ID

27736

Beskrivning

Methotrexate, Glucarpidase, and Leucovorin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00727831

Länk

https://clinicaltrials.gov/show/NCT00727831

Nyckelord

  1. 2017-11-27 2017-11-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 november 2017

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Chemotherapeutic Agent Toxicity NCT00727831

Eligibility Chemotherapeutic Agent Toxicity NCT00727831

Criteria
Beskrivning

Criteria

histologically confirmed newly diagnosed primary cns lymphoma (pcnsl)
Beskrivning

Primary central nervous system lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0280803
previously untreated disease
Beskrivning

Disease untreated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332155
diffuse large b-cell lymphoma histology
Beskrivning

Diffuse Large B-Cell Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0079744
must be clinically eligible to receive standard 3 g/m² methotrexate if outside trial
Beskrivning

Methotrexate Dose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
no clinically significant effusions or edema
Beskrivning

Effusion Absent | Edema Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013687
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0013604
UMLS CUI [2,2]
C0332197
patient characteristics:
Beskrivning

Client Characteristics

Datatyp

boolean

Alias
UMLS CUI [1]
C0815172
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
ecog performance status 0-3
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
neutrophils ≥ 1 x 10^9/l
Beskrivning

Neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0200633
platelet count ≥ 100 x 10^9/l
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
bilirubin < 1.5 times upper limit of normal
Beskrivning

Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
glomerular filtration rate (initially measured by edta/isotope method) ≥ 50 ml/min
Beskrivning

Glomerular Filtration Rate EDTA Method

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0017654
UMLS CUI [1,2]
C0013618
UMLS CUI [1,3]
C0025663
not pregnant or nursing
Beskrivning

Pregnancy Absent | Breast Feeding Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
negative pregnancy test
Beskrivning

Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use effective contraception during and for 6 months after completion of study therapy
Beskrivning

Fertility Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
hiv positivity
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
dementia or neurological dysfunction not considered to be due to the pcnsl
Beskrivning

Dementia | Neurological Dysfunction | Primary central nervous system lymphoma Uninvolved

Datatyp

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C1709219
UMLS CUI [3,1]
C0280803
UMLS CUI [3,2]
C0205429
other serious or uncontrolled medical conditions
Beskrivning

Medical condition Serious | Medical condition Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205318
prior malignancy, except adequately treated nonmelanoma skin cancer or carcinoma in situ
Beskrivning

Cancer Other | Exception Skin carcinoma Treated | Exception Carcinoma in Situ Treated

Datatyp

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]
C0007099
UMLS CUI [3,3]
C1522326
prior concurrent therapy:
Beskrivning

Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0087111
no prior cytotoxic chemotherapy
Beskrivning

Cytotoxic Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0677881
no concurrent prophylactic antibiotics
Beskrivning

Prophylactic antibiotic

Datatyp

boolean

Alias
UMLS CUI [1]
C0362063
no concurrent co-trimoxazole
Beskrivning

co-trimoxazole

Datatyp

boolean

Alias
UMLS CUI [1]
C0041044

Similar models

Eligibility Chemotherapeutic Agent Toxicity NCT00727831

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Primary central nervous system lymphoma
Item
histologically confirmed newly diagnosed primary cns lymphoma (pcnsl)
boolean
C0280803 (UMLS CUI [1])
Disease untreated
Item
previously untreated disease
boolean
C0012634 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Diffuse Large B-Cell Lymphoma
Item
diffuse large b-cell lymphoma histology
boolean
C0079744 (UMLS CUI [1])
Methotrexate Dose
Item
must be clinically eligible to receive standard 3 g/m² methotrexate if outside trial
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Effusion Absent | Edema Absent
Item
no clinically significant effusions or edema
boolean
C0013687 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0013604 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Item Group
C1512693 (UMLS CUI)
ECOG performance status
Item
ecog performance status 0-3
boolean
C1520224 (UMLS CUI [1])
Neutrophil count
Item
neutrophils ≥ 1 x 10^9/l
boolean
C0200633 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 100 x 10^9/l
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin < 1.5 times upper limit of normal
boolean
C1278039 (UMLS CUI [1])
Glomerular Filtration Rate EDTA Method
Item
glomerular filtration rate (initially measured by edta/isotope method) ≥ 50 ml/min
boolean
C0017654 (UMLS CUI [1,1])
C0013618 (UMLS CUI [1,2])
C0025663 (UMLS CUI [1,3])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception during and for 6 months after completion of study therapy
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
HIV Seropositivity
Item
hiv positivity
boolean
C0019699 (UMLS CUI [1])
Dementia | Neurological Dysfunction | Primary central nervous system lymphoma Uninvolved
Item
dementia or neurological dysfunction not considered to be due to the pcnsl
boolean
C0497327 (UMLS CUI [1])
C1709219 (UMLS CUI [2])
C0280803 (UMLS CUI [3,1])
C0205429 (UMLS CUI [3,2])
Medical condition Serious | Medical condition Uncontrolled
Item
other serious or uncontrolled medical conditions
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Cancer Other | Exception Skin carcinoma Treated | Exception Carcinoma in Situ Treated
Item
prior malignancy, except adequately treated nonmelanoma skin cancer or carcinoma in situ
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])
C0007099 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Cytotoxic Chemotherapy
Item
no prior cytotoxic chemotherapy
boolean
C0677881 (UMLS CUI [1])
Prophylactic antibiotic
Item
no concurrent prophylactic antibiotics
boolean
C0362063 (UMLS CUI [1])
co-trimoxazole
Item
no concurrent co-trimoxazole
boolean
C0041044 (UMLS CUI [1])

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