ID

21430

Description

Fludarabine and Cyclophosphamide With or Without Rituximab in Treating Patients With Previously Untreated Mantle Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00641095

Link

https://clinicaltrials.gov/show/NCT00641095

Keywords

Versions (1)
  1. 4/21/17 4/21/17 -
Uploaded on

April 21, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00641095

English

Eligibility Lymphoma NCT00641095

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00641095
Criteria
Description

Criteria

histologically confirmed mantle cell lymphoma (mcl), meeting the following criteria:
Description

Mantle cell lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0334634
diagnosis confirmed by examination of representative material (lymph nodes or bone marrow) together with a typical immunophenotype cd5+, cd23-, sigm, cyclin d1 nuclear positivity is desirable but not essential
Description

Examination of lymph nodes or bone marrow and immunophenotype

Data type

boolean

Alias
UMLS CUI [1]
C0024204
UMLS CUI [2]
C1550653
UMLS CUI [3]
C0079611
central review of histology will be performed on diagnostic material
Description

Histological finding

Data type

boolean

Alias
UMLS CUI [1]
C0449575
molecular or cytogenetic confirmation of diagnosis is not required
Description

Molecular or cytogenetic confirmation

Data type

boolean

Alias
UMLS CUI [1]
C1513388
UMLS CUI [2]
C0010802
previously untreated disease at any stage requiring therapy in the opinion of the treating physician
Description

Untreated disease requiring therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0332155
UMLS CUI [1,2]
C1830593
patient characteristics:
Description

Patient characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
life expectancy ≥ 3 months
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
life expectancy not severely limited by other illness
Description

Comorbidity affecting life expectancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0023671
creatinine clearance ≥ 30 ml/min
Description

Creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0373595
not pregnant or nursing
Description

Gynaecological status

Data type

boolean

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

Pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032976
fertile patients must use effective contraception during study therapy
Description

Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
no known serological positivity for hbv, hcv, or hiv
Description

HBV, HCV, HIV serology

Data type

boolean

Alias
UMLS CUI [1]
C0744837
UMLS CUI [2]
C0850489
UMLS CUI [3]
C0019699
no concurrent uncontrolled serious medical conditions
Description

Uncontrolled comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0205318
UMLS CUI [1,2]
C0009488
no severe impairment of renal or liver function (alkaline phosphatase, bilirubin or creatinine > 2.5 times upper limit of normal) not related to lymphoma
Description

Renal or liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
no known hypersensitivity to murine proteins
Description

Hypersensitivity to murine proteins

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1699668
no prior malignancy in the past 5 years, except for nonmelanoma skin tumor or curatively resected carcinoma in situ of the uterine cervix
Description

Prior malignancy

Data type

boolean

Alias
UMLS CUI [1]
C2735088
no history of a psychological illness or condition that, in the opinion of the investigator, may adversely affect compliance with study medication
Description

Compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
prior concurrent therapy:
Description

Concurrent therapy

Data type

boolean

Alias
UMLS CUI [1]
C0009429
no prior chemotherapy
Description

Prior chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
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Similar models

Eligibility Lymphoma NCT00641095

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00641095
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Mantle cell lymphoma
Item
histologically confirmed mantle cell lymphoma (mcl), meeting the following criteria:
boolean
C0334634 (UMLS CUI [1])
Examination of lymph nodes or bone marrow and immunophenotype
Item
diagnosis confirmed by examination of representative material (lymph nodes or bone marrow) together with a typical immunophenotype cd5+, cd23-, sigm, cyclin d1 nuclear positivity is desirable but not essential
boolean
C0024204 (UMLS CUI [1])
C1550653 (UMLS CUI [2])
C0079611 (UMLS CUI [3])
Histological finding
Item
central review of histology will be performed on diagnostic material
boolean
C0449575 (UMLS CUI [1])
Molecular or cytogenetic confirmation
Item
molecular or cytogenetic confirmation of diagnosis is not required
boolean
C1513388 (UMLS CUI [1])
C0010802 (UMLS CUI [2])
Untreated disease requiring therapy
Item
previously untreated disease at any stage requiring therapy in the opinion of the treating physician
boolean
C0332155 (UMLS CUI [1,1])
C1830593 (UMLS CUI [1,2])
Patient characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Life expectancy
Item
life expectancy ≥ 3 months
boolean
C0023671 (UMLS CUI [1])
Comorbidity affecting life expectancy
Item
life expectancy not severely limited by other illness
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
Creatinine clearance
Item
creatinine clearance ≥ 30 ml/min
boolean
C0373595 (UMLS CUI [1])
Gynaecological status
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pregnancy test
Item
negative pregnancy test
boolean
C0032976 (UMLS CUI [1])
Contraceptive methods
Item
fertile patients must use effective contraception during study therapy
boolean
C0700589 (UMLS CUI [1])
HBV, HCV, HIV serology
Item
no known serological positivity for hbv, hcv, or hiv
boolean
C0744837 (UMLS CUI [1])
C0850489 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Uncontrolled comorbidity
Item
no concurrent uncontrolled serious medical conditions
boolean
C0205318 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Renal or liver function
Item
no severe impairment of renal or liver function (alkaline phosphatase, bilirubin or creatinine > 2.5 times upper limit of normal) not related to lymphoma
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Hypersensitivity to murine proteins
Item
no known hypersensitivity to murine proteins
boolean
C0020517 (UMLS CUI [1,1])
C1699668 (UMLS CUI [1,2])
Prior malignancy
Item
no prior malignancy in the past 5 years, except for nonmelanoma skin tumor or curatively resected carcinoma in situ of the uterine cervix
boolean
C2735088 (UMLS CUI [1])
Compliance
Item
no history of a psychological illness or condition that, in the opinion of the investigator, may adversely affect compliance with study medication
boolean
C1321605 (UMLS CUI [1])
Concurrent therapy
Item
prior concurrent therapy:
boolean
C0009429 (UMLS CUI [1])
Prior chemotherapy
Item
no prior chemotherapy
boolean
C1514457 (UMLS CUI [1])
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