ID

43821

Descrição

Bortezomib (VELCADE), Cladribine and Rituximab (VCR) in Mantle Cell Lymphoma (PSHCI 10-011); ODM derived from: https://clinicaltrials.gov/show/NCT01439750

Link

https://clinicaltrials.gov/show/NCT01439750

Palavras-chave

Versões (2)
  1. 13/03/2016 13/03/2016 -
  2. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Mantle Cell Lymphoma NCT01439750

Inglês

Eligibility Mantle Cell Lymphoma NCT01439750

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
females that are postmenopausal for at least 1 year before the screening visit, surgically sterilized or if they are of childbearing potential agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose.
Descrição

female postmenopausal; Contraception status; informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0086287
UMLS CUI [1,2]
C0232970
UMLS CUI [2]
C0086287
UMLS CUI [3]
C0021430
male subjects must agree to practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse.
Descrição

male; Contraception, Barrier; abstaining from sex

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0086582
UMLS CUI [2]
C0004764
UMLS CUI [3]
C1171321
patients with newly diagnosed and relapsed mantle cell lymphoma.
Descrição

Mantle cell lymphoma recurrent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0677725
ecog performance status grade 3 or higher.
Descrição

ecog

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has a platelet count of <50x10 9/l within 14 days before enrollment if not related to disease.
Descrição

platelet count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032181
patient has an absolute neutrophil count less than 100 within 14 days before enrollment if not related to disease.
Descrição

absolute neutrophil count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948762
patient has a calculated or measured creatinine clearance of <20 ml/minute within 14 days before enrollment.
Descrição

creatinine clearance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0373595
patient has > grade 2 peripheral neuropathy within 14 days before enrollment.
Descrição

peripheral neuropathy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0031117
patient has > 1.5 x uln total bilirubin.
Descrição

total bilirubin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201913
myocardial infarction within 6 months prior to enrollment or has new york heart association class ii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Descrição

myocardial infarction; New York Heart Association Classification; Angina Pectoris; ventricular arrhythmia; electrocardiography

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C1275491
UMLS CUI [3]
C0002962
UMLS CUI [4]
C0085612
UMLS CUI [5]
C1623258
patient has hypersensitivity to bortezomib, boron or mannitol.
Descrição

hypersensitivity bortezomib boron mannitol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1176309
UMLS CUI [1,3]
C0006030
UMLS CUI [1,4]
C0024730
female subject is pregnant or breast-feeding.
Descrição

pregnancy; lactating

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient has received other investigational drugs within 14 days before enrollment.
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Descrição

Compliance behavior Limited Comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
Descrição

malignancy; basal cell carcinoma; squamous cell carcinoma; prostate cancer

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0007137
UMLS CUI [4]
C0600139
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Similar models

Eligibility Mantle Cell Lymphoma NCT01439750

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
female postmenopausal; Contraception status; informed consent
Item
females that are postmenopausal for at least 1 year before the screening visit, surgically sterilized or if they are of childbearing potential agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose.
boolean
C0086287 (UMLS CUI [1,1])
C0232970 (UMLS CUI [1,2])
C0086287 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
male; Contraception, Barrier; abstaining from sex
Item
male subjects must agree to practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse.
boolean
C0086582 (UMLS CUI [1])
C0004764 (UMLS CUI [2])
C1171321 (UMLS CUI [3])
Mantle cell lymphoma recurrent
Item
patients with newly diagnosed and relapsed mantle cell lymphoma.
boolean
C0677725 (UMLS CUI [1])
ecog
Item
ecog performance status grade 3 or higher.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
platelet count
Item
patient has a platelet count of <50x10 9/l within 14 days before enrollment if not related to disease.
boolean
C0032181 (UMLS CUI [1])
absolute neutrophil count
Item
patient has an absolute neutrophil count less than 100 within 14 days before enrollment if not related to disease.
boolean
C0948762 (UMLS CUI [1])
creatinine clearance
Item
patient has a calculated or measured creatinine clearance of <20 ml/minute within 14 days before enrollment.
boolean
C0373595 (UMLS CUI [1])
peripheral neuropathy
Item
patient has > grade 2 peripheral neuropathy within 14 days before enrollment.
boolean
C0031117 (UMLS CUI [1])
total bilirubin
Item
patient has > 1.5 x uln total bilirubin.
boolean
C0201913 (UMLS CUI [1])
myocardial infarction; New York Heart Association Classification; Angina Pectoris; ventricular arrhythmia; electrocardiography
Item
myocardial infarction within 6 months prior to enrollment or has new york heart association class ii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
boolean
C0027051 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C0085612 (UMLS CUI [4])
C1623258 (UMLS CUI [5])
hypersensitivity bortezomib boron mannitol
Item
patient has hypersensitivity to bortezomib, boron or mannitol.
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0006030 (UMLS CUI [1,3])
C0024730 (UMLS CUI [1,4])
pregnancy; lactating
Item
female subject is pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status
Item
patient has received other investigational drugs within 14 days before enrollment.
boolean
C2348568 (UMLS CUI [1])
Compliance behavior Limited Comorbidity
Item
serious medical or psychiatric illness likely to interfere with participation in this clinical study.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
malignancy; basal cell carcinoma; squamous cell carcinoma; prostate cancer
Item
diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0007137 (UMLS CUI [3])
C0600139 (UMLS CUI [4])
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