ID

12863

Descripción

Bendamustine, Carboplatin and Dexamethasone (BCD) for Refractory or Relapsed Peripheral T-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02424045

Link

https://clinicaltrials.gov/show/NCT02424045

Palabras clave

Versiones (1)
  1. 3/1/16 3/1/16 -
Subido en

3 de enero de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility T-cell Lymphoma NCT02424045

Inglés

Eligibility T-cell Lymphoma NCT02424045

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically proven aggressive t-cell non-hodgkin's lymphoma (nhl)
Descripción

t-cell non-hodgkins lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079772
2. age 18 -75 years
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
3. ann arbor stage ii, iii and iv (appendix a)
Descripción

Lymphoma stage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272836
4. relapsed or refractory cases to previous treatments
Descripción

relapse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0277556
5. performance status (ecog) ≤ 2 (appendix b)
Descripción

ecog

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
6. at least one or more bidimensionally measurable lesion(s)
Descripción

lesion measurable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1513040
≥ 2 cm by conventional ct
Descripción

conventional tomography

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2137222
≥ 1 cm by spiral ct
Descripción

spiral ct

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0860888
skin lesion (photographs should be taken) ≥ 2 cm
Descripción

skin lesion

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0037284
measurable lesion by physical examination ≥ 2 cm
Descripción

lesion measurable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1513040
7. cardiac ejection fraction ≥ 50 % as measured by muga or 2decho without clinically significant abnormalities
Descripción

cardiac ejection fraction; muga abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232174
UMLS CUI [2]
C0853480
8. adequate renal function: serum creatinine level < 2 mg/dl (177 μmol/l)
Descripción

renal function adequate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0205411
9. adequate liver functions: transaminase (ast/alt) < 3 x upper normal value (or < 5 x uln in the presence of dlbcl involvement of the liver), bilirubin < 2 x upper normal value (or < 5 x uln in the presence of ptcl involvement of the liver)
Descripción

liver function adequate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205411
10. adequate bm functions: hemoglobin ≥ 9 g/dl absolute neutrophil count (anc) ≥ 1,500/μl and platelet count ≥ 75,000/μl, unless abnormalities are due to bone marrow involvement by lymphoma
Descripción

organ function bone marrow adequate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0205411
11. a negative serum or urine pregnancy test prior to treatment must be available both for pre-menopausal women and for women who are < 1years after the onset of menopause.
Descripción

negative pregnancy test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0427780
12. informed consent
Descripción

informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. alk-positive anaplastic large cell lymphoma and sezary syndrome.
Descripción

alk-positive anaplastic large cell lymphoma; sezary syndrome

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1332079
UMLS CUI [2]
C0036920
2. cns or testis involvement.
Descripción

Site of involvement Central Nervous System testis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0449683
UMLS CUI [1,2]
C3714787
UMLS CUI [1,3]
C0039597
3. previously treated with the regimen containing bendamustine or platinum agents.
Descripción

bendamustine; platinum agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525079
UMLS CUI [2]
C3536920
4. any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
Descripción

Comorbidity Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0006826
5. pregnant or lactating women, women of childbearing potential not employing adequate contraception
Descripción

pregnancy; lactating

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
6. other serious illness or medical conditions
Descripción

Comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
7. unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
Descripción

cardiac disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018799
8. history of significant neurologic or psychiatric disorders including dementia or seizures
Descripción

Mental disorders; dementia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0497327
9. active uncontrolled infection (viral, bacterial or fungal infection)
Descripción

comorbidity infection

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C3714514
10. other serious medical illnesses
Descripción

comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
11. known hypersensitivity to any of the study drugs or its ingredients
Descripción

hypersensitivity Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
12. concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
Descripción

concomitant medication

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2347852
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Similar models

