
C0278762 (UMLS CUI [3])
C0079774 (UMLS CUI [4])
C0024299 (UMLS CUI [5,1])
C0457344 (UMLS CUI [5,2])
C0079748 (UMLS CUI [6])
C0006413 (UMLS CUI [7])
C1368771 (UMLS CUI [8])
Measurable Disease | Evaluable Disease
Item
must have measurable or evaluable disease.
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Ann Arbor lymphoma staging system
Item
stage i-iv patients are eligible
boolean
C0432516 (UMLS CUI [1])
Age
Item
patients must be 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Neurosensory impairment CTCAE Grades | Neuromuscular Dysfunction CTCAE Grades
Item
no evidence of grade 3 or more neurosensory or neuromotor dysfunction (see appendix-
boolean
C4062958 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0597054 (UMLS CUI [2,1])
C3887504 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
Toxicity criteria
Item
toxicity criteria)
boolean
C0600688 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Informed Consent
Item
written consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
HIV Seropositivity | Hepatitis B | Hepatitis C
Item
hiv positive patients and those with hepatitis b or c will be excluded from this protocol.
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Bone Marrow function Inadequate | Organ function Inadequate
Item
patients with inadequate bone marrow and organ function as defined below:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0678852 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
Absolute neutrophil count
Item
neutrophils <1,000/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets <100,000/l
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
billirubin >2
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
creatinine >2.0 or estimated crcl <30 cc/min
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Central nervous system lymphoma
Item
cns involvement by lymphoma.
boolean
C0742472 (UMLS CUI [1])
Comorbidity Uncontrolled | Cardiac Arrhythmia | Angina Pectoris | Congestive heart failure New York Heart Association Classification | Symptomatic congestive heart failure At rest | Communicable Disease
Item
uncontrolled intercurrent disease including arrhythmias, angina pectoris, class iii-iv congestive heart failure (chf symptoms on less than ordinary exertion or at rest) or active infection.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0003811 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C0018802 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0742758 (UMLS CUI [5,1])
C0443144 (UMLS CUI [5,2])
C0009450 (UMLS CUI [6])
Communicable Disease | Fever Degrees Celsius | Communicable Disease Due to Lymphoma | Fever Due to Lymphoma
Item
active infection or fever > 38.2 degrees c unless due to lymphoma.
boolean
C0009450 (UMLS CUI [1])
C0015967 (UMLS CUI [2,1])
C0439237 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0024299 (UMLS CUI [3,3])
C0015967 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0024299 (UMLS CUI [4,3])
Contraceptive methods Lacking
Item
subject is not using adequate contraceptive precautions.
boolean
C0700589 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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