ID

24569

Descripción

Combination Chemotherapy, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Newly Diagnosed Large B-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00690560

Link

https://clinicaltrials.gov/show/NCT00690560

Palabras clave

Versiones (1)
  1. 6/8/17 6/8/17 -
Subido en

6 de agosto de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00690560

Inglés

Eligibility Lymphoma NCT00690560

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00690560
Criteria
Descripción

Criteria

histologically confirmed large b-cell lymphoma
Descripción

Large B-Cell Lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079744
stage i, ii, iii, or iv disease
Descripción

Disease Ann Arbor lymphoma staging system

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0432516
bone marrow or lymph node involvement by small cell lymphoma allowed
Descripción

Bone Marrow Involvement Small Cell Lymphoma | Lymph Node Involvement Small Cell Lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1517677
UMLS CUI [1,2]
C0024303
UMLS CUI [2,1]
C0806692
UMLS CUI [2,2]
C0024303
no serious, progressive pathology (at investigator's discretion)
Descripción

Pathology Serious Progressive Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0677042
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205329
UMLS CUI [1,4]
C0332197
cd20-positive disease
Descripción

Disease CD20 antigen positive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3888518
measurable disease
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
no prior indolent lymphoma, treated or not
Descripción

Indolent lymphoma Treated Absent | Indolent lymphoma Untreated Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1334170
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1334170
UMLS CUI [2,2]
C0332155
UMLS CUI [2,3]
C0332197
no meningeal or cns lymphoma
Descripción

Meningeal Lymphoma Absent | Central nervous system lymphoma Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2213017
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0742472
UMLS CUI [2,2]
C0332197
patient characteristics:
Descripción

Client Characteristics

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0815172
international prognostic index < 2 (adjusted for age)
Descripción

International Prognostic Index Age adjusted

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512894
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C0456081
life expectancy > 3 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
alt and ast ≤ 2.5 times upper limit of normal
Descripción

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
bilirubin ≤ 30 mmol/l
Descripción

Serum total bilirubin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
creatinine ≤ 150 μmol/l
Descripción

Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
hiv, hepatitis b virus, and hepatitis c virus negative (unless after vaccine)
Descripción

HIV negative | Hepatitis B test negative | Hepatitis C test negative | Status post Vaccine Excluded

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0481430
UMLS CUI [2]
C1611173
UMLS CUI [3]
C1619717
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0042210
UMLS CUI [4,3]
C2828389
no contraindication to chemotherapy or immunotherapy
Descripción

Exclusion Criteria | Medical contraindication Chemotherapy | Medical contraindication Immunotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0392920
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0021083
no cancer in the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
Descripción

Malignant Neoplasms Exclusion | Basal cell carcinoma | Carcinoma in situ of uterine cervix

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C2828389
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0851140
no contraindication to a venous catheter
Descripción

Exclusion Criteria | Medical contraindication Intravenous Catheters

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0745442
prior concurrent therapy:
Descripción

Therapeutic procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Descripción

ID.20

Tipo de datos

boolean

at least 30 days since prior and no other concurrent investigational treatment
Descripción

Investigational Therapy Excluded

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0949266
UMLS CUI [1,2]
C2828389
no prior therapy
Descripción

Prior Therapy Excluded

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C2828389
no concurrent participation in another clinical study
Descripción

Exclusion Participation Clinical Trial Other

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0205394
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Similar models

Eligibility Lymphoma NCT00690560

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00690560
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Large B-Cell Lymphoma
Item
histologically confirmed large b-cell lymphoma
boolean
C0079744 (UMLS CUI [1])
Disease Ann Arbor lymphoma staging system
Item
stage i, ii, iii, or iv disease
boolean
C0012634 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
Bone Marrow Involvement Small Cell Lymphoma | Lymph Node Involvement Small Cell Lymphoma
Item
bone marrow or lymph node involvement by small cell lymphoma allowed
boolean
C1517677 (UMLS CUI [1,1])
C0024303 (UMLS CUI [1,2])
C0806692 (UMLS CUI [2,1])
C0024303 (UMLS CUI [2,2])
Pathology Serious Progressive Absent
Item
no serious, progressive pathology (at investigator's discretion)
boolean
C0677042 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205329 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Disease CD20 antigen positive
Item
cd20-positive disease
boolean
C0012634 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
Indolent lymphoma Treated Absent | Indolent lymphoma Untreated Absent
Item
no prior indolent lymphoma, treated or not
boolean
C1334170 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1334170 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Meningeal Lymphoma Absent | Central nervous system lymphoma Absent
Item
no meningeal or cns lymphoma
boolean
C2213017 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0742472 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
International Prognostic Index Age adjusted
Item
international prognostic index < 2 (adjusted for age)
boolean
C1512894 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0456081 (UMLS CUI [1,3])
Life Expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
alt and ast ≤ 2.5 times upper limit of normal
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Serum total bilirubin measurement
Item
bilirubin ≤ 30 mmol/l
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine ≤ 150 μmol/l
boolean
C0201976 (UMLS CUI [1])
HIV negative | Hepatitis B test negative | Hepatitis C test negative | Status post Vaccine Excluded
Item
hiv, hepatitis b virus, and hepatitis c virus negative (unless after vaccine)
boolean
C0481430 (UMLS CUI [1])
C1611173 (UMLS CUI [2])
C1619717 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C0042210 (UMLS CUI [4,2])
C2828389 (UMLS CUI [4,3])
Exclusion Criteria | Medical contraindication Chemotherapy | Medical contraindication Immunotherapy
Item
no contraindication to chemotherapy or immunotherapy
boolean
C0680251 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0021083 (UMLS CUI [3,2])
Malignant Neoplasms Exclusion | Basal cell carcinoma | Carcinoma in situ of uterine cervix
Item
no cancer in the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
boolean
C0006826 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0007117 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
Exclusion Criteria | Medical contraindication Intravenous Catheters
Item
no contraindication to a venous catheter
boolean
C0680251 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0745442 (UMLS CUI [2,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.20
Item
see disease characteristics
boolean
Investigational Therapy Excluded
Item
at least 30 days since prior and no other concurrent investigational treatment
boolean
C0949266 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Prior Therapy Excluded
Item
no prior therapy
boolean
C1514463 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Exclusion Participation Clinical Trial Other
Item
no concurrent participation in another clinical study
boolean
C2828389 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
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