ID

31478

Descripción

Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00865969

Link

https://clinicaltrials.gov/show/NCT00865969

Palabras clave

Versiones (1)
  1. 27/8/18 27/8/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

27 de agosto de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Peripheral T-cell Lymphoma NCT00865969

Inglés

Eligibility Peripheral T-cell Lymphoma NCT00865969

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
a histologically confirmed diagnosis of ptcl
Descripción

Peripheral T-Cell Lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079774
patients must have relapsed or refractory disease after at least one prior systemic anticancer regimen. systemic anticancer therapy is defined as chemotherapy or immunotherapy administered systemically.
Descripción

Recurrent disease | Refractory Disease | Status post Cancer treatment Systemic Quantity | Systemic Chemotherapy | Immunotherapy Systemic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1514815
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0920425
UMLS CUI [3,3]
C0205373
UMLS CUI [3,4]
C1265611
UMLS CUI [4]
C1883256
UMLS CUI [5,1]
C0021083
UMLS CUI [5,2]
C0205373
patients must have at least one site of disease measurable in two dimensions by computed tomography (ct).
Descripción

Measurable Disease Site Quantity | Measurable Disease 2-Dimensional CT

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1705052
UMLS CUI [2,3]
C0040405
age ≥ 18 years.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
adequate bone marrow, liver, and renal functions.
Descripción

Bone Marrow function | Liver function | Renal function

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
eastern cooperative oncology group (ecog) performance status 0-2.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
negative pregnancy test for women of childbearing potential.
Descripción

Childbearing Potential Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
relapse within 100 days of autologous or allogeneic bone marrow transplant.
Descripción

Recurrent disease | Autologous bone marrow transplant | Allogeneic bone marrow transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C0194037
UMLS CUI [3]
C0149615
prior hdac inhibitor therapy.
Descripción

Histone deacetylase inhibitor

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1512474
co-existing active infection or any medical condition likely to interfere with trial procedures.
Descripción

Communicable Disease Interferes with Clinical Trial Procedure | Medical condition Interferes with Clinical Trial Procedure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0184661
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0008976
UMLS CUI [2,4]
C0184661
severe cardiovascular disease.
Descripción

Cardiovascular Disease Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205082
clinically significant central nervous system disorders with altered mental status or psychiatric disorders precluding understanding of the informed consent process and/or completion of the necessary studies.
Descripción

CNS disorder Associated with Abnormal mental state | Mental disorders Exclude Comprehension Informed Consent | Mental disorders Exclude Completion of clinical trial

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0278061
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0162340
UMLS CUI [2,4]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C2732579
active concurrent malignancy (except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix).
Descripción

Cancer Other | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1522326
symptomatic or untreated central nervous system (cns) metastases.
Descripción

CNS metastases Symptomatic | CNS metastases Untreated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0332155
pregnant or breast-feeding women.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known infection with hiv, hepatitis b or hepatitis c.
Descripción

HIV Infection | Hepatitis B | Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
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Similar models

Eligibility Peripheral T-cell Lymphoma NCT00865969

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Peripheral T-Cell Lymphoma
Item
a histologically confirmed diagnosis of ptcl
boolean
C0079774 (UMLS CUI [1])
Recurrent disease | Refractory Disease | Status post Cancer treatment Systemic Quantity | Systemic Chemotherapy | Immunotherapy Systemic
Item
patients must have relapsed or refractory disease after at least one prior systemic anticancer regimen. systemic anticancer therapy is defined as chemotherapy or immunotherapy administered systemically.
boolean
C0277556 (UMLS CUI [1])
C1514815 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0920425 (UMLS CUI [3,2])
C0205373 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
C1883256 (UMLS CUI [4])
C0021083 (UMLS CUI [5,1])
C0205373 (UMLS CUI [5,2])
Measurable Disease Site Quantity | Measurable Disease 2-Dimensional CT
Item
patients must have at least one site of disease measurable in two dimensions by computed tomography (ct).
boolean
C1513041 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C1705052 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
Age
Item
age ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, liver, and renal functions.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
negative pregnancy test for women of childbearing potential.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Recurrent disease | Autologous bone marrow transplant | Allogeneic bone marrow transplantation
Item
relapse within 100 days of autologous or allogeneic bone marrow transplant.
boolean
C0277556 (UMLS CUI [1])
C0194037 (UMLS CUI [2])
C0149615 (UMLS CUI [3])
Histone deacetylase inhibitor
Item
prior hdac inhibitor therapy.
boolean
C1512474 (UMLS CUI [1])
Communicable Disease Interferes with Clinical Trial Procedure | Medical condition Interferes with Clinical Trial Procedure
Item
co-existing active infection or any medical condition likely to interfere with trial procedures.
boolean
C0009450 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0184661 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0184661 (UMLS CUI [2,4])
Cardiovascular Disease Severe
Item
severe cardiovascular disease.
boolean
C0007222 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
CNS disorder Associated with Abnormal mental state | Mental disorders Exclude Comprehension Informed Consent | Mental disorders Exclude Completion of clinical trial
Item
clinically significant central nervous system disorders with altered mental status or psychiatric disorders precluding understanding of the informed consent process and/or completion of the necessary studies.
boolean
C0007682 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0278061 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0162340 (UMLS CUI [2,3])
C0021430 (UMLS CUI [2,4])
C0004936 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
Cancer Other | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
active concurrent malignancy (except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix).
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
CNS metastases Symptomatic | CNS metastases Untreated
Item
symptomatic or untreated central nervous system (cns) metastases.
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Infection | Hepatitis B | Hepatitis C
Item
known infection with hiv, hepatitis b or hepatitis c.
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
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