ID

35338

Description

Safety, Tolerability and Efficacy of A6 in Patients With Chronic Lymphocytic Leukemia (CLL); ODM derived from: https://clinicaltrials.gov/show/NCT02046928

Link

https://clinicaltrials.gov/show/NCT02046928

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 NCT02046928

English

Eligibility Chronic Lymphocytic Leukemia NCT02046928

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of cll or sll based on iwcll criteria
Description

Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2]
C0855095
measurable or evaluable disease based on iwcll criteria
Description

Measurable Disease | Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
previously untreated patients who have been counseled on approved alternative therapeutic options. not a candidate for fludarabine/cyclophosphamide/rituximab (fcr) or has preference to not receive chemotherapy.
Description

Prior Therapy Absent | Patients Inappropriate Cyclophosphamide/fludarabine/rituximab | Chemotherapy Unfavorable

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C1327865
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C3640815
eastern cooperative oncology group (ecog) status of 0-2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow, renal, liver, cardiac and pulmonary function.
Description

Bone Marrow function | Renal function | Liver function | Cardiac function | Pulmonary function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0232164
UMLS CUI [5]
C0231921
life expectancy of greater than or equal to 6 months.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
receipt of other cancer therapy, immunomodulatory drug therapy or immunosuppressive therapy within 4 weeks prior to 1st dose.
Description

Cancer treatment Other | Immunomodulation | Therapeutic immunosuppression

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C1963758
UMLS CUI [3]
C0021079
receipt of corticosteroids > 20 mg/day within 4 weeks prior to1st dose
Description

Adrenal Cortex Hormones U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0456683
major surgery or radiation within 4 weeks prior to 1st dose
Description

Major surgery | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C1522449
presence of uncontrolled infection requiring systemic therapy
Description

Communicable Disease Uncontrolled | Patient need for Systemic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C1515119
active second malignancy other than non-melanoma skin cancer
Description

Second malignancy | Exception Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0085183
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
uncontrolled autoimmune anemia or thrombocytopenia
Description

Autoimmune anaemia Uncontrolled | Thrombocytopenia Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C4524207
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0040034
UMLS CUI [2,2]
C0205318
receipt of any investigational agent within 4 weeks prior to 1st dose
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
pregnant or lactating female
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any severe, acute or chronic medical or psychiatric condition, or lab abnormality that may increase the risk associated with trial participation, study drug administration or interfere with informed consent process or compliance with requirements of the trial.
Description

