ID

30411

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00394836

Nyckelord

Versioner (2)
  1. 2018-06-03 2018-06-03 -
  2. 2018-06-03 2018-06-03 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

3 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Lymphoma, Follicular NCT00394836

Engelsk

Eligibility Lymphoma, Follicular NCT00394836

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Follicular Lymphoma Ann Arbor lymphoma staging system

Datatyp

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:
Beskrivning

Refractory Disease | rituximab | Chemotherapy | Maintenance therapy

Datatyp

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,
Beskrivning

Partial response failed | rituximab | Chemotherapy

Datatyp

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,
Beskrivning

Disease Progression | rituximab | Chemotherapy | Maintenance therapy

Datatyp

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)
Beskrivning

Disease Progression Therapy responder | rituximab | Chemotherapy | Maintenance therapy

Datatyp

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
Beskrivning

Tumor CD20 positive Excisional biopsy of lymph node

Datatyp

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:
Beskrivning

Evaluation Local CT scan

Datatyp

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
Beskrivning

Lesion Diameter Size Quantity

Datatyp

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
Beskrivning

Lesion Diameter Size Quantity

Datatyp

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
Beskrivning

ECOG performance status

Datatyp

boolean

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

Age

Datatyp

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
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Transplantation of autologous hematopoietic stem cell

Datatyp

boolean

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

Allogeneic Stem Cell Transplantation

Datatyp

boolean

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

Radioimmunotherapy Previous Quantity

Datatyp

boolean

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

Radioimmunotherapy

Datatyp

boolean

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

Cancer treatment

Datatyp

boolean

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

Monoclonal Antibodies | Exception Rituximab

Datatyp

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
Beskrivning

Anti-CD20 Antibody | Exception Rituximab

Datatyp

boolean

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

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibility Lymphoma, Follicular NCT00394836

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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