ID

41219

Description

A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.; ODM derived from: https://clinicaltrials.gov/show/NCT01144403

Link

https://clinicaltrials.gov/show/NCT01144403

Keywords

Versions (1)
  1. 7/18/20 7/18/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 18, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoma, B-Cell NCT01144403

English

Eligibility Lymphoma, B-Cell NCT01144403

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/=18 years of age
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
untreated mantle cell lymphoma, not eligible for autologous stem cell transplantation
Description

Mantle cell lymphoma Untreated | Ineligibility Autologous hematopoietic stem cell transplant

Data type

boolean

Alias
UMLS CUI [1,1]
C0334634
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1512714
UMLS CUI [2,2]
C2193200
known mantle cell lymphoma international prognostic index (mipi) at diagnosis
Description

MIPI - Mantle Cell Lymphoma International Prognostic Index

Data type

boolean

Alias
UMLS CUI [1]
C4706335
ecog performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematological, renal and hepatic function
Description

Hematologic function | Renal function | Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hypersensitivity to murine proteins or chemotherapy regimen
Description

Hypersensitivity Murine protein | Hypersensitivity Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1699668
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0392920
previous first-line therapy
Description

First line treatment Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0205156
history of other malignancy within the last 5 years, except for squamous cell carcinoma, basal cell carcinoma of the skin or in situ cervical carcinoma
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007137
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
active infection
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
clinically significant cardiac disease
Description

Heart Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
regular corticosteroid treatment in the 4 weeks prior to first dose of study drug
Description

Steroid therapy Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0205272
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Similar models

Eligibility Lymphoma, B-Cell NCT01144403

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/=18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Mantle cell lymphoma Untreated | Ineligibility Autologous hematopoietic stem cell transplant
Item
untreated mantle cell lymphoma, not eligible for autologous stem cell transplantation
boolean
C0334634 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1512714 (UMLS CUI [2,1])
C2193200 (UMLS CUI [2,2])
MIPI - Mantle Cell Lymphoma International Prognostic Index
Item
known mantle cell lymphoma international prognostic index (mipi) at diagnosis
boolean
C4706335 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Renal function | Liver function
Item
adequate hematological, renal and hepatic function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Murine protein | Hypersensitivity Chemotherapy
Item
known hypersensitivity to murine proteins or chemotherapy regimen
boolean
C0020517 (UMLS CUI [1,1])
C1699668 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
First line treatment Previous
Item
previous first-line therapy
boolean
C1708063 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Cancer Other | Exception Squamous cell carcinoma | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
history of other malignancy within the last 5 years, except for squamous cell carcinoma, basal cell carcinoma of the skin or in situ cervical carcinoma
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007137 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Heart Disease
Item
clinically significant cardiac disease
boolean
C0018799 (UMLS CUI [1])
Steroid therapy Regular
Item
regular corticosteroid treatment in the 4 weeks prior to first dose of study drug
boolean
C0149783 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
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