Severe medical condition Study Subject Participation Status At risk | Severe medical condition Investigational New Drugs At risk | Severe medical condition Interferes with Informed Consent | Severe medical condition Interferes with Protocol Compliance | Medical condition Study Subject Participation Status At risk | Medical condition Investigational New Drugs At risk | Medical condition Interferes with Informed Consent | Medical condition Interferes with Protocol Compliance | Chronic disease Study Subject Participation Status At risk | Chronic disease Investigational New Drugs At risk | Chronic disease Interferes with Informed Consent | Chronic disease Interferes with Protocol Compliance | Severe Mental Disorder Study Subject Participation Status At risk | Severe Mental Disorder Investigational New Drugs At risk | Severe Mental Disorder Interferes with Informed Consent | Severe Mental Disorder Interferes with Protocol Compliance | Mental disorders Study Subject Participation Status At risk | Mental disorders Investigational New Drugs At risk | Mental disorder Interferes with Informed Consent | Mental disorder Interferes with Protocol Compliance | Chronic mental disorder Study Subject Participation Status At risk | Chronic mental disorder Investigational New Drugs At risk | Chronic mental disorder Interferes with Informed Consent | Chronic mental disorder Interferes with Protocol Compliance | Laboratory test result abnormal Study Subject Participation Status At risk | Laboratory test result abnormal Investigational New Drugs At risk | Laboratory test result abnormal Interferes with Informed Consent | Laboratory test result abnormal Interferes with Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C1444641
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0013230
UMLS CUI [2,4]
C1444641
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0021430
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C0525058
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C2348568
UMLS CUI [5,3]
C1444641
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0013230
UMLS CUI [6,3]
C1444641
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0021430
UMLS CUI [8,1]
C3843040
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C0525058
UMLS CUI [9,1]
C0008679
UMLS CUI [9,2]
C2348568
UMLS CUI [9,3]
C1444641
UMLS CUI [10,1]
C0008679
UMLS CUI [10,2]
C0013230
UMLS CUI [10,3]
C1444641
UMLS CUI [11,1]
C0008679
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C0021430
UMLS CUI [12,1]
C0008679
UMLS CUI [12,2]
C0521102
UMLS CUI [12,3]
C0525058
UMLS CUI [13,1]
C4046029
UMLS CUI [13,2]
C2348568
UMLS CUI [13,3]
C1444641
UMLS CUI [14,1]
C4046029
UMLS CUI [14,2]
C0013230
UMLS CUI [14,3]
C1444641
UMLS CUI [15,1]
C4046029
UMLS CUI [15,2]
C0521102
UMLS CUI [15,3]
C0021430
UMLS CUI [16,1]
C4046029
UMLS CUI [16,2]
C0521102
UMLS CUI [16,3]
C0525058
UMLS CUI [17,1]
C0004936
UMLS CUI [17,2]
C2348568
UMLS CUI [17,3]
C1444641
UMLS CUI [18,1]
C0004936
UMLS CUI [18,2]
C0013230
UMLS CUI [18,3]
C1444641
UMLS CUI [19,1]
C0004936
UMLS CUI [19,2]
C0521102
UMLS CUI [19,3]
C0021430
UMLS CUI [20,1]
C0004936
UMLS CUI [20,2]
C0521102
UMLS CUI [20,3]
C0525058
UMLS CUI [21,1]
C0870281
UMLS CUI [21,2]
C2348568
UMLS CUI [21,3]
C1444641
UMLS CUI [22,1]
C0870281
UMLS CUI [22,2]
C0013230
UMLS CUI [22,3]
C1444641
UMLS CUI [23,1]
C0870281
UMLS CUI [23,2]
C0521102
UMLS CUI [23,3]
C0021430
UMLS CUI [24,1]
C0870281
UMLS CUI [24,2]
C0521102
UMLS CUI [24,3]
C0525058
UMLS CUI [25,1]
C0438215
UMLS CUI [25,2]
C2348568
UMLS CUI [25,3]
C1444641
UMLS CUI [26,1]
C0438215
UMLS CUI [26,2]
C0013230
UMLS CUI [26,3]
C1444641
UMLS CUI [27,1]
C0438215
UMLS CUI [27,2]
C0521102
UMLS CUI [27,3]
C0021430
UMLS CUI [28,1]
C0438215
UMLS CUI [28,2]
C0521102
UMLS CUI [28,3]
C0525058
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT02046928

