ID

31481

Beschrijving

Lenalidomide, Vorinostat and Dexamethasone in Relapsed Patients With Peripheral T-Cell Non-Hodgkin's Lymphoma (PTCL); ODM derived from: https://clinicaltrials.gov/show/NCT00972842

Link

https://clinicaltrials.gov/show/NCT00972842

Trefwoorden

Versies (1)
  1. 27-08-18 27-08-18 -
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See clinicaltrials.gov

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27 augustus 2018

DOI

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Creative Commons BY 4.0
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Eligibility Peripheral T-Cell Non-Hodgkin's Lymphoma NCT00972842

Engels

Eligibility Peripheral T-Cell Non-Hodgkin's Lymphoma NCT00972842

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with relapsed ptcl according to who criteria who have received max. two previous treatments for ptcl
Beschrijving

Peripheral T-Cell Lymphoma Relapsed | Prior Therapy Quantity Peripheral T-Cell Lymphoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079774
UMLS CUI [1,2]
C0205336
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0079774
age ≥ 18 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
adequate bone marrow function i.e. absolute neutrophile count of > 1000/µl and thrombocytes > 75,000/µl.
Beschrijving

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
alkaline phosphatase and transaminases ≤ 2,5 x upper limit of normal (uln)
Beschrijving

Alkaline phosphatase measurement | Transaminase Assay

Datatype

boolean

Alias
UMLS CUI [1]
C0201850
UMLS CUI [2]
C0919834
total bilirubin ≤ 2,5 x uln
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
creatinine clearance ≥ 50 ml/min
Beschrijving

Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0373595
female subjects of childbearing potential† must: understand that the study medication could have an expected teratogenic risk and agree to use, and be able to comply with, effective contraception and agree to have a medically supervised pregnancy test
Beschrijving

Childbearing Potential Contraceptive methods | Comprehension Investigational New Drugs Risk Teratogenesis | Childbearing Potential Pregnancy Test

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0035647
UMLS CUI [2,4]
C0232910
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0032976
male subjects must agree to use condoms and agree not to donate semen
Beschrijving

Gender | Male condom contraception | Sperm donation Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0850360
UMLS CUI [3,1]
C0871414
UMLS CUI [3,2]
C0332197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior history of malignancies, other than ptcl, unless the subject has been free of the disease for ≥ 3 years
Beschrijving

Cancer Other | Exception Disease Free of

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
prior allogeneic bone marrow transplant or plans to undergo autologous/ allogeneic bone marrow transplant within 4 weeks of the initiation of vorinostat administration
Beschrijving

Allogeneic bone marrow transplantation | Autologous bone marrow transplant Planned | Allogeneic bone marrow transplantation Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0149615
UMLS CUI [2,1]
C0194037
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C0149615
UMLS CUI [3,2]
C1301732
prior treatment with a hdac inhibitor
Beschrijving

Histone deacetylase inhibitor

Datatype

boolean

Alias
UMLS CUI [1]
C1512474
prior treatment with lenalidomide (patients previously treated with thalidomide may be enrolled)
Beschrijving

Lenalidomide | Prior Therapy Thalidomide allowed

Datatype

boolean

Alias
UMLS CUI [1]
C1144149
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0039736
UMLS CUI [2,3]
C0683607
known history of deep vein thrombosis (dvt) and/ or pulmonary embolism (pe)
Beschrijving

Deep Vein Thrombosis | Pulmonary Embolism

Datatype

boolean

Alias
UMLS CUI [1]
C0149871
UMLS CUI [2]
C0034065
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Similar models

Eligibility Peripheral T-Cell Non-Hodgkin's Lymphoma NCT00972842

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Peripheral T-Cell Lymphoma Relapsed | Prior Therapy Quantity Peripheral T-Cell Lymphoma
Item
patients with relapsed ptcl according to who criteria who have received max. two previous treatments for ptcl
boolean
C0079774 (UMLS CUI [1,1])
C0205336 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0079774 (UMLS CUI [2,3])
Age
Item
age ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
Item
adequate bone marrow function i.e. absolute neutrophile count of > 1000/µl and thrombocytes > 75,000/µl.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Alkaline phosphatase measurement | Transaminase Assay
Item
alkaline phosphatase and transaminases ≤ 2,5 x upper limit of normal (uln)
boolean
C0201850 (UMLS CUI [1])
C0919834 (UMLS CUI [2])
Serum total bilirubin measurement
Item
total bilirubin ≤ 2,5 x uln
boolean
C1278039 (UMLS CUI [1])
Creatinine clearance measurement
Item
creatinine clearance ≥ 50 ml/min
boolean
C0373595 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Comprehension Investigational New Drugs Risk Teratogenesis | Childbearing Potential Pregnancy Test
Item
female subjects of childbearing potential† must: understand that the study medication could have an expected teratogenic risk and agree to use, and be able to comply with, effective contraception and agree to have a medically supervised pregnancy test
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0035647 (UMLS CUI [2,3])
C0232910 (UMLS CUI [2,4])
C3831118 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
Gender | Male condom contraception | Sperm donation Absent
Item
male subjects must agree to use condoms and agree not to donate semen
boolean
C0079399 (UMLS CUI [1])
C0850360 (UMLS CUI [2])
C0871414 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Exception Disease Free of
Item
prior history of malignancies, other than ptcl, unless the subject has been free of the disease for ≥ 3 years
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
Allogeneic bone marrow transplantation | Autologous bone marrow transplant Planned | Allogeneic bone marrow transplantation Planned
Item
prior allogeneic bone marrow transplant or plans to undergo autologous/ allogeneic bone marrow transplant within 4 weeks of the initiation of vorinostat administration
boolean
C0149615 (UMLS CUI [1])
C0194037 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0149615 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Histone deacetylase inhibitor
Item
prior treatment with a hdac inhibitor
boolean
C1512474 (UMLS CUI [1])
Lenalidomide | Prior Therapy Thalidomide allowed
Item
prior treatment with lenalidomide (patients previously treated with thalidomide may be enrolled)
boolean
C1144149 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C0039736 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Deep Vein Thrombosis | Pulmonary Embolism
Item
known history of deep vein thrombosis (dvt) and/ or pulmonary embolism (pe)
boolean
C0149871 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
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