ID

30357

Beschreibung

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

Stichworte

Versionen (3)
  1. 29.05.18 29.05.18 -
  2. 29.05.18 29.05.18 -
  3. 29.05.18 29.05.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

29. Mai 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00451178

Englisch

Eligibility Lymphoma NCT00451178

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00451178
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must:
Beschreibung

Criteria Fulfill

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Prior Chemotherapy Absent

Datentyp

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.
Beschreibung

IPI

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

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

Organ function

Datentyp

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).
Beschreibung

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

Datentyp

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
Beschreibung

Renal function | Creatinine measurement, serum

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not:
Beschreibung

Criteria Fulfill

Datentyp

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.
Beschreibung

Drugs, Non-Prescription | Exception Enzastaurin

Datentyp

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.
Beschreibung

Cancer treatment Systemic

Datentyp

boolean

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

Pregnancy | Breast Feeding

Datentyp

boolean

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

Lacking Able to swallow Tablets

Datentyp

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.
Beschreibung

Carbamazepine Discontinue Unable | Phenobarbital Discontinue Unable | Phenytoin Discontinue Unable

Datentyp

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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Ähnliche Modelle

Eligibility Lymphoma NCT00451178

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00451178
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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