ID

30399

Beschrijving

GM-CSF and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00893477

Link

https://clinicaltrials.gov/show/NCT00893477

Trefwoorden

Versies (1)
  1. 02-06-18 02-06-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

2 juni 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00893477

Engels

Eligibility Lymphoma NCT00893477

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00893477
Criteria
Beschrijving

Criteria

histologically and immunophenotypically confirmed cd20+ follicular lymphoma according to who classification
Beschrijving

Follicular Lymphoma CD20 positive Immunophenotyping WHO tumor classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0882818
UMLS CUI [1,3]
C0079611
UMLS CUI [1,4]
C1301142
grade 1-3a disease
Beschrijving

Disease Ann Arbor lymphoma staging system

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0432516
stage ii-iv disease
Beschrijving

Disease Ann Arbor lymphoma staging system

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0432516
non-bulky disease
Beschrijving

Disease Except Bulky Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C1511341
must have undergone initial nodal biopsy within the past 4 months
Beschrijving

Lymph nodes Biopsy Required

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C1514873
at least 1 measurable lesion
Beschrijving

Measurable lesion Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
low tumor-burden, as defined by the following gelf criteria:
Beschrijving

Tumor Burden low

Datatype

boolean

Alias
UMLS CUI [1,1]
C1449699
UMLS CUI [1,2]
C0205251
nodal or extranodal tumor mass (diameter < 7 cm)
Beschrijving

Tumor Mass nodal Diameter Size | Tumor Mass Extranodal Diameter Size

Datatype

boolean

Alias
UMLS CUI [1,1]
C3273930
UMLS CUI [1,2]
C0443268
UMLS CUI [1,3]
C1301886
UMLS CUI [1,4]
C0456389
UMLS CUI [2,1]
C3273930
UMLS CUI [2,2]
C1517067
UMLS CUI [2,3]
C1301886
UMLS CUI [2,4]
C0456389
no systemic b symptoms
Beschrijving

Exclusion B-Symptoms Systemic

Datatype

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C1706867
UMLS CUI [1,3]
C0205373
no increased ldh and β2 microglobulinemia
Beschrijving

Exclusion Criteria | Increased LDH | Serum beta2 microglobulin increased

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C1848823
UMLS CUI [3]
C0859328
no substantial splenic enlargement
Beschrijving

Exclusion Splenomegaly Significant

Datatype

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0038002
UMLS CUI [1,3]
C0750502
no serous effusion
Beschrijving

Exclusion Serous effusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0302149
no compression syndrome
Beschrijving

Exclusion Compression syndrome

Datatype

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C1393567
patient characteristics:
Beschrijving

Client Characteristics

Datatype

boolean

Alias
UMLS CUI [1]
C0815172
ecog performance status 0-1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
negative pregnancy test
Beschrijving

Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use effective contraception
Beschrijving

Fertility Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no active hepatitis
Beschrijving

Exclusion Hepatitis

Datatype

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0019158
prior concurrent therapy:
Beschrijving

Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0087111
no prior treatment, including steroids and radiotherapy
Beschrijving

Exclusion Criteria | Prior Therapy | Steroids | Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C1514463
UMLS CUI [3]
C0038317
UMLS CUI [4]
C1522449
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Similar models

Eligibility Lymphoma NCT00893477

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00893477
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Follicular Lymphoma CD20 positive Immunophenotyping WHO tumor classification
Item
histologically and immunophenotypically confirmed cd20+ follicular lymphoma according to who classification
boolean
C0024301 (UMLS CUI [1,1])
C0882818 (UMLS CUI [1,2])
C0079611 (UMLS CUI [1,3])
C1301142 (UMLS CUI [1,4])
Disease Ann Arbor lymphoma staging system
Item
grade 1-3a disease
boolean
C0012634 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
Disease Ann Arbor lymphoma staging system
Item
stage ii-iv disease
boolean
C0012634 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
Disease Except Bulky Disease
Item
non-bulky disease
boolean
C0012634 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C1511341 (UMLS CUI [1,3])
Lymph nodes Biopsy Required
Item
must have undergone initial nodal biopsy within the past 4 months
boolean
C0024204 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
Measurable lesion Quantity
Item
at least 1 measurable lesion
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Tumor Burden low
Item
low tumor-burden, as defined by the following gelf criteria:
boolean
C1449699 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
Tumor Mass nodal Diameter Size | Tumor Mass Extranodal Diameter Size
Item
nodal or extranodal tumor mass (diameter < 7 cm)
boolean
C3273930 (UMLS CUI [1,1])
C0443268 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,4])
C3273930 (UMLS CUI [2,1])
C1517067 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C0456389 (UMLS CUI [2,4])
Exclusion B-Symptoms Systemic
Item
no systemic b symptoms
boolean
C2828389 (UMLS CUI [1,1])
C1706867 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
Exclusion Criteria | Increased LDH | Serum beta2 microglobulin increased
Item
no increased ldh and β2 microglobulinemia
boolean
C0680251 (UMLS CUI [1])
C1848823 (UMLS CUI [2])
C0859328 (UMLS CUI [3])
Exclusion Splenomegaly Significant
Item
no substantial splenic enlargement
boolean
C2828389 (UMLS CUI [1,1])
C0038002 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
Exclusion Serous effusion
Item
no serous effusion
boolean
C2828389 (UMLS CUI [1,1])
C0302149 (UMLS CUI [1,2])
Exclusion Compression syndrome
Item
no compression syndrome
boolean
C2828389 (UMLS CUI [1,1])
C1393567 (UMLS CUI [1,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Exclusion Hepatitis
Item
no active hepatitis
boolean
C2828389 (UMLS CUI [1,1])
C0019158 (UMLS CUI [1,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Exclusion Criteria | Prior Therapy | Steroids | Therapeutic radiology procedure
Item
no prior treatment, including steroids and radiotherapy
boolean
C0680251 (UMLS CUI [1])
C1514463 (UMLS CUI [2])
C0038317 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
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