ID

26003

Beschrijving

Oxaliplatin and Prednisolone (Ox-P) for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma(MZL); ODM derived from: https://clinicaltrials.gov/show/NCT01068392

Link

https://clinicaltrials.gov/show/NCT01068392

Trefwoorden

Versies (2)
  1. 02-10-17 02-10-17 -
  2. 04-10-17 04-10-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

4 oktober 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility B-cell Lymphomas NCT01068392

Engels

Eligibility B-cell Lymphomas NCT01068392

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed marginal zone b-cell lymphomas
Beschrijving

Marginal Zone B-Cell Lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C1367654
failure to achieve a clinical benefit (≥sd) with the initial treatment, or recurrent disease
Beschrijving

Neoadjuvant Therapy | Stable Disease failed | Recurrent disease

Datatype

boolean

Alias
UMLS CUI [1]
C0600558
UMLS CUI [2,1]
C0677946
UMLS CUI [2,2]
C0231175
UMLS CUI [3]
C0277556
performance status (ecog) ≤2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
age ≥ 20
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
at least one or more bi-dimensionally measurable lesion(s) defined as; ≥2 cm by conventional ct or ≥ 1 cm by spiral ct or skin lesion (photographs should be taken) or measurable lesion by physical examination
Beschrijving

Measurable Disease 2-Dimensional Quantity CT | Measurable Disease 2-Dimensional Quantity Spiral CT | Skin lesion Photograph | Measurable Disease Physical Examination

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0040405
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1705052
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0860888
UMLS CUI [3,1]
C0037284
UMLS CUI [3,2]
C0441468
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C0031809
adequate kidney functions defined as; cr < 2.0 mg% or ccr > 60 ml/min
Beschrijving

Renal function | Creatinine measurement, serum | Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
adequate liver functions defined as; transaminases < 3 x upper normal values; bilirubin < 2 mg%
Beschrijving

Liver function | Transaminases | Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0002594
UMLS CUI [3]
C1278039
adequate bone marrow functions defined as; anc > 1500/㎕, platelet > 75000/㎕
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
ann arbor stage iii or iv
Beschrijving

Ann Arbor lymphoma staging system

Datatype

boolean

Alias
UMLS CUI [1]
C0432516
ann arbor stage i or ii, which is not adequate for rt or surgical approach (e.g. multiple lung lesions, multiple colon involvement, remote abdominal ln with stomach involvement)
Beschrijving

Ann Arbor lymphoma staging system | Stage Inappropriate Therapeutic radiology procedure | Stage Inappropriate Surgical approach | Lesion of lung multiple | Involvement with Colon multiple | Abdominal lymph nodes Remote Involvement with Stomach

Datatype

boolean

Alias
UMLS CUI [1]
C0432516
UMLS CUI [2,1]
C1300072
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C1522449
UMLS CUI [3,1]
C1300072
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C0449446
UMLS CUI [4,1]
C0577916
UMLS CUI [4,2]
C0439064
UMLS CUI [5,1]
C1314939
UMLS CUI [5,2]
C1281569
UMLS CUI [5,3]
C0439064
UMLS CUI [6,1]
C0588058
UMLS CUI [6,2]
C0205157
UMLS CUI [6,3]
C1314939
UMLS CUI [6,4]
C0038351
written informed consent approved by institutional review board or ethic committee
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
any other malignancies within the past 5 years except skin basal cell ca or cis of cervix
Beschrijving

Malignant Neoplasms | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
serious co-morbid diseases
Beschrijving

Comorbidity Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
pregnancy or breast feeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
previous history of drug allergy to one of the drugs in the study regimen
Beschrijving

Hypersensitivity Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
during this study duration, patients who take other clinical trial medication, chemotherapy, hormonal therapy, or immunotherapy
Beschrijving

Investigational New Drugs | Chemotherapy | Hormone Therapy | Immunotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0279025
UMLS CUI [4]
C0021083
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Similar models

Eligibility B-cell Lymphomas NCT01068392

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Marginal Zone B-Cell Lymphoma
Item
histologically confirmed marginal zone b-cell lymphomas
boolean
C1367654 (UMLS CUI [1])
Neoadjuvant Therapy | Stable Disease failed | Recurrent disease
Item
failure to achieve a clinical benefit (≥sd) with the initial treatment, or recurrent disease
boolean
C0600558 (UMLS CUI [1])
C0677946 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0277556 (UMLS CUI [3])
ECOG performance status
Item
performance status (ecog) ≤2
boolean
C1520224 (UMLS CUI [1])
Age
Item
age ≥ 20
boolean
C0001779 (UMLS CUI [1])
Measurable Disease 2-Dimensional Quantity CT | Measurable Disease 2-Dimensional Quantity Spiral CT | Skin lesion Photograph | Measurable Disease Physical Examination
Item
at least one or more bi-dimensionally measurable lesion(s) defined as; ≥2 cm by conventional ct or ≥ 1 cm by spiral ct or skin lesion (photographs should be taken) or measurable lesion by physical examination
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0040405 (UMLS CUI [1,4])
C1513041 (UMLS CUI [2,1])
C1705052 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0860888 (UMLS CUI [2,4])
C0037284 (UMLS CUI [3,1])
C0441468 (UMLS CUI [3,2])
C1513041 (UMLS CUI [4,1])
C0031809 (UMLS CUI [4,2])
Renal function | Creatinine measurement, serum | Creatinine clearance measurement
Item
adequate kidney functions defined as; cr < 2.0 mg% or ccr > 60 ml/min
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Liver function | Transaminases | Serum total bilirubin measurement
Item
adequate liver functions defined as; transaminases < 3 x upper normal values; bilirubin < 2 mg%
boolean
C0232741 (UMLS CUI [1])
C0002594 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
Item
adequate bone marrow functions defined as; anc > 1500/㎕, platelet > 75000/㎕
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Ann Arbor lymphoma staging system
Item
ann arbor stage iii or iv
boolean
C0432516 (UMLS CUI [1])
Ann Arbor lymphoma staging system | Stage Inappropriate Therapeutic radiology procedure | Stage Inappropriate Surgical approach | Lesion of lung multiple | Involvement with Colon multiple | Abdominal lymph nodes Remote Involvement with Stomach
Item
ann arbor stage i or ii, which is not adequate for rt or surgical approach (e.g. multiple lung lesions, multiple colon involvement, remote abdominal ln with stomach involvement)
boolean
C0432516 (UMLS CUI [1])
C1300072 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
C1300072 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0449446 (UMLS CUI [3,3])
C0577916 (UMLS CUI [4,1])
C0439064 (UMLS CUI [4,2])
C1314939 (UMLS CUI [5,1])
C1281569 (UMLS CUI [5,2])
C0439064 (UMLS CUI [5,3])
C0588058 (UMLS CUI [6,1])
C0205157 (UMLS CUI [6,2])
C1314939 (UMLS CUI [6,3])
C0038351 (UMLS CUI [6,4])
Informed Consent
Item
written informed consent approved by institutional review board or ethic committee
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
any other malignancies within the past 5 years except skin basal cell ca or cis of cervix
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Comorbidity Serious
Item
serious co-morbid diseases
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Investigational New Drugs
Item
previous history of drug allergy to one of the drugs in the study regimen
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Investigational New Drugs | Chemotherapy | Hormone Therapy | Immunotherapy
Item
during this study duration, patients who take other clinical trial medication, chemotherapy, hormonal therapy, or immunotherapy
boolean
C0013230 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
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