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma
Item
confirmed diagnosis of cll or sll based on iwcll criteria
boolean
C0023434 (UMLS CUI [1])
C0855095 (UMLS CUI [2])
Measurable Disease | Evaluable Disease
Item
measurable or evaluable disease based on iwcll criteria
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Prior Therapy Absent | Patients Inappropriate Cyclophosphamide/fludarabine/rituximab | Chemotherapy Unfavorable
Item
previously untreated patients who have been counseled on approved alternative therapeutic options. not a candidate for fludarabine/cyclophosphamide/rituximab (fcr) or has preference to not receive chemotherapy.
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C1327865 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C3640815 (UMLS CUI [3,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) status of 0-2.
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Renal function | Liver function | Cardiac function | Pulmonary function
Item
adequate bone marrow, renal, liver, cardiac and pulmonary function.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0232164 (UMLS CUI [4])
C0231921 (UMLS CUI [5])
Life Expectancy
Item
life expectancy of greater than or equal to 6 months.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer treatment Other | Immunomodulation | Therapeutic immunosuppression
Item
receipt of other cancer therapy, immunomodulatory drug therapy or immunosuppressive therapy within 4 weeks prior to 1st dose.
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1963758 (UMLS CUI [2])
C0021079 (UMLS CUI [3])
Adrenal Cortex Hormones U/day
Item
receipt of corticosteroids > 20 mg/day within 4 weeks prior to1st dose
boolean
C0001617 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Major surgery | Therapeutic radiology procedure
Item
major surgery or radiation within 4 weeks prior to 1st dose
boolean
C0679637 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Communicable Disease Uncontrolled | Patient need for Systemic therapy
Item
presence of uncontrolled infection requiring systemic therapy
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C1515119 (UMLS CUI [2,2])
Second malignancy | Exception Skin carcinoma
Item
active second malignancy other than non-melanoma skin cancer
boolean
C0085183 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Autoimmune anaemia Uncontrolled | Thrombocytopenia Uncontrolled
Item
uncontrolled autoimmune anemia or thrombocytopenia
boolean
C4524207 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0040034 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Investigational New Drugs
Item
receipt of any investigational agent within 4 weeks prior to 1st dose
boolean
C0013230 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating female
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Severe medical condition Study Subject Participation Status At risk | Severe medical condition Investigational New Drugs At risk | Severe medical condition Interferes with Informed Consent | Severe medical condition Interferes with Protocol Compliance | Medical condition Study Subject Participation Status At risk | Medical condition Investigational New Drugs At risk | Medical condition Interferes with Informed Consent | Medical condition Interferes with Protocol Compliance | Chronic disease Study Subject Participation Status At risk | Chronic disease Investigational New Drugs At risk | Chronic disease Interferes with Informed Consent | Chronic disease Interferes with Protocol Compliance | Severe Mental Disorder Study Subject Participation Status At risk | Severe Mental Disorder Investigational New Drugs At risk | Severe Mental Disorder Interferes with Informed Consent | Severe Mental Disorder Interferes with Protocol Compliance | Mental disorders Study Subject Participation Status At risk | Mental disorders Investigational New Drugs At risk | Mental disorder Interferes with Informed Consent | Mental disorder Interferes with Protocol Compliance | Chronic mental disorder Study Subject Participation Status At risk | Chronic mental disorder Investigational New Drugs At risk | Chronic mental disorder Interferes with Informed Consent | Chronic mental disorder Interferes with Protocol Compliance | Laboratory test result abnormal Study Subject Participation Status At risk | Laboratory test result abnormal Investigational New Drugs At risk | Laboratory test result abnormal Interferes with Informed Consent | Laboratory test result abnormal Interferes with Protocol Compliance
Item
any severe, acute or chronic medical or psychiatric condition, or lab abnormality that may increase the risk associated with trial participation, study drug administration or interfere with informed consent process or compliance with requirements of the trial.
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1444641 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C1444641 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0021430 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C0525058 (UMLS CUI [4,4])
C3843040 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C0013230 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C3843040 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0021430 (UMLS CUI [7,3])
C3843040 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])
C0008679 (UMLS CUI [9,1])
C2348568 (UMLS CUI [9,2])
C1444641 (UMLS CUI [9,3])
C0008679 (UMLS CUI [10,1])
C0013230 (UMLS CUI [10,2])
C1444641 (UMLS CUI [10,3])
C0008679 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0021430 (UMLS CUI [11,3])
C0008679 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C0525058 (UMLS CUI [12,3])
C4046029 (UMLS CUI [13,1])
C2348568 (UMLS CUI [13,2])
C1444641 (UMLS CUI [13,3])
C4046029 (UMLS CUI [14,1])
C0013230 (UMLS CUI [14,2])
C1444641 (UMLS CUI [14,3])
C4046029 (UMLS CUI [15,1])
C0521102 (UMLS CUI [15,2])
C0021430 (UMLS CUI [15,3])
C4046029 (UMLS CUI [16,1])
C0521102 (UMLS CUI [16,2])
C0525058 (UMLS CUI [16,3])
C0004936 (UMLS CUI [17,1])
C2348568 (UMLS CUI [17,2])
C1444641 (UMLS CUI [17,3])
C0004936 (UMLS CUI [18,1])
C0013230 (UMLS CUI [18,2])
C1444641 (UMLS CUI [18,3])
C0004936 (UMLS CUI [19,1])
C0521102 (UMLS CUI [19,2])
C0021430 (UMLS CUI [19,3])
C0004936 (UMLS CUI [20,1])
C0521102 (UMLS CUI [20,2])
C0525058 (UMLS CUI [20,3])
C0870281 (UMLS CUI [21,1])
C2348568 (UMLS CUI [21,2])
C1444641 (UMLS CUI [21,3])
C0870281 (UMLS CUI [22,1])
C0013230 (UMLS CUI [22,2])
C1444641 (UMLS CUI [22,3])
C0870281 (UMLS CUI [23,1])
C0521102 (UMLS CUI [23,2])
C0021430 (UMLS CUI [23,3])
C0870281 (UMLS CUI [24,1])
C0521102 (UMLS CUI [24,2])
C0525058 (UMLS CUI [24,3])
C0438215 (UMLS CUI [25,1])
C2348568 (UMLS CUI [25,2])
C1444641 (UMLS CUI [25,3])
C0438215 (UMLS CUI [26,1])
C0013230 (UMLS CUI [26,2])
C1444641 (UMLS CUI [26,3])
C0438215 (UMLS CUI [27,1])
C0521102 (UMLS CUI [27,2])
C0021430 (UMLS CUI [27,3])
C0438215 (UMLS CUI [28,1])
C0521102 (UMLS CUI [28,2])
C0525058 (UMLS CUI [28,3])
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