ID

24569

Beschreibung

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

Stichworte

Versionen (1)
  1. 06.08.17 06.08.17 -
Hochgeladen am

6. August 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00690560

Englisch

Eligibility Lymphoma NCT00690560

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00690560
Criteria
Beschreibung

Criteria

histologically confirmed large b-cell lymphoma
Beschreibung

Large B-Cell Lymphoma

Datentyp

boolean

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

Disease Ann Arbor lymphoma staging system

Datentyp

boolean

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

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

Datentyp

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)
Beschreibung

Pathology Serious Progressive Absent

Datentyp

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
Beschreibung

Disease CD20 antigen positive

Datentyp

boolean

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

Measurable Disease

Datentyp

boolean

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

Indolent lymphoma Treated Absent | Indolent lymphoma Untreated Absent

Datentyp

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
Beschreibung

Meningeal Lymphoma Absent | Central nervous system lymphoma Absent

Datentyp

boolean

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

Client Characteristics

Datentyp

boolean

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

International Prognostic Index Age adjusted

Datentyp

boolean

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

Life Expectancy

Datentyp

boolean

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

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datentyp

boolean

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

Serum total bilirubin measurement

Datentyp

boolean

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

Creatinine measurement, serum

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Exclusion Criteria | Medical contraindication Chemotherapy | Medical contraindication Immunotherapy

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria | Medical contraindication Intravenous Catheters

Datentyp

boolean

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

Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Beschreibung

ID.20

Datentyp

boolean

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

Investigational Therapy Excluded

Datentyp

boolean

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

Prior Therapy Excluded

Datentyp

boolean

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

Exclusion Participation Clinical Trial Other

Datentyp

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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Ähnliche Modelle

Eligibility Lymphoma NCT00690560

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00690560
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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