ID

30411

Description

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

Keywords

Versions (2)
  1. 6/3/18 6/3/18 -
  2. 6/3/18 6/3/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 3, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoma, Follicular NCT00394836

English

Eligibility Lymphoma, Follicular NCT00394836

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Follicular Lymphoma Ann Arbor lymphoma staging system

Data type

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:
Description

Refractory Disease | rituximab | Chemotherapy | Maintenance therapy

Data type

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,
Description

Partial response failed | rituximab | Chemotherapy

Data type

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,
Description

Disease Progression | rituximab | Chemotherapy | Maintenance therapy

Data type

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)
Description

Disease Progression Therapy responder | rituximab | Chemotherapy | Maintenance therapy

Data type

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
Description

Tumor CD20 positive Excisional biopsy of lymph node

Data type

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:
Description

Evaluation Local CT scan

Data type

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
Description

Lesion Diameter Size Quantity

Data type

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
Description

Lesion Diameter Size Quantity

Data type

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
Description

ECOG performance status

Data type

boolean

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

Age

Data type

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
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

Transplantation of autologous hematopoietic stem cell

Data type

boolean

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

Allogeneic Stem Cell Transplantation

Data type

boolean

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

Radioimmunotherapy Previous Quantity

Data type

boolean

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

Radioimmunotherapy

Data type

boolean

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

Cancer treatment

Data type

boolean

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

Monoclonal Antibodies | Exception Rituximab

Data type

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
Description

Anti-CD20 Antibody | Exception Rituximab

Data type

boolean

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

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibility Lymphoma, Follicular NCT00394836

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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