ID

39317

Descrição

Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01476787

Link

https://clinicaltrials.gov/show/NCT01476787

Palavras-chave

Versões (1)
  1. 19/12/2019 19/12/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

19 de dezembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Follicular Lymphoma NCT01476787

Inglês

Eligibility Follicular Lymphoma NCT01476787

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed follicular lymphoma grade 1, 2 or 3a, stage ii-iv
Descrição

Follicular Lymphoma Grade | Follicular Lymphoma Ann Arbor lymphoma staging system

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0441800
UMLS CUI [2,1]
C0024301
UMLS CUI [2,2]
C0432516
have no prior systemic treatment for lymphoma
Descrição

Systemic therapy Absent Lymphoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0024299
symptomatic follicular lymphoma requiring treatment.
Descrição

Follicular Lymphoma Symptomatic Treatment required for

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0332121
age ≥18 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group performance status 0-2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
willing to follow pregnancy precautions
Descrição

Contraceptive methods Willing

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0600109
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinical evidence of transformed lymphoma or grade 3b follicular lymphoma.
Descrição

Lymphoma transformation | Follicular Lymphoma Grade

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0040682
UMLS CUI [2,1]
C0024301
UMLS CUI [2,2]
C0441800
major surgery (excluding lymph node biopsy) within 28 days prior to signing informed consent.
Descrição

Major surgery | Exception Biopsy of lymph node

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0193842
known seropositive for or active viral infection with hepatitis b virus (hbv), hepatitis c virus (hcv), human immunodeficiency virus (hiv)
Descrição

Serology positive Hepatitis B | Serology positive Hepatitis C | HIV Seropositivity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242089
UMLS CUI [1,2]
C0019163
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0019196
UMLS CUI [3]
C0019699
known sensitivity or allergy to murine products.
Descrição

Hypersensitivity Product Murine

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1254351
UMLS CUI [1,3]
C0026809
presence or history of central nervous system involvement by lymphoma
Descrição

Central Nervous System Involvement Lymphoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0024299
at high risk for a venous thromboembolic event (vte) and not willing to take vte prophylaxis
Descrição

High risk of Venous Thromboembolism | Prophylactic treatment Unwilling Venous Thromboembolism

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C1861172
UMLS CUI [2,1]
C0199176
UMLS CUI [2,2]
C0558080
UMLS CUI [2,3]
C1861172
any of the following laboratory abnormalities:
Descrição

LABORATORY ABNORMALITIES

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1853129
serum aspartate transaminase or alanine transaminase > 3x upper limit of normal (uln), except in patients with documented liver involvement by lymphoma
Descrição

Aspartate aminotransferase increased | Alanine aminotransferase increased | Exception Liver Involvement with Lymphoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0023884
UMLS CUI [3,3]
C1314939
UMLS CUI [3,4]
C0024299
total bilirubin > 2.0 mg/dl (34 µmol/l) except in cases of gilberts syndrome and documented liver or pancreatic involvement by lymphoma
Descrição

Serum total bilirubin measurement | Exception Gilbert Disease | Exception Liver Involvement with Lymphoma | Exception Pancreas Involvement with Lymphoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0017551
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0023884
UMLS CUI [3,3]
C1314939
UMLS CUI [3,4]
C0024299
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0030274
UMLS CUI [4,3]
C1314939
UMLS CUI [4,4]
C0024299
creatinine clearance of < 30 ml/min
Descrição

Creatinine clearance measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0373595
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Similar models

Eligibility Follicular Lymphoma NCT01476787

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Follicular Lymphoma Grade | Follicular Lymphoma Ann Arbor lymphoma staging system
Item
histologically confirmed follicular lymphoma grade 1, 2 or 3a, stage ii-iv
boolean
C0024301 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0024301 (UMLS CUI [2,1])
C0432516 (UMLS CUI [2,2])
Systemic therapy Absent Lymphoma
Item
have no prior systemic treatment for lymphoma
boolean
C1515119 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
Follicular Lymphoma Symptomatic Treatment required for
Item
symptomatic follicular lymphoma requiring treatment.
boolean
C0024301 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
Age
Item
age ≥18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Contraceptive methods Willing
Item
willing to follow pregnancy precautions
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Lymphoma transformation | Follicular Lymphoma Grade
Item
clinical evidence of transformed lymphoma or grade 3b follicular lymphoma.
boolean
C0024299 (UMLS CUI [1,1])
C0040682 (UMLS CUI [1,2])
C0024301 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
Major surgery | Exception Biopsy of lymph node
Item
major surgery (excluding lymph node biopsy) within 28 days prior to signing informed consent.
boolean
C0679637 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0193842 (UMLS CUI [2,2])
Serology positive Hepatitis B | Serology positive Hepatitis C | HIV Seropositivity
Item
known seropositive for or active viral infection with hepatitis b virus (hbv), hepatitis c virus (hcv), human immunodeficiency virus (hiv)
boolean
C0242089 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0242089 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0019699 (UMLS CUI [3])
Hypersensitivity Product Murine
Item
known sensitivity or allergy to murine products.
boolean
C0020517 (UMLS CUI [1,1])
C1254351 (UMLS CUI [1,2])
C0026809 (UMLS CUI [1,3])
Central Nervous System Involvement Lymphoma
Item
presence or history of central nervous system involvement by lymphoma
boolean
C4050309 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
High risk of Venous Thromboembolism | Prophylactic treatment Unwilling Venous Thromboembolism
Item
at high risk for a venous thromboembolic event (vte) and not willing to take vte prophylaxis
boolean
C0332167 (UMLS CUI [1,1])
C1861172 (UMLS CUI [1,2])
C0199176 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C1861172 (UMLS CUI [2,3])
LABORATORY ABNORMALITIES
Item
any of the following laboratory abnormalities:
boolean
C1853129 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Exception Liver Involvement with Lymphoma
Item
serum aspartate transaminase or alanine transaminase > 3x upper limit of normal (uln), except in patients with documented liver involvement by lymphoma
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0023884 (UMLS CUI [3,2])
C1314939 (UMLS CUI [3,3])
C0024299 (UMLS CUI [3,4])
Serum total bilirubin measurement | Exception Gilbert Disease | Exception Liver Involvement with Lymphoma | Exception Pancreas Involvement with Lymphoma
Item
total bilirubin > 2.0 mg/dl (34 µmol/l) except in cases of gilberts syndrome and documented liver or pancreatic involvement by lymphoma
boolean
C1278039 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0017551 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0023884 (UMLS CUI [3,2])
C1314939 (UMLS CUI [3,3])
C0024299 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0030274 (UMLS CUI [4,2])
C1314939 (UMLS CUI [4,3])
C0024299 (UMLS CUI [4,4])
Creatinine clearance measurement
Item
creatinine clearance of < 30 ml/min
boolean
C0373595 (UMLS CUI [1])
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