ID

30357

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00451178

Palabras clave

Versiones (3)
  1. 29/5/18 29/5/18 -
  2. 29/5/18 29/5/18 -
  3. 29/5/18 29/5/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

29 de mayo de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00451178

Inglés

Eligibility Lymphoma NCT00451178

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00451178
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must:
Descripción

Criteria Fulfill

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
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.
Descripción

Diffuse Large B-Cell Lymphoma WHO classification | Ineligibility Indolent lymphoma | Ineligibility Follicular Lymphoma Ann Arbor lymphoma staging system

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C4267671
UMLS CUI [2,1]
C1512714
UMLS CUI [2,2]
C1334170
UMLS CUI [3,1]
C1512714
UMLS CUI [3,2]
C0024301
UMLS CUI [3,3]
C0432516
2. have received no prior chemotherapy.
Descripción

Prior Chemotherapy Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
3. have an ipi score > or = to 2 at time of original diagnosis.
Descripción

IPI

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1512894
4. have a performance status of 0, 1, or 2 on the eastern cooperative oncology group (ecog) scale.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
5. have adequate organ function as follows:
Descripción

Organ function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678852
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).
Descripción

Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Liver Involvement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
UMLS CUI [5,1]
C0023884
UMLS CUI [5,2]
C1314939
renal: serum creatinine < or = to 1.5 x uln
Descripción

Renal function | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
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.
Descripción

Bone Marrow Mature Neutrophils Present Adequate | Platelet Count measurement | Absolute neutrophil count | Exception Bone Marrow Involvement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C1708947
UMLS CUI [1,3]
C0205411
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0948762
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0005953
UMLS CUI [4,3]
C1314939
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not:
Descripción

Criteria Fulfill

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
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.
Descripción

Drugs, Non-Prescription | Exception Enzastaurin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1327830
7. are receiving concurrent administration of any other systemic anticancer therapy.
Descripción

Cancer treatment Systemic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
8. are pregnant or breastfeeding.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
9. are unable to swallow tablets.
Descripción

Lacking Able to swallow Tablets

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0039225
10. are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin at least 14 days prior to study enrollment.
Descripción

Carbamazepine Discontinue Unable | Phenobarbital Discontinue Unable | Phenytoin Discontinue Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006949
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0031412
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0031507
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C1299582
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Similar models

Eligibility Lymphoma NCT00451178

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00451178
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
patients must:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Diffuse Large B-Cell Lymphoma WHO classification | Ineligibility Indolent lymphoma | Ineligibility Follicular Lymphoma Ann Arbor lymphoma staging system
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
C0079744 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
C1512714 (UMLS CUI [2,1])
C1334170 (UMLS CUI [2,2])
C1512714 (UMLS CUI [3,1])
C0024301 (UMLS CUI [3,2])
C0432516 (UMLS CUI [3,3])
Prior Chemotherapy Absent
Item
2. have received no prior chemotherapy.
boolean
C1514457 (UMLS CUI [1,1])
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])
Renal function | Creatinine measurement, serum
Item
renal: serum creatinine < or = to 1.5 x uln
boolean
C0232804 (UMLS CUI [1])
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])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
patients must not:
boolean
C0243161 (UMLS CUI [1,1])
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])
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])
Pregnancy | Breast Feeding
Item
8. are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
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])
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])
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