ID

28066

Beschrijving

Study of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00872976

Link

https://clinicaltrials.gov/show/NCT00872976

Trefwoorden

Versies (1)
  1. 14-12-17 14-12-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

14 december 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT00872976

Engels

Eligibility Chronic Lymphocytic Leukemia NCT00872976

1 Formulieren  
Criteria
Beschrijving

Criteria

diagnosis of b-cll by nci criteria
Beschrijving

Chronic Lymphocytic Leukemia

Datatype

boolean

Alias
UMLS CUI [1]
C0023434
require chemotherapy and have fully recovered from previous administered chemotherapy
Beschrijving

Chemotherapy Patient need for | Prior Chemotherapy Patient recovered

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0686904
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C1115804
subjects must have progressed, failed to achieve a meaningful response, or relapsed/intolerant to prior therapy. failing at least one purine analogue regimen
Beschrijving

Disease Progression | Response failed | Prior Therapy Recurrent disease | Prior Therapy intolerant | Purine analog Quantity failed

Datatype

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C0277556
UMLS CUI [4,1]
C1514463
UMLS CUI [4,2]
C0231200
UMLS CUI [5,1]
C1268902
UMLS CUI [5,2]
C1265611
UMLS CUI [5,3]
C0231175
subjects have received three or fewer prior treatment regimens
Beschrijving

Prior Therapy Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
ecog status of 0 - 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
inclusion criteria (cohort #2):
Beschrijving

Inclusion ceiteria Cohort Specified

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0599755
UMLS CUI [1,3]
C0205369
if dose level + 3 is reached, the criteria is the same as outlined for cohort #1, however the subjects should not have a history of prior chemotherapy (treatment naive)
Beschrijving

Dose level | Inclusion criteria Same | Prior Chemotherapy Absent | Therapy naive

Datatype

boolean

Alias
UMLS CUI [1]
C0178602
UMLS CUI [2,1]
C1512693
UMLS CUI [2,2]
C0445247
UMLS CUI [3,1]
C1514457
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0919936
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
unwilling or unable to use an acceptable method to avoid pregnancy
Beschrijving

Contraceptive methods Unwilling | Contraceptive methods Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C1299582
uncontrolled or significant cardiovascular disease, including prolonged qtc interval
Beschrijving

Cardiovascular Disease Uncontrolled | Cardiovascular Disease | Prolonged QTc interval

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0007222
UMLS CUI [3]
C1560305
history of significant bleeding disorder, unrelated to cll
Beschrijving

Blood Coagulation Disorder | CLL Relationship Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2,1]
C0023434
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0332197
prior concurrent malignancy
Beschrijving

Cancer Other

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
drugs that generally accepted to have the risk of causing torsades de pointes
Beschrijving

Pharmaceutical Preparations At risk Torsades de Pointes

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0040479
autoimmune hemolytic anemia requiring therapy or transfusion support
Beschrijving

Autoimmune hemolytic anemia Treatment required for | Autoimmune hemolytic anemia Requirement Support transfusion therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0002880
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0002880
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0436311
autoimmune thrombocytopenia requiring steroid therapy or transfusion support
Beschrijving

Autoimmune thrombocytopenia Requirement Steroid therapy | Autoimmune thrombocytopenia Requirement Support transfusion therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242584
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0149783
UMLS CUI [2,1]
C0242584
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0436311
richter's syndrome
Beschrijving

Richter's syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0349631
transformation to prolymphocytic leukemia
Beschrijving

Transformation Prolymphocytic Leukemia

Datatype

boolean

Alias
UMLS CUI [1,1]
C4055129
UMLS CUI [1,2]
C0023486
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00872976

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Chronic Lymphocytic Leukemia
Item
diagnosis of b-cll by nci criteria
boolean
C0023434 (UMLS CUI [1])
Chemotherapy Patient need for | Prior Chemotherapy Patient recovered
Item
require chemotherapy and have fully recovered from previous administered chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C1115804 (UMLS CUI [2,2])
Disease Progression | Response failed | Prior Therapy Recurrent disease | Prior Therapy intolerant | Purine analog Quantity failed
Item
subjects must have progressed, failed to achieve a meaningful response, or relapsed/intolerant to prior therapy. failing at least one purine analogue regimen
boolean
C0242656 (UMLS CUI [1])
C1704632 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C0277556 (UMLS CUI [3,2])
C1514463 (UMLS CUI [4,1])
C0231200 (UMLS CUI [4,2])
C1268902 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0231175 (UMLS CUI [5,3])
Prior Therapy Quantity
Item
subjects have received three or fewer prior treatment regimens
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
ECOG performance status
Item
ecog status of 0 - 2
boolean
C1520224 (UMLS CUI [1])
Inclusion ceiteria Cohort Specified
Item
inclusion criteria (cohort #2):
boolean
C1512693 (UMLS CUI [1,1])
C0599755 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Dose level | Inclusion criteria Same | Prior Chemotherapy Absent | Therapy naive
Item
if dose level + 3 is reached, the criteria is the same as outlined for cohort #1, however the subjects should not have a history of prior chemotherapy (treatment naive)
boolean
C0178602 (UMLS CUI [1])
C1512693 (UMLS CUI [2,1])
C0445247 (UMLS CUI [2,2])
C1514457 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0919936 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Contraceptive methods Unwilling | Contraceptive methods Unable
Item
unwilling or unable to use an acceptable method to avoid pregnancy
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease | Prolonged QTc interval
Item
uncontrolled or significant cardiovascular disease, including prolonged qtc interval
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
C1560305 (UMLS CUI [3])
Blood Coagulation Disorder | CLL Relationship Absent
Item
history of significant bleeding disorder, unrelated to cll
boolean
C0005779 (UMLS CUI [1])
C0023434 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Cancer Other
Item
prior concurrent malignancy
boolean
C1707251 (UMLS CUI [1])
Pharmaceutical Preparations At risk Torsades de Pointes
Item
drugs that generally accepted to have the risk of causing torsades de pointes
boolean
C0013227 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0040479 (UMLS CUI [1,3])
Autoimmune hemolytic anemia Treatment required for | Autoimmune hemolytic anemia Requirement Support transfusion therapy
Item
autoimmune hemolytic anemia requiring therapy or transfusion support
boolean
C0002880 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0002880 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0436311 (UMLS CUI [2,3])
Autoimmune thrombocytopenia Requirement Steroid therapy | Autoimmune thrombocytopenia Requirement Support transfusion therapy
Item
autoimmune thrombocytopenia requiring steroid therapy or transfusion support
boolean
C0242584 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0149783 (UMLS CUI [1,3])
C0242584 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0436311 (UMLS CUI [2,3])
Richter's syndrome
Item
richter's syndrome
boolean
C0349631 (UMLS CUI [1])
Transformation Prolymphocytic Leukemia
Item
transformation to prolymphocytic leukemia
boolean
C4055129 (UMLS CUI [1,1])
C0023486 (UMLS CUI [1,2])
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