ID

28044

Beschreibung

Phase II Study of Forodesine in Subjects With Chronic Lymphocytic Leukemia (CLL); ODM derived from: https://clinicaltrials.gov/show/NCT00640523

Link

https://clinicaltrials.gov/show/NCT00640523

Stichworte

Versionen (1)
  1. 12.12.17 12.12.17 -
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See clinicaltrials.gov

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12. Dezember 2017

DOI

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Eligibility Chronic Lymphocytic Leukemia (CLL) NCT00640523

Englisch

Eligibility Chronic Lymphocytic Leukemia (CLL) NCT00640523

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18 years and older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. diagnosis of cll established by peripheral blood and/or bone marrow examination and using the standard diagnostic criteria.
Beschreibung

Chronic Lymphocytic Leukemia Peripheral blood Test | Chronic Lymphocytic Leukemia Bone Marrow Examination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0229664
UMLS CUI [1,3]
C0022885
UMLS CUI [2,1]
C0023434
UMLS CUI [2,2]
C0005957
3. subjects with rai stage iii or iv, or earlier stage requiring therapy as determined by the 1996 national cancer institute -working group (nci-wg) criterion
Beschreibung

Rai Staging | Treatment required

Datentyp

boolean

Alias
UMLS CUI [1]
C1514715
UMLS CUI [2]
C0332121
4. primary resistant (no cr or pr) or progressive disease after response to at least one prior treatment regimen or treatment naïve subjects who meet at least one of the following criteria.
Beschreibung

Resistance Primary | Complete remission Absent | Partial response Absent | Progressive Disease | Response to treatment Previous Quantity | Subject Therapy naive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013203
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C0677874
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1521726
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C1335499
UMLS CUI [5,1]
C0521982
UMLS CUI [5,2]
C0205156
UMLS CUI [5,3]
C1265611
UMLS CUI [6,1]
C0681850
UMLS CUI [6,2]
C0919936
1. age >65 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. eastern cooperative oncology group (ecog) performance status of 2, 3, or 4
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
3. inability to tolerate standard cytotoxic chemotherapy in the opinion of the treating physician.
Beschreibung

Cytotoxic Chemotherapy Receive Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
5. ecog performance status of 0, 1, or 2 (for subjects with primary resistance or progressive disease after response to at least one prior treatment regimen).
Beschreibung

ECOG performance status | Resistance Primary | Progressive Disease | Response to treatment Previous Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2,1]
C0013203
UMLS CUI [2,2]
C0205225
UMLS CUI [3]
C1335499
UMLS CUI [4,1]
C0521982
UMLS CUI [4,2]
C0205156
UMLS CUI [4,3]
C1265611
6. willing to take adequate contraceptive measures (i.e., latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after, except for patients who are post menopausal or have prior hysterectomy.
Beschreibung

Contraceptive methods Willing | Latex condom | CERVICAL CAP FOR CONTRACEPTIVE USE | Vaginal contraceptive diaphragm | Sexual Abstinence | Exception Postmenopausal state | Exception Hysterectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0600109
UMLS CUI [2]
C3873750
UMLS CUI [3]
C0493327
UMLS CUI [4]
C0042241
UMLS CUI [5]
C0036899
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0232970
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0020699
7. all investigational treatments should have been discontinued for at least 3 weeks prior to the initiation of the study drug.
Beschreibung

Investigational Therapy Discontinued

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or nursing.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

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

Informed Consent Unable | Informed Consent Unwilling

Datentyp

boolean

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

Comorbidity Severe Excludes Investigational Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C0949266
4. active serious infections that are not controlled by antibiotics.
Beschreibung

Communicable Diseases Serious | Antibiotics Control Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0003232
UMLS CUI [2,2]
C0243148
UMLS CUI [2,3]
C0332268
5. ecog performance status >2 (except for treatment naïve subjects where ecog performance status 0, 1 or 5 is excluded).
Beschreibung

ECOG performance status | Exception Subject Therapy naive

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0681850
UMLS CUI [2,3]
C0919936
6. inadequate renal function: creatinine > or equal to 2.0 unless related to the disease.
Beschreibung

Renal function Inadequate | Serum creatinine raised | Exception Disease Relationship

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C0700225
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0439849
7. inadequate liver function: bilirubin > or equal to 3.0; transaminases > or equal to 3.0 times the upper limit of normal unless related to the disease.
Beschreibung

Liver function Inadequate | Serum bilirubin increased | Serum transaminase increased | Exception Disease Relationship

