ID

28074

Description

Activity & Safety Study of Lenalidomide & Rituximab as Non-chemotherapy Based Therapy on Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01185262

Link

https://clinicaltrials.gov/show/NCT01185262

Keywords

  1. 12/14/17 12/14/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 14, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Chronic Lymphocytic Leukemia NCT01185262

Eligibility Chronic Lymphocytic Leukemia NCT01185262

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
recurrent and refractory cll patients that have received at least one previous treatment with purine analogs.
Description

Recurrent Chronic Lymphoid Leukemia | Chronic lymphocytic leukaemia refractory | Prior Therapy Quantity Purine analog

Data type

boolean

Alias
UMLS CUI [1]
C0854802
UMLS CUI [2]
C0278791
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C1268902
adequate liver function and renal function.
Description

Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
ecog performance status ≤ 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
male and female patients who are fertile agree to use an effective barrier method of birth control to avoid pregnancy.
Description

Fertility Barrier Contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0004764
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive serological markers for hepatitis b with the exception of hbsac in previously vaccinated patients
Description

Serology positive Hepatitis B | Exception HBsAg Patients Vaccinated

Data type

boolean

Alias
UMLS CUI [1,1]
C0242089
UMLS CUI [1,2]
C0019163
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019168
UMLS CUI [2,3]
C0030705
UMLS CUI [2,4]
C1519885
pregnant patients
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
hiv infection
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
concurrent chemotherapy or immunotherapy
Description

Chemotherapy | Immunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0021083
other malignancy within the last 2 years, except for localized cutaneous carcinoma
Description

Cancer Other | Exception Skin carcinoma Localized

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C0392752
neurological impairment precluding understanding of protocol and the entailed visits and procedures.
Description

Neurologic Deficits Exclude Comprehension Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0521654
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C2348563
patients with renal insufficiency that requires dialysis.
Description

Renal Insufficiency Requirement Dialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0011946

Similar models

Eligibility Chronic Lymphocytic Leukemia NCT01185262

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Recurrent Chronic Lymphoid Leukemia | Chronic lymphocytic leukaemia refractory | Prior Therapy Quantity Purine analog
Item
recurrent and refractory cll patients that have received at least one previous treatment with purine analogs.
boolean
C0854802 (UMLS CUI [1])
C0278791 (UMLS CUI [2])
C1514463 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1268902 (UMLS CUI [3,3])
Liver function | Renal function
Item
adequate liver function and renal function.
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status ≤ 2.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Fertility Barrier Contraception
Item
male and female patients who are fertile agree to use an effective barrier method of birth control to avoid pregnancy.
boolean
C0015895 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Serology positive Hepatitis B | Exception HBsAg Patients Vaccinated
Item
positive serological markers for hepatitis b with the exception of hbsac in previously vaccinated patients
boolean
C0242089 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0019168 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
C1519885 (UMLS CUI [2,4])
Pregnancy
Item
pregnant patients
boolean
C0032961 (UMLS CUI [1])
HIV Infection
Item
hiv infection
boolean
C0019693 (UMLS CUI [1])
Chemotherapy | Immunotherapy
Item
concurrent chemotherapy or immunotherapy
boolean
C0392920 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
Cancer Other | Exception Skin carcinoma Localized
Item
other malignancy within the last 2 years, except for localized cutaneous carcinoma
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C0392752 (UMLS CUI [2,3])
Neurologic Deficits Exclude Comprehension Study Protocol
Item
neurological impairment precluding understanding of protocol and the entailed visits and procedures.
boolean
C0521654 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
Renal Insufficiency Requirement Dialysis
Item
patients with renal insufficiency that requires dialysis.
boolean
C1565489 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])

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