Eligibility T-cell Lymphoma NCT02424045

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
t-cell non-hodgkins lymphoma
Item
1. histologically proven aggressive t-cell non-hodgkin's lymphoma (nhl)
boolean
C0079772 (UMLS CUI [1])
age
Item
2. age 18 -75 years
boolean
C0001779 (UMLS CUI [1])
Lymphoma stage
Item
3. ann arbor stage ii, iii and iv (appendix a)
boolean
C1272836 (UMLS CUI [1])
relapse
Item
4. relapsed or refractory cases to previous treatments
boolean
C0277556 (UMLS CUI [1])
ecog
Item
5. performance status (ecog) ≤ 2 (appendix b)
boolean
C1520224 (UMLS CUI [1])
lesion measurable
Item
6. at least one or more bidimensionally measurable lesion(s)
boolean
C0221198 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
conventional tomography
Item
≥ 2 cm by conventional ct
boolean
C2137222 (UMLS CUI [1])
spiral ct
Item
≥ 1 cm by spiral ct
boolean
C0860888 (UMLS CUI [1])
skin lesion
Item
skin lesion (photographs should be taken) ≥ 2 cm
boolean
C0037284 (UMLS CUI [1])
lesion measurable
Item
measurable lesion by physical examination ≥ 2 cm
boolean
C0221198 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
cardiac ejection fraction; muga abnormal
Item
7. cardiac ejection fraction ≥ 50 % as measured by muga or 2decho without clinically significant abnormalities
boolean
C0232174 (UMLS CUI [1])
C0853480 (UMLS CUI [2])
renal function adequate
Item
8. adequate renal function: serum creatinine level < 2 mg/dl (177 μmol/l)
boolean
C0232804 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
liver function adequate
Item
9. adequate liver functions: transaminase (ast/alt) < 3 x upper normal value (or < 5 x uln in the presence of dlbcl involvement of the liver), bilirubin < 2 x upper normal value (or < 5 x uln in the presence of ptcl involvement of the liver)
boolean
C0232741 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
organ function bone marrow adequate
Item
10. adequate bm functions: hemoglobin ≥ 9 g/dl absolute neutrophil count (anc) ≥ 1,500/μl and platelet count ≥ 75,000/μl, unless abnormalities are due to bone marrow involvement by lymphoma
boolean
C0678852 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,3])
negative pregnancy test
Item
11. a negative serum or urine pregnancy test prior to treatment must be available both for pre-menopausal women and for women who are < 1years after the onset of menopause.
boolean
C0427780 (UMLS CUI [1])
informed consent
Item
12. informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
alk-positive anaplastic large cell lymphoma; sezary syndrome
Item
1. alk-positive anaplastic large cell lymphoma and sezary syndrome.
boolean
C1332079 (UMLS CUI [1])
C0036920 (UMLS CUI [2])
Site of involvement Central Nervous System testis
Item
2. cns or testis involvement.
boolean
C0449683 (UMLS CUI [1,1])
C3714787 (UMLS CUI [1,2])
C0039597 (UMLS CUI [1,3])
bendamustine; platinum agents
Item
3. previously treated with the regimen containing bendamustine or platinum agents.
boolean
C0525079 (UMLS CUI [1])
C3536920 (UMLS CUI [2])
Comorbidity Malignant Neoplasms
Item
4. any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
boolean
C0009488 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
pregnancy; lactating
Item
5. pregnant or lactating women, women of childbearing potential not employing adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity
Item
6. other serious illness or medical conditions
boolean
C0009488 (UMLS CUI [1])
cardiac disease
Item
7. unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
boolean
C0018799 (UMLS CUI [1])
Mental disorders; dementia
Item
8. history of significant neurologic or psychiatric disorders including dementia or seizures
boolean
C0004936 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
comorbidity infection
Item
9. active uncontrolled infection (viral, bacterial or fungal infection)
boolean
C0009488 (UMLS CUI [1,1])
C3714514 (UMLS CUI [1,2])
comorbidity
Item
10. other serious medical illnesses
boolean
C0009488 (UMLS CUI [1])
hypersensitivity Investigational New Drugs
Item
11. known hypersensitivity to any of the study drugs or its ingredients
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
concomitant medication
Item
12. concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
boolean
C2347852 (UMLS CUI [1])
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