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C0859062
UMLS CUI [3]
C0859350
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C0439849
8. known positive test for human immunodeficiency virus (hiv).
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
9. subjects with known hepatitis b and/or hepatitis c active infection.
Beschreibung

Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
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Ähnliche Modelle

Eligibility Chronic Lymphocytic Leukemia (CLL) NCT00640523

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 18 years and older
boolean
C0001779 (UMLS CUI [1])
Chronic Lymphocytic Leukemia Peripheral blood Test | Chronic Lymphocytic Leukemia Bone Marrow Examination
Item
2. diagnosis of cll established by peripheral blood and/or bone marrow examination and using the standard diagnostic criteria.
boolean
C0023434 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
C0023434 (UMLS CUI [2,1])
C0005957 (UMLS CUI [2,2])
Rai Staging | Treatment required
Item
3. subjects with rai stage iii or iv, or earlier stage requiring therapy as determined by the 1996 national cancer institute -working group (nci-wg) criterion
boolean
C1514715 (UMLS CUI [1])
C0332121 (UMLS CUI [2])
Resistance Primary | Complete remission Absent | Partial response Absent | Progressive Disease | Response to treatment Previous Quantity | Subject Therapy naive
Item
4. primary resistant (no cr or pr) or progressive disease after response to at least one prior treatment regimen or treatment naïve subjects who meet at least one of the following criteria.
boolean
C0013203 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0677874 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1521726 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1335499 (UMLS CUI [4])
C0521982 (UMLS CUI [5,1])
C0205156 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C0681850 (UMLS CUI [6,1])
C0919936 (UMLS CUI [6,2])
Age
Item
1. age >65 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
2. eastern cooperative oncology group (ecog) performance status of 2, 3, or 4
boolean
C1520224 (UMLS CUI [1])
Cytotoxic Chemotherapy Receive Unable
Item
3. inability to tolerate standard cytotoxic chemotherapy in the opinion of the treating physician.
boolean
C0677881 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
ECOG performance status | Resistance Primary | Progressive Disease | Response to treatment Previous Quantity
Item
5. ecog performance status of 0, 1, or 2 (for subjects with primary resistance or progressive disease after response to at least one prior treatment regimen).
boolean
C1520224 (UMLS CUI [1])
C0013203 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C1335499 (UMLS CUI [3])
C0521982 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Contraceptive methods Willing | Latex condom | CERVICAL CAP FOR CONTRACEPTIVE USE | Vaginal contraceptive diaphragm | Sexual Abstinence | Exception Postmenopausal state | Exception Hysterectomy
Item
6. willing to take adequate contraceptive measures (i.e., latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after, except for patients who are post menopausal or have prior hysterectomy.
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C3873750 (UMLS CUI [2])
C0493327 (UMLS CUI [3])
C0042241 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0232970 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0020699 (UMLS CUI [7,2])
Investigational Therapy Discontinued
Item
7. all investigational treatments should have been discontinued for at least 3 weeks 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
1. pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Informed Consent Unable | Informed Consent Unwilling
Item
2. 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 Excludes Investigational Therapy
Item
3. 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])
C0332196 (UMLS CUI [1,3])
C0949266 (UMLS CUI [1,4])
Communicable Diseases Serious | Antibiotics Control Lacking
Item
4. active serious infections that are not controlled by antibiotics.
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0003232 (UMLS CUI [2,1])
C0243148 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
ECOG performance status | Exception Subject Therapy naive
Item
5. ecog performance status >2 (except for treatment naïve subjects where ecog performance status 0, 1 or 5 is excluded).
boolean
C1520224 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0681850 (UMLS CUI [2,2])
C0919936 (UMLS CUI [2,3])
Renal function Inadequate | Serum creatinine raised | Exception Disease Relationship
Item
6. inadequate renal function: creatinine > or equal to 2.0 unless related to the disease.
boolean
C0232804 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0700225 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
Liver function Inadequate | Serum bilirubin increased | Serum transaminase increased | Exception Disease Relationship
Item
7. inadequate liver function: bilirubin > or equal to 3.0; transaminases > or equal to 3.0 times the upper limit of normal unless related to the disease.
boolean
C0232741 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0859062 (UMLS CUI [2])
C0859350 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
HIV Seropositivity
Item
8. known positive test for human immunodeficiency virus (hiv).
boolean
C0019699 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
9. subjects with known hepatitis b and/or hepatitis c active infection.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
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