ID

31478

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00865969

Stichworte

Versionen (1)
  1. 27.08.18 27.08.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

27. August 2018

DOI

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Eligibility Peripheral T-cell Lymphoma NCT00865969

Englisch

Eligibility Peripheral T-cell Lymphoma NCT00865969

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
a histologically confirmed diagnosis of ptcl
Beschreibung

Peripheral T-Cell Lymphoma

Datentyp

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.
Beschreibung

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

Datentyp

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).
Beschreibung

Measurable Disease Site Quantity | Measurable Disease 2-Dimensional CT

Datentyp

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.
Beschreibung

Age

Datentyp

boolean

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

Bone Marrow function | Liver function | Renal function

Datentyp

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.
Beschreibung

ECOG performance status

Datentyp

boolean

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

Childbearing Potential Pregnancy test negative

Datentyp

boolean

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

Exclusion Criteria

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

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

Datentyp

boolean

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

Histone deacetylase inhibitor

Datentyp

boolean

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

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

Datentyp

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.
Beschreibung

Cardiovascular Disease Severe

Datentyp

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.
Beschreibung

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

Datentyp

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).
Beschreibung

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

Datentyp

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.
Beschreibung

CNS metastases Symptomatic | CNS metastases Untreated

Datentyp

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.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

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

HIV Infection | Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
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Ähnliche Modelle

Eligibility Peripheral T-cell Lymphoma NCT00865969

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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