ID

19465

Beschreibung

Study of R-ACVBP Regimen Supported by Pegfilgrastim in High-Risk Diffuse Large B-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00169143

Link

https://clinicaltrials.gov/show/NCT00169143

Stichworte

Versionen (1)
  1. 04.01.17 04.01.17 -
Hochgeladen am

4. Januar 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Untreated CD20-Positive Large B-Cell Lymphoma NCT00169143

Englisch

Eligibility Untreated CD20-Positive Large B-Cell Lymphoma NCT00169143

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient with histologically proven cd20+ diffuse large b cell lymphoma (who classification).
Beschreibung

Diffuse Large B-Cell Lymphoma CD20 antigen positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C3888518
age >18 and < 61 years, eligible for transplant.
Beschreibung

Age | Transplantation eligibility

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0040732
UMLS CUI [2,2]
C1698001
patient not previously treated.
Beschreibung

Patient untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
with at least two prognostic factors of the aa-ipi.
Beschreibung

International Prognostic Index Age Adjusted | Prognostic Factor Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512894
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C0456081
UMLS CUI [2,1]
C1514474
UMLS CUI [2,2]
C1265611
with a minimum life expectancy of 3 months.
Beschreibung

Life Expectancy Minimum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C1524031
creatinin level ≤ 150mmol/l, total bilirubin level  30mmol/l and transaminases  2.5 maximum normal level, unless abnormalities are related to the lymphoma.
Beschreibung

Creatinine measurement, serum | Serum total bilirubin measurement | Transaminases increased | Abnormality Lymphoma Related

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0438717
UMLS CUI [4,1]
C1704258
UMLS CUI [4,2]
C0024299
UMLS CUI [4,3]
C0439849
neutrophils > 1.5 g/l and platelets > 100 g/l, unless if patient has a bone marrow infiltration.
Beschreibung

Absolute neutrophil count | Platelet Count measurement | Bone marrow infiltration

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C3854434
negative hiv, hbv and hcv serologies  4 weeks (except after vaccination).
Beschreibung

HIV test negative | Hepatitis B Virus Serology negative | Hepatitis C virus Serology negative | Vaccination

Datentyp

boolean

Alias
UMLS CUI [1]
C0854048
UMLS CUI [2,1]
C0019169
UMLS CUI [2,2]
C0919674
UMLS CUI [3,1]
C0220847
UMLS CUI [3,2]
C0919674
UMLS CUI [4]
C0042196
having previously signed a written informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any other histological type of lymphoma.
Beschreibung

Lymphoma Histologic type

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0449574
any history of treated or non-treated indolent lymphoma.
Beschreibung

Indolent lymphoma Treated | Indolent lymphoma untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1334170
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C1334170
UMLS CUI [2,2]
C0332155
central nervous system or meningeal involvement by lymphoma.
Beschreibung

Central Nervous System Involvement Lymphoma | Meningeal Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0024299
UMLS CUI [2]
C2213017
contra-indication to any drug contained in the chemotherapy regimens.
Beschreibung

Medical contraindication Antineoplastic Agents

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003392
any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
Beschreibung

Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0851140
any serious active disease (according to the investigator’s decision).
Beschreibung

Disease Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
Beschreibung

Investigational New Drugs | Chemotherapy cycle Ordinal number

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C0439080
pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception.
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Inadequate

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0205412
adult patient under tutelage.
Beschreibung

Patient adult Guardianship

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0001675
UMLS CUI [1,3]
C0870627
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Ähnliche Modelle

Eligibility Untreated CD20-Positive Large B-Cell Lymphoma NCT00169143

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diffuse Large B-Cell Lymphoma CD20 antigen positive
Item
patient with histologically proven cd20+ diffuse large b cell lymphoma (who classification).
boolean
C0079744 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
Age | Transplantation eligibility
Item
age >18 and < 61 years, eligible for transplant.
boolean
C0001779 (UMLS CUI [1])
C0040732 (UMLS CUI [2,1])
C1698001 (UMLS CUI [2,2])
Patient untreated
Item
patient not previously treated.
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
International Prognostic Index Age Adjusted | Prognostic Factor Quantity
Item
with at least two prognostic factors of the aa-ipi.
boolean
C1512894 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0456081 (UMLS CUI [1,3])
C1514474 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Life Expectancy Minimum
Item
with a minimum life expectancy of 3 months.
boolean
C0023671 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
Creatinine measurement, serum | Serum total bilirubin measurement | Transaminases increased | Abnormality Lymphoma Related
Item
creatinin level ≤ 150mmol/l, total bilirubin level  30mmol/l and transaminases  2.5 maximum normal level, unless abnormalities are related to the lymphoma.
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0438717 (UMLS CUI [3])
C1704258 (UMLS CUI [4,1])
C0024299 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
Absolute neutrophil count | Platelet Count measurement | Bone marrow infiltration
Item
neutrophils > 1.5 g/l and platelets > 100 g/l, unless if patient has a bone marrow infiltration.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C3854434 (UMLS CUI [3])
HIV test negative | Hepatitis B Virus Serology negative | Hepatitis C virus Serology negative | Vaccination
Item
negative hiv, hbv and hcv serologies  4 weeks (except after vaccination).
boolean
C0854048 (UMLS CUI [1])
C0019169 (UMLS CUI [2,1])
C0919674 (UMLS CUI [2,2])
C0220847 (UMLS CUI [3,1])
C0919674 (UMLS CUI [3,2])
C0042196 (UMLS CUI [4])
Informed Consent
Item
having previously signed a written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lymphoma Histologic type
Item
any other histological type of lymphoma.
boolean
C0024299 (UMLS CUI [1,1])
C0449574 (UMLS CUI [1,2])
Indolent lymphoma Treated | Indolent lymphoma untreated
Item
any history of treated or non-treated indolent lymphoma.
boolean
C1334170 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1334170 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Central Nervous System Involvement Lymphoma | Meningeal Lymphoma
Item
central nervous system or meningeal involvement by lymphoma.
boolean
C4050309 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
C2213017 (UMLS CUI [2])
Medical contraindication Antineoplastic Agents
Item
contra-indication to any drug contained in the chemotherapy regimens.
boolean
C1301624 (UMLS CUI [1,1])
C0003392 (UMLS CUI [1,2])
Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix
Item
any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
Disease Serious
Item
any serious active disease (according to the investigator’s decision).
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Investigational New Drugs | Chemotherapy cycle Ordinal number
Item
treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
boolean
C0013230 (UMLS CUI [1])
C1302181 (UMLS CUI [2,1])
C0439080 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Inadequate
Item
pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0205412 (UMLS CUI [3,3])
Patient adult Guardianship
Item
adult patient under tutelage.
boolean
C0030705 (UMLS CUI [1,1])
C0001675 (UMLS CUI [1,2])
C0870627 (UMLS CUI [1,3])
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