ID

30411

Descrição

HuMax-CD20 i(Ofatumumab) n Follicular Lymphoma (FL) Patients Refractory to Rituximab; ODM derived from: https://clinicaltrials.gov/show/NCT00394836

Link

https://clinicaltrials.gov/show/NCT00394836

Palavras-chave

Versões (2)
  1. 03/06/2018 03/06/2018 -
  2. 03/06/2018 03/06/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

3 de junho de 2018

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Lymphoma, Follicular NCT00394836

Inglês

Eligibility Lymphoma, Follicular NCT00394836

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient with follicular lymphoma grade 1 - 2
Descrição

Follicular Lymphoma Ann Arbor lymphoma staging system

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0432516
refractory to rituximab given as monotherapy or in combination with any chemotherapy or to rituximab given as maintenance treatment following r-chemo, defined as:
Descrição

Refractory Disease | rituximab | Chemotherapy | Maintenance therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514815
UMLS CUI [2]
C0393022
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0677908
failure to achieve at least pr to rituximab given as monotherapy or in combination with any chemotherapy; or,
Descrição

Partial response failed | rituximab | Chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1521726
UMLS CUI [1,2]
C0231175
UMLS CUI [2]
C0393022
UMLS CUI [3]
C0392920
disease progression while on rituximab (either given as monotherapy or in combination with any chemotherapy or during rituximab maintenance treatment following r-chemo); or,
Descrição

Disease Progression | rituximab | Chemotherapy | Maintenance therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0393022
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0677908
disease progression in responders within 6 months of the last dose of rituximab (either given as monotherapy or in combination with any chemotherapy or after rituximab maintenance treatment schedule following r-chemo)
Descrição

Disease Progression Therapy responder | rituximab | Chemotherapy | Maintenance therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0919876
UMLS CUI [2]
C0393022
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0677908
tumor verified to be cd20+ positive from excisional lymph node biopsy
Descrição

Tumor CD20 positive Excisional biopsy of lymph node

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0882818
UMLS CUI [1,3]
C0553989
ct scan in screening phase (based on local evaluation) showing:
Descrição

Evaluation Local CT scan

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0040405
2 or more clearly demarcated lesions with a largest diameter ≥ 1.5 cm, or
Descrição

Lesion Diameter Size Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0456389
UMLS CUI [1,4]
C1265611
1 clearly demarcated lesion with a largest diameter ≥ 2,0 cm
Descrição

Lesion Diameter Size Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0456389
UMLS CUI [1,4]
C1265611
ecog performance status of 0, 1, or 2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
age ≥ 18 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous autologous stem cell transplantation within 6 months
Descrição

Transplantation of autologous hematopoietic stem cell

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1831743
previous allogeneic stem cell transplantation
Descrição

Allogeneic Stem Cell Transplantation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2242529
more than 1 previous radio immunotherapy regimen
Descrição

Radioimmunotherapy Previous Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0085101
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C1265611
received radio immunotherapy within 3 months
Descrição

Radioimmunotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085101
received any anti-cancer treatment within 4 weeks
Descrição

Cancer treatment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0920425
received monoclonal antibodies, other than rituximab within 3 months
Descrição

Monoclonal Antibodies | Exception Rituximab

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003250
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0393022
patients previously treated with anti-cd20 monoclonal antibodies, other than rituximab
Descrição

Anti-CD20 Antibody | Exception Rituximab

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3891557
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0393022
life expectancy less than 6 months
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
Voltar ao início da página

Similar models

Eligibility Lymphoma, Follicular NCT00394836

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Follicular Lymphoma Ann Arbor lymphoma staging system
Item
patient with follicular lymphoma grade 1 - 2
boolean
C0024301 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
Refractory Disease | rituximab | Chemotherapy | Maintenance therapy
Item
refractory to rituximab given as monotherapy or in combination with any chemotherapy or to rituximab given as maintenance treatment following r-chemo, defined as:
boolean
C1514815 (UMLS CUI [1])
C0393022 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0677908 (UMLS CUI [4])
Partial response failed | rituximab | Chemotherapy
Item
failure to achieve at least pr to rituximab given as monotherapy or in combination with any chemotherapy; or,
boolean
C1521726 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0393022 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
Disease Progression | rituximab | Chemotherapy | Maintenance therapy
Item
disease progression while on rituximab (either given as monotherapy or in combination with any chemotherapy or during rituximab maintenance treatment following r-chemo); or,
boolean
C0242656 (UMLS CUI [1])
C0393022 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0677908 (UMLS CUI [4])
Disease Progression Therapy responder | rituximab | Chemotherapy | Maintenance therapy
Item
disease progression in responders within 6 months of the last dose of rituximab (either given as monotherapy or in combination with any chemotherapy or after rituximab maintenance treatment schedule following r-chemo)
boolean
C0242656 (UMLS CUI [1,1])
C0919876 (UMLS CUI [1,2])
C0393022 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0677908 (UMLS CUI [4])
Tumor CD20 positive Excisional biopsy of lymph node
Item
tumor verified to be cd20+ positive from excisional lymph node biopsy
boolean
C0027651 (UMLS CUI [1,1])
C0882818 (UMLS CUI [1,2])
C0553989 (UMLS CUI [1,3])
Evaluation Local CT scan
Item
ct scan in screening phase (based on local evaluation) showing:
boolean
C1261322 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
Lesion Diameter Size Quantity
Item
2 or more clearly demarcated lesions with a largest diameter ≥ 1.5 cm, or
boolean
C0221198 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Lesion Diameter Size Quantity
Item
1 clearly demarcated lesion with a largest diameter ≥ 2,0 cm
boolean
C0221198 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
ECOG performance status
Item
ecog performance status of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Transplantation of autologous hematopoietic stem cell
Item
previous autologous stem cell transplantation within 6 months
boolean
C1831743 (UMLS CUI [1])
Allogeneic Stem Cell Transplantation
Item
previous allogeneic stem cell transplantation
boolean
C2242529 (UMLS CUI [1])
Radioimmunotherapy Previous Quantity
Item
more than 1 previous radio immunotherapy regimen
boolean
C0085101 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Radioimmunotherapy
Item
received radio immunotherapy within 3 months
boolean
C0085101 (UMLS CUI [1])
Cancer treatment
Item
received any anti-cancer treatment within 4 weeks
boolean
C0920425 (UMLS CUI [1])
Monoclonal Antibodies | Exception Rituximab
Item
received monoclonal antibodies, other than rituximab within 3 months
boolean
C0003250 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0393022 (UMLS CUI [2,2])
Anti-CD20 Antibody | Exception Rituximab
Item
patients previously treated with anti-cd20 monoclonal antibodies, other than rituximab
boolean
C3891557 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0393022 (UMLS CUI [2,2])
Life Expectancy
Item
life expectancy less than 6 months
boolean
C0023671 (UMLS CUI [1])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

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