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Information:
Fel:
ID
30356
Beskrivning
An Study of Patients With Lymphoma Who Take R-CHOP and Enzastaurin Compared to Patients Who Take R-CHOP Only; ODM derived from: https://clinicaltrials.gov/show/NCT00451178
Länk
https://clinicaltrials.gov/show/NCT00451178
Nyckelord
Versioner (3)
- 2018-05-29 2018-05-29 -
- 2018-05-29 2018-05-29 -
- 2018-05-29 2018-05-29 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
29 maj 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Eligibility Lymphoma NCT00451178
Eligibility Lymphoma NCT00451178
- StudyEvent: Eligibility
Similar models
Eligibility Lymphoma NCT00451178
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Criteria Fulfill
Item
patients must:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,2])
ID.2
Item
1. have a histologically confirmed diagnosis of dlbcl based on the world health organization classification (harris et al. 1999) at the time of original diagnosis. pathology must be reviewed and confirmed prior to enrollment at the investigational site where the patient is entered. patients with a prior history of an indolent lymphoma or a histological diagnosis of follicular grade 3 lymphoma will not be eligible for enrollment.
boolean
Prior Chemotherapy Absent
Item
2. have received no prior chemotherapy.
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,2])
IPI
Item
3. have an ipi score > or = to 2 at time of original diagnosis.
boolean
C1512894 (UMLS CUI [1])
ECOG performance status
Item
4. have a performance status of 0, 1, or 2 on the eastern cooperative oncology group (ecog) scale.
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
5. have adequate organ function as follows:
boolean
C0678852 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Liver Involvement
Item
hepatic: total bilirubin < or = to 1.5 times the upper limit of normal (x uln); alanine transaminase (alt) and aspartate transaminase (ast) < or = to 1.5 x uln, (≤5 x uln, if liver involvement).
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0023884 (UMLS CUI [5,1])
C1314939 (UMLS CUI [5,2])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0023884 (UMLS CUI [5,1])
C1314939 (UMLS CUI [5,2])
Renal function | Creatinine measurement, serum
Item
renal: serum creatinine < or = to 1.5 x uln
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0201976 (UMLS CUI [2])
Bone Marrow Mature Neutrophils Present Adequate | Platelet Count measurement | Absolute neutrophil count | Exception Bone Marrow Involvement
Item
adequate bone marrow reserve: platelets > or = to 75 x 10 to the ninth/l, absolute neutrophil count (anc) > or = to 1.0 x 10 to the ninth/l, unless there is bone marrow involvement.
boolean
C0005953 (UMLS CUI [1,1])
C1708947 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,3])
C0032181 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0005953 (UMLS CUI [4,2])
C1314939 (UMLS CUI [4,3])
C1708947 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,3])
C0032181 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0005953 (UMLS CUI [4,2])
C1314939 (UMLS CUI [4,3])
Criteria Fulfill
Item
patients must not:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,2])
Drugs, Non-Prescription | Exception Enzastaurin
Item
6. have received treatment within the last 30 days with a drug (not including enzastaurin) that has not received regulatory approval for any indication at the time of study entry.
boolean
C0013231 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1327830 (UMLS CUI [2,2])
C1705847 (UMLS CUI [2,1])
C1327830 (UMLS CUI [2,2])
Cancer treatment Systemic
Item
7. are receiving concurrent administration of any other systemic anticancer therapy.
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
8. are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Lacking Able to swallow Tablets
Item
9. are unable to swallow tablets.
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,3])
C2712086 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,3])
Carbamazepine Discontinue Unable | Phenobarbital Discontinue Unable | Phenytoin Discontinue Unable
Item
10. are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin at least 14 days prior to study enrollment.
boolean
C0006949 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0031412 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0031507 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0031412 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0031507 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])