ID

35340

Description

Efficacy and Safety of Bendamustine Plus Rituximab in Chronic Lympocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02491398

Link

https://clinicaltrials.gov/show/NCT02491398

Keywords

Versions (1)
  1. 2/28/19 2/28/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 28, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT02491398

English

Eligibility Chronic Lymphocytic Leukemia NCT02491398

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of cll / small lymphocytic lymphoma (cll/) according to the world health organisation (who) classification 2008.
Description

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C1302547
patients who were treated with first and second-line bendamustine plus rituximab (br) from january 2008 to december 2014 from european centres adhering to the gimema group and the eric group.
Description

Bendamustine/rituximab First line treatment | Bendamustine/rituximab Second line treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1328232
UMLS CUI [1,2]
C1708063
UMLS CUI [2,1]
C1328232
UMLS CUI [2,2]
C1710038
previously untreated cll patients requiring therapy according to the nci criteria (hallek m et al, blood 2008 - appendix g) and treated with at least one cycle of br as first-line treatment.
Description

Prior Therapy Absent | Chronic Lymphocytic Leukemia Treatment required for | bendamustine/rituximab Course Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0023434
UMLS CUI [2,2]
C0332121
UMLS CUI [3,1]
C1328232
UMLS CUI [3,2]
C0750729
UMLS CUI [3,3]
C1265611
cll patients that received one previous line of treatment using alkylating agents and/or purine analogues with or without monoclonal antibodies, requiring second-line therapy according to the nci criteria (hallek m et al, blood 2008 - appendix g) and treated with at least one cycle of bendamustine and rituximab.
Description

Prior Therapy Chronic Lymphocytic Leukemia | Alkylating Agents | Purine analog | Monoclonal Antibodies | Monoclonal Antibodies Absent | Patient need for Second line treatment | bendamustine/rituximab Course Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0023434
UMLS CUI [2]
C0002073
UMLS CUI [3]
C1268902
UMLS CUI [4]
C0003250
UMLS CUI [5,1]
C0003250
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0686904
UMLS CUI [6,2]
C1710038
UMLS CUI [7,1]
C1328232
UMLS CUI [7,2]
C0750729
UMLS CUI [7,3]
C1265611
age ≥ 18 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
signed written informed consent according to ich/eu/gcp and national local law.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have received 2 or more lines of prior therapy.
Description

Prior Therapy Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
patients with:
Description

Patients Have

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3539897
transformation of cll into aggressive lymphomas (richter's syndrome). hiv infection. active and uncontrolled hcv and/or hbv infections or liver cirrhosis.
Description

Chronic lymphocytic leukaemia transformation Aggressive Lymphoma | Richter's syndrome | HIV Infection | Hepatitis C Uncontrolled | Hepatitis B Uncontrolled | Liver Cirrhosis Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C1142081
UMLS CUI [1,2]
C1332225
UMLS CUI [2]
C0349631
UMLS CUI [3]
C0019693
UMLS CUI [4,1]
C0019196
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C0019163
UMLS CUI [5,2]
C0205318
UMLS CUI [6,1]
C0023890
UMLS CUI [6,2]
C0205318
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT02491398

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Item
diagnosis of cll / small lymphocytic lymphoma (cll/) according to the world health organisation (who) classification 2008.
boolean
C1302547 (UMLS CUI [1])
Bendamustine/rituximab First line treatment | Bendamustine/rituximab Second line treatment
Item
patients who were treated with first and second-line bendamustine plus rituximab (br) from january 2008 to december 2014 from european centres adhering to the gimema group and the eric group.
boolean
C1328232 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C1328232 (UMLS CUI [2,1])
C1710038 (UMLS CUI [2,2])
Prior Therapy Absent | Chronic Lymphocytic Leukemia Treatment required for | bendamustine/rituximab Course Quantity
Item
previously untreated cll patients requiring therapy according to the nci criteria (hallek m et al, blood 2008 - appendix g) and treated with at least one cycle of br as first-line treatment.
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0023434 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C1328232 (UMLS CUI [3,1])
C0750729 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Prior Therapy Chronic Lymphocytic Leukemia | Alkylating Agents | Purine analog | Monoclonal Antibodies | Monoclonal Antibodies Absent | Patient need for Second line treatment | bendamustine/rituximab Course Quantity
Item
cll patients that received one previous line of treatment using alkylating agents and/or purine analogues with or without monoclonal antibodies, requiring second-line therapy according to the nci criteria (hallek m et al, blood 2008 - appendix g) and treated with at least one cycle of bendamustine and rituximab.
boolean
C1514463 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C0002073 (UMLS CUI [2])
C1268902 (UMLS CUI [3])
C0003250 (UMLS CUI [4])
C0003250 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0686904 (UMLS CUI [6,1])
C1710038 (UMLS CUI [6,2])
C1328232 (UMLS CUI [7,1])
C0750729 (UMLS CUI [7,2])
C1265611 (UMLS CUI [7,3])
Age
Item
age ≥ 18 years old.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
signed written informed consent according to ich/eu/gcp and national local law.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Quantity
Item
patients who have received 2 or more lines of prior therapy.
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Patients Have
Item
patients with:
boolean
C0030705 (UMLS CUI [1,1])
C3539897 (UMLS CUI [1,2])
Chronic lymphocytic leukaemia transformation Aggressive Lymphoma | Richter's syndrome | HIV Infection | Hepatitis C Uncontrolled | Hepatitis B Uncontrolled | Liver Cirrhosis Uncontrolled
Item
transformation of cll into aggressive lymphomas (richter's syndrome). hiv infection. active and uncontrolled hcv and/or hbv infections or liver cirrhosis.
boolean
C1142081 (UMLS CUI [1,1])
C1332225 (UMLS CUI [1,2])
C0349631 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C0019196 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0019163 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0023890 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
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