ID

21430

Descripción

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

Palabras clave

Versiones (1)
  1. 21/4/17 21/4/17 -
Subido en

21 de abril de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Lymphoma NCT00641095

Inglés

Eligibility Lymphoma NCT00641095

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00641095
Criteria
Descripción

Criteria

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

Mantle cell lymphoma

Tipo de datos

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
Descripción

Examination of lymph nodes or bone marrow and immunophenotype

Tipo de datos

boolean

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

Histological finding

Tipo de datos

boolean

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

Molecular or cytogenetic confirmation

Tipo de datos

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
Descripción

Untreated disease requiring therapy

Tipo de datos

boolean

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

Patient characteristics

Tipo de datos

boolean

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

Life expectancy

Tipo de datos

boolean

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

Comorbidity affecting life expectancy

Tipo de datos

boolean

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

Creatinine clearance

Tipo de datos

boolean

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

Gynaecological status

Tipo de datos

boolean

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

Pregnancy test

Tipo de datos

boolean

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

Contraceptive methods

Tipo de datos

boolean

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

HBV, HCV, HIV serology

Tipo de datos

boolean

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

Uncontrolled comorbidity

Tipo de datos

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
Descripción

Renal or liver function

Tipo de datos

boolean

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

Hypersensitivity to murine proteins

Tipo de datos

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
Descripción

Prior malignancy

Tipo de datos

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
Descripción

Compliance

Tipo de datos

boolean

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

Concurrent therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009429
no prior chemotherapy
Descripción

Prior chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514457
Volver a la parte superior de la página

Similar models

Eligibility Lymphoma NCT00641095

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00641095
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial