ID

41032

Description

Ofatumumab vs Physician's Choice in Subjects With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01313689

Link

https://clinicaltrials.gov/show/NCT01313689

Keywords

Versions (1)
  1. 6/15/20 6/15/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 15, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukaemia, Lymphocytic, Chronic NCT01313689

English

Eligibility Leukaemia, Lymphocytic, Chronic NCT01313689

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adults with documented diagnosis of active cll requiring treatment
Description

Adult | Chronic Lymphocytic Leukemia Treatment required for

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2,1]
C0023434
UMLS CUI [2,2]
C0332121
bulky lymphadenopathy, defined as at least 1 lymph node >5 cm
Description

Lymphadenopathy Bulky | Lymph node Size Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0497156
UMLS CUI [1,2]
C0555954
UMLS CUI [2,1]
C0024204
UMLS CUI [2,2]
C0456389
UMLS CUI [2,3]
C1265611
must be refractory to fludarabine treatment
Description

Unresponsive to Fludarabine

Data type

boolean

Alias
UMLS CUI [1,1]
C0205269
UMLS CUI [1,2]
C0059985
age 18 yrs or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
at least 2 prior therapies for cll
Description

Prior Therapy Quantity CLL

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0023434
eastern cooperative oncology group (ecog) performance status of 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
signed written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior allogeneic stem cell transplant at any time, or autologous stem cell transplant within 6 months
Description

Allogeneic hematopoietic stem cell transplant | Autologous hematopoietic stem cell transplant

Data type

boolean

Alias
UMLS CUI [1]
C4255274
UMLS CUI [2]
C2193200
treatment with any unapproved drug substance or experimental therapy within 4 weeks, or currently participating in another interventional clinical study
Description

Drugs, Non-Prescription | Therapy, Investigational | Study Subject Participation Status | Interventional Study

Data type

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2]
C0949266
UMLS CUI [3]
C2348568
UMLS CUI [4]
C3274035
cll transformation, prolymphocytic leukemia, or central nervous system (cns) involvement of cll
Description

Chronic lymphocytic leukaemia transformation | Prolymphocytic Leukemia | Central Nervous System Involvement CLL

Data type

boolean

Alias
UMLS CUI [1]
C1142081
UMLS CUI [2]
C0023486
UMLS CUI [3,1]
C4050309
UMLS CUI [3,2]
C0023434
active autoimmune hemolytic anemia (aiha) requiring treatment except if associated with progressive disease requiring anti-cll treatment
Description

Autoimmune hemolytic anemia Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0002880
UMLS CUI [1,2]
C0332121
chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
Description

Chronic infectious disease | Communicable Disease | Requirement Antibiotics for systemic use | Requirement Antifungal treatment | Requirement Antiviral treatment

Data type

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2]
C0009450
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C3540704
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C2363963
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C2363964
human immunodeficiency virus (hiv) positive
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
significant concurrent, uncontrolled medical condition
Description

Comorbidity Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
other past or current malignancy (with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix or breast) unless the tumor was successfully treated with curative intent at least 2 years prior to trial entry
Description

Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Exception Cancer treatment Curative Successful

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0686288
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0920425
UMLS CUI [5,3]
C1276305
UMLS CUI [5,4]
C1272703
non-protocol corticosteroid usage except a maintenance dose corresponding to less than or equal to 10 mg prednisone
Description

Adrenal Cortex Hormones | Exception Maintenance Dose | Exception Equivalent Prednisone Dose

Data type

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0024501
UMLS CUI [2,3]
C0178602
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0205163
UMLS CUI [3,3]
C0032952
UMLS CUI [3,4]
C0178602
abnormal lab values: creatinine > 2.0 times upper normal limit (unless normal creatinine clearance), or total bilirubin > 2.0 times upper normal limit (unless due to liver involvement of cll or due to gilbert's syndrome), or alanine transaminase (alt) > 2.5 times upper normal limit (unless due to liver involvement of cll)
Description

Laboratory test result abnormal | Creatinine increased | Exception Creatinine clearance Normal | Elevated total bilirubin | Exception Liver Involvement with CLL | Exception Gilbert Disease | Alanine aminotransferase increased | Exception Liver Involvement with CLL

Data type

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0151578
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0373595
UMLS CUI [3,3]
C0205307
UMLS CUI [4]
C0741494
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0023884
UMLS CUI [5,3]
C1314939
UMLS CUI [5,4]
C0023434
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0017551
UMLS CUI [7]
C0151905
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0023884
UMLS CUI [8,3]
C1314939
UMLS CUI [8,4]
C0023434
known or suspected hypersensitivity to ofatumumab
Description

Hypersensitivity Ofatumumab | Hypersensitivity Suspected Ofatumumab

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1832027
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C1832027
lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception
Description

Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Partner Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0682323
UMLS CUI [4,3]
C0700589
UMLS CUI [4,4]
C0558080
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Similar models

Eligibility Leukaemia, Lymphocytic, Chronic NCT01313689

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Chronic Lymphocytic Leukemia Treatment required for
Item
adults with documented diagnosis of active cll requiring treatment
boolean
C0001675 (UMLS CUI [1])
C0023434 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Lymphadenopathy Bulky | Lymph node Size Quantity
Item
bulky lymphadenopathy, defined as at least 1 lymph node >5 cm
boolean
C0497156 (UMLS CUI [1,1])
C0555954 (UMLS CUI [1,2])
C0024204 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Unresponsive to Fludarabine
Item
must be refractory to fludarabine treatment
boolean
C0205269 (UMLS CUI [1,1])
C0059985 (UMLS CUI [1,2])
Age
Item
age 18 yrs or older
boolean
C0001779 (UMLS CUI [1])
Prior Therapy Quantity CLL
Item
at least 2 prior therapies for cll
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Allogeneic hematopoietic stem cell transplant | Autologous hematopoietic stem cell transplant
Item
prior allogeneic stem cell transplant at any time, or autologous stem cell transplant within 6 months
boolean
C4255274 (UMLS CUI [1])
C2193200 (UMLS CUI [2])
Drugs, Non-Prescription | Therapy, Investigational | Study Subject Participation Status | Interventional Study
Item
treatment with any unapproved drug substance or experimental therapy within 4 weeks, or currently participating in another interventional clinical study
boolean
C0013231 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
C2348568 (UMLS CUI [3])
C3274035 (UMLS CUI [4])
Chronic lymphocytic leukaemia transformation | Prolymphocytic Leukemia | Central Nervous System Involvement CLL
Item
cll transformation, prolymphocