ID

30395

Description

Se-Methyl-Seleno-L-Cysteine, Rituximab, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Diffuse Large B-Cell Lymphoma That Has Relapsed or Not Responded to Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00829205

Link

https://clinicaltrials.gov/show/NCT00829205

Keywords

Versions (1)
  1. 6/2/18 6/2/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 2, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00829205

English

Eligibility Lymphoma NCT00829205

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00829205
Criteria
Description

Criteria

histologically confirmed, cd20+, diffuse large b-cell lymphoma (dlbcl) according to who lymphoma classification
Description

Diffuse Large B-Cell Lymphoma CD20 positive WHO tumor classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C0882818
UMLS CUI [1,3]
C1301142
histological transformation of a previously known indolent lymphoma allowed
Description

Indolent Lymphoma Transformation

Data type

boolean

Alias
UMLS CUI [1,1]
C1334170
UMLS CUI [1,2]
C1536010
biopsy-proven dlbcl arising from an indolent lymphoma not diagnosed previously allowed
Description

Diffuse Large B-Cell Lymphoma Origin Indolent Lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C1334170
disease in first relapse after complete remission, partial response (pr), or less than a pr after first-line of treatment
Description

First Relapse Post Complete remission | Partial response | Less Than Partial response Post First line treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C4054953
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0677874
UMLS CUI [2]
C1521726
UMLS CUI [3,1]
C0439092
UMLS CUI [3,2]
C1521726
UMLS CUI [3,3]
C0687676
UMLS CUI [3,4]
C1708063
no primary cns lymphoma
Description

Primary central nervous system lymphoma Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0280803
UMLS CUI [1,2]
C0332197
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
ecog performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy > 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
serum creatinine < 150 μmol/l
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
serum bilirubin < 35 μmol/l
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
transaminases < 2.5 times upper limit of normal (unless attributed to lymphoma)
Description

Transaminase Assay | Exception Relationship Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0919834
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0024299
not pregnant or nursing
Description

Pregnancy Absent | Breast Feeding Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
negative pregnancy test
Description

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use effective contraception
Description

Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no contraindication to any of the drugs contained in the immunochemotherapy regimen
Description

Exclusion | Medical contraindication Pharmaceutical Preparations Immunochemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C4087148
no other malignancy within the past 2 years, except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
Description

Exclusion Cancer Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
no other serious active disease that, in the opinion of the investigator, would preclude the patient from having conventional chemotherapy
Description

Exclusion | Disease Serious Preventing Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0392920
no hiv positivity
Description

Exclusion HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0019699
no medical or psychiatric conditions that compromise the patient's ability to give informed consent
Description

Exclusion Criteria | Medical condition compromises Informed Consent | Mental condition compromises Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C0021430
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
not specified
Description

Unspecified

Data type

boolean

Alias
UMLS CUI [1]
C0205370
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Similar models

Eligibility Lymphoma NCT00829205

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00829205
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Diffuse Large B-Cell Lymphoma CD20 positive WHO tumor classification
Item
histologically confirmed, cd20+, diffuse large b-cell lymphoma (dlbcl) according to who lymphoma classification
boolean
C0079744 (UMLS CUI [1,1])
C0882818 (UMLS CUI [1,2])
C1301142 (UMLS CUI [1,3])
Indolent Lymphoma Transformation
Item
histological transformation of a previously known indolent lymphoma allowed
boolean
C1334170 (UMLS CUI [1,1])
C1536010 (UMLS CUI [1,2])
Diffuse Large B-Cell Lymphoma Origin Indolent Lymphoma
Item
biopsy-proven dlbcl arising from an indolent lymphoma not diagnosed previously allowed
boolean
C0079744 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C1334170 (UMLS CUI [1,3])
First Relapse Post Complete remission | Partial response | Less Than Partial response Post First line treatment
Item
disease in first relapse after complete remission, partial response (pr), or less than a pr after first-line of treatment
boolean
C4054953 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0677874 (UMLS CUI [1,3])
C1521726 (UMLS CUI [2])
C0439092 (UMLS CUI [3,1])
C1521726 (UMLS CUI [3,2])
C0687676 (UMLS CUI [3,3])
C1708063 (UMLS CUI [3,4])
Primary central nervous system lymphoma Absent
Item
no primary cns lymphoma
boolean
C0280803 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine < 150 μmol/l
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement
Item
serum bilirubin < 35 μmol/l
boolean
C1278039 (UMLS CUI [1])
Transaminase Assay | Exception Relationship Lymphoma
Item
transaminases < 2.5 times upper limit of normal (unless attributed to lymphoma)
boolean
C0919834 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0024299 (UMLS CUI [2,3])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Exclusion | Medical contraindication Pharmaceutical Preparations Immunochemotherapy
Item
no contraindication to any of the drugs contained in the immunochemotherapy regimen
boolean
C2828389 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C4087148 (UMLS CUI [2,3])
Exclusion Cancer Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix
Item
no other malignancy within the past 2 years, except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
boolean
C2828389 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
Exclusion | Disease Serious Preventing Chemotherapy
Item
no other serious active disease that, in the opinion of the investigator, would preclude the patient from having conventional chemotherapy
boolean
C2828389 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0392920 (UMLS CUI [2,4])
Exclusion HIV Seropositivity
Item
no hiv positivity
boolean
C2828389 (UMLS CUI [1,1])
C0019699 (UMLS CUI [1,2])
Exclusion Criteria | Medical condition compromises Informed Consent | Mental condition compromises Informed Consent
Item
no medical or psychiatric conditions that compromise the patient's ability to give informed consent
boolean
C0680251 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Unspecified
Item
not specified
boolean
C0205370 (UMLS CUI [1])
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