ID

43879

Beskrivning

A Pilot Study of Standard-Dose Rituximab, Ifosfamide, Carboplatin and Etoposide (RICE) Plus Bortezomib (Velcade) in a Dose-Escalating Fashion for Patients With Relapsed or Primary Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma Who Are Candidates for Autologous Stem Cell Transplant; ODM derived from: https://clinicaltrials.gov/show/NCT00515138

Länk

https://clinicaltrials.gov/show/NCT00515138

Nyckelord

Versioner (2)
  1. 29.06.17 29.06.17 -
  2. 20.09.21 20.09.21 -
Uppladdad den

20. September 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Lymphoma, B-Cell NCT00515138

Engelsk

Eligibility Lymphoma, B-Cell NCT00515138

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
aggressive b-cell lymphoma, cd-20 positive, in first relapse or refractory to first-line chemotherapy
Beskrivning

ID.1

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0855090
UMLS CUI [1,2]
C3888518
UMLS CUI [1,3]
C0392920
diffuse large b-cell lymphoma, mantle cell lymphoma, follicular lymphoma (grade iii), transformed follicular lymphoma
Beskrivning

ID.2

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C0677725
UMLS CUI [1,3]
C0024301
rituximab is allowed
Beskrivning

ID.3

Datatyp

boolean

Alias
UMLS CUI [1]
C0393022
prior radiation is allowed
Beskrivning

ID.4

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
18-70 years of age
Beskrivning

ID.5

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0-2
Beskrivning

ID.6

Datatyp

boolean

Alias
UMLS CUI [1]
C3541269
hiv seronegative
Beskrivning

ID.7

Datatyp

boolean

Alias
UMLS CUI [1]
C0019698
measurable disease on ct scan by international working group response criteria
Beskrivning

ID.8

Datatyp

boolean

Alias
UMLS CUI [1]
C0040405
no cns involvement
Beskrivning

ID.9

Datatyp

boolean

Alias
UMLS CUI [1]
C3714787
subject is considered to be a candidate for autologous stem cell transplant in the opinion of the treating physician
Beskrivning

ID.10

Datatyp

boolean

Alias
UMLS CUI [1]
C2193200
female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control
Beskrivning

ID.11

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009862
UMLS CUI [1,2]
C0232970
male subject agrees to use an acceptable method of contraception for the duration of the study
Beskrivning

ID.12

Datatyp

boolean

Alias
UMLS CUI [1]
C0009862
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
platelet count of <75 x 10(9)/l
Beskrivning

ID.13

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
absolute neutrophil count of <1.0 x 10(9)/l
Beskrivning

ID.14

Datatyp

boolean

Alias
UMLS CUI [1]
C0151683
calculated or measured creatinine clearance of <60 ml/minute within 14 days before enrollment
Beskrivning

ID.15

Datatyp

boolean

Alias
UMLS CUI [1]
C0373595
myocardial infarction within 6 months prior to enrollment or has new york hospital association class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. prior to study entry, any ecg abnormality at screening has to be documented by the investigator as not medically relevant.
Beskrivning

ID.16

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
subject has hypersensitivity to bortezomib, boron or mannitol.
Beskrivning

ID.17

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1176309
UMLS CUI [1,2]
C0006030
UMLS CUI [1,3]
C0024730
UMLS CUI [1,4]
C0020517
female subject is pregnant or breast-feeding.
Beskrivning

ID.18

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
subject has been treated with more than one prior chemotherapy regimen.
Beskrivning

ID.19

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
subject has received other investigational drugs with 14 days before enrollment.
Beskrivning

ID.20

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Beskrivning

ID.21

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0012634
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Similar models

Eligibility Lymphoma, B-Cell NCT00515138

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
aggressive b-cell lymphoma, cd-20 positive, in first relapse or refractory to first-line chemotherapy
boolean
C0855090 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
ID.2
Item
diffuse large b-cell lymphoma, mantle cell lymphoma, follicular lymphoma (grade iii), transformed follicular lymphoma
boolean
C0079744 (UMLS CUI [1,1])
C0677725 (UMLS CUI [1,2])
C0024301 (UMLS CUI [1,3])
ID.3
Item
rituximab is allowed
boolean
C0393022 (UMLS CUI [1])
ID.4
Item
prior radiation is allowed
boolean
C1522449 (UMLS CUI [1])
ID.5
Item
18-70 years of age
boolean
C0001779 (UMLS CUI [1])
ID.6
Item
ecog performance status of 0-2
boolean
C3541269 (UMLS CUI [1])
ID.7
Item
hiv seronegative
boolean
C0019698 (UMLS CUI [1])
ID.8
Item
measurable disease on ct scan by international working group response criteria
boolean
C0040405 (UMLS CUI [1])
ID.9
Item
no cns involvement
boolean
C3714787 (UMLS CUI [1])
ID.10
Item
subject is considered to be a candidate for autologous stem cell transplant in the opinion of the treating physician
boolean
C2193200 (UMLS CUI [1])
ID.11
Item
female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control
boolean
C0009862 (UMLS CUI [1,1])
C0232970 (UMLS CUI [1,2])
ID.12
Item
male subject agrees to use an acceptable method of contraception for the duration of the study
boolean
C0009862 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.13
Item
platelet count of <75 x 10(9)/l
boolean
C0032181 (UMLS CUI [1])
ID.14
Item
absolute neutrophil count of <1.0 x 10(9)/l
boolean
C0151683 (UMLS CUI [1])
ID.15
Item
calculated or measured creatinine clearance of <60 ml/minute within 14 days before enrollment
boolean
C0373595 (UMLS CUI [1])
ID.16
Item
myocardial infarction within 6 months prior to enrollment or has new york hospital association class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. prior to study entry, any ecg abnormality at screening has to be documented by the investigator as not medically relevant.
boolean
C0018799 (UMLS CUI [1])
ID.17
Item
subject has hypersensitivity to bortezomib, boron or mannitol.
boolean
C1176309 (UMLS CUI [1,1])
C0006030 (UMLS CUI [1,2])
C0024730 (UMLS CUI [1,3])
C0020517 (UMLS CUI [1,4])
ID.18
Item
female subject is pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
ID.19
Item
subject has been treated with more than one prior chemotherapy regimen.
boolean
C0392920 (UMLS CUI [1])
ID.20
Item
subject has received other investigational drugs with 14 days before enrollment.
boolean
C0013230 (UMLS CUI [1])
ID.21
Item
serious medical or psychiatric illness likely to interfere with participation in this clinical study.
boolean
C0004936 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
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