ID

21426

Beschrijving

Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL); ODM derived from: https://clinicaltrials.gov/show/NCT00289549

Link

https://clinicaltrials.gov/show/NCT00289549

Trefwoorden

Versies (1)
  1. 21-04-17 21-04-17 -
Geüploaded op

21 april 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Leukemia, Lymphocytic, Chronic NCT00289549

Engels

Eligibility Leukemia, Lymphocytic, Chronic NCT00289549

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
ages 18 years and older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of cll established by peripheral blood and bone marrow examination and using the standard criteria
Beschrijving

Chronic Lymphocytic Leukemia | Blood--Examination Peripheral | Bone Marrow Examination | Criteria Standard

Datatype

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2,1]
C3826648
UMLS CUI [2,2]
C0205100
UMLS CUI [3]
C0005957
UMLS CUI [4,1]
C0243161
UMLS CUI [4,2]
C1442989
patients with rai stage iii or iv, or earlier stage with massive, symptomatic lymphadenopathy requiring therapy
Beschrijving

Rai Staging System | Lymphadenopathy massive Symptomatic | Therapeutic procedure Patient need for

Datatype

boolean

Alias
UMLS CUI [1]
C1514715
UMLS CUI [2,1]
C0235599
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0686904
primary resistance to fludarabine-based therapy (no complete response [cr] or partial response [pr]) or progressive disease within 6 months of response to prior fludarabine containing regimen.
Beschrijving

Therapeutic procedure Fludarabine Based | Resistance Primary | Complete response Absent | Partial response Absent | Progressive Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0059985
UMLS CUI [1,3]
C1705938
UMLS CUI [2,1]
C1514892
UMLS CUI [2,2]
C0205225
UMLS CUI [3,1]
C0677874
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1521726
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C1335499
ecog performance status of 0, 1, 2 or 3
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
willing to take adequate contraception (i.e. latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after
Beschrijving

Contraceptive methods | Latex condom | CERVICAL CAP FOR CONTRACEPTIVE USE | Vaginal contraceptive diaphragm | Sexual Abstinence

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C3873750
UMLS CUI [3]
C0493327
UMLS CUI [4]
C0042241
UMLS CUI [5]
C0036899
all investigational treatments should have been discontinued for at least 1 week prior to the initiation of the study drug.
Beschrijving

Investigational Therapies Discontinued

Datatype

boolean

Alias
UMLS CUI [1,1]
C0949266
UMLS CUI [1,2]
C1444662
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or nursing
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
unable or unwilling to sign consent
Beschrijving

Informed Consent Unable | Informed Consent Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
severe, ongoing co-morbid conditions, which would preclude safe delivery of the investigational therapy
Beschrijving

Comorbidity Severe | Investigational Therapy Excluded

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C2828389
active serious infections that are not controlled by antibiotics
Beschrijving

Communicable Diseases Serious Uncontrolled | Antibiotics

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2]
C0003232
ecog performance status 4
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
inadequate renal function: creatinine 2.0 or more unless related to the disease
Beschrijving

Abnormal renal function | Creatinine measurement, serum | Serum creatinine measurement Disease Related

Datatype

boolean

Alias
UMLS CUI [1]
C0151746
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C0201976
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0439849
inadequate liver function: bilirubin 3.0 or more, transaminases 3 x upper limit of normal or more unless related to the disease
Beschrijving

Liver function abnormal | Serum total bilirubin measurement | Transaminases increased | Transaminases increased Disease Related

Datatype

boolean

Alias
UMLS CUI [1]
C0151766
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0438717
UMLS CUI [4,1]
C0438717
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C0439849
known positive test for hiv
Beschrijving

HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
patients with known hepatitis b and/or hepatitis c active infection
Beschrijving

Hepatitis B | Hepatitis C

Datatype

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
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Similar models

Eligibility Leukemia, Lymphocytic, Chronic NCT00289549

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
ages 18 years and older
boolean
C0001779 (UMLS CUI [1])
Chronic Lymphocytic Leukemia | Blood--Examination Peripheral | Bone Marrow Examination | Criteria Standard
Item
diagnosis of cll established by peripheral blood and bone marrow examination and using the standard criteria
boolean
C0023434 (UMLS CUI [1])
C3826648 (UMLS CUI [2,1])
C0205100 (UMLS CUI [2,2])
C0005957 (UMLS CUI [3])
C0243161 (UMLS CUI [4,1])
C1442989 (UMLS CUI [4,2])
Rai Staging System | Lymphadenopathy massive Symptomatic | Therapeutic procedure Patient need for
Item
patients with rai stage iii or iv, or earlier stage with massive, symptomatic lymphadenopathy requiring therapy
boolean
C1514715 (UMLS CUI [1])
C0235599 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
Therapeutic procedure Fludarabine Based | Resistance Primary | Complete response Absent | Partial response Absent | Progressive Disease
Item
primary resistance to fludarabine-based therapy (no complete response [cr] or partial response [pr]) or progressive disease within 6 months of response to prior fludarabine containing regimen.
boolean
C0087111 (UMLS CUI [1,1])
C0059985 (UMLS CUI [1,2])
C1705938 (UMLS CUI [1,3])
C1514892 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C0677874 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1521726 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1335499 (UMLS CUI [5])
ECOG performance status
Item
ecog performance status of 0, 1, 2 or 3
boolean
C1520224 (UMLS CUI [1])
Contraceptive methods | Latex condom | CERVICAL CAP FOR CONTRACEPTIVE USE | Vaginal contraceptive diaphragm | Sexual Abstinence
Item
willing to take adequate contraception (i.e. latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after
boolean
C0700589 (UMLS CUI [1])
C3873750 (UMLS CUI [2])
C0493327 (UMLS CUI [3])
C0042241 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
Investigational Therapies Discontinued
Item
all investigational treatments should have been discontinued for at least 1 week prior to the initiation of the study drug.
boolean
C0949266 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Informed Consent Unable | Informed Consent Unwilling
Item
unable or unwilling to sign consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Comorbidity Severe | Investigational Therapy Excluded
Item
severe, ongoing co-morbid conditions, which would preclude safe delivery of the investigational therapy
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0949266 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Communicable Diseases Serious Uncontrolled | Antibiotics
Item
active serious infections that are not controlled by antibiotics
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0003232 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status 4
boolean
C1520224 (UMLS CUI [1])
Abnormal renal function | Creatinine measurement, serum | Serum creatinine measurement Disease Related
Item
inadequate renal function: creatinine 2.0 or more unless related to the disease
boolean
C0151746 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0201976 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
Liver function abnormal | Serum total bilirubin measurement | Transaminases increased | Transaminases increased Disease Related
Item
inadequate liver function: bilirubin 3.0 or more, transaminases 3 x upper limit of normal or more unless related to the disease
boolean
C0151766 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0438717 (UMLS CUI [3])
C0438717 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
HIV Seropositivity
Item
known positive test for hiv
boolean
C0019699 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
patients with known hepatitis b and/or hepatitis c active infection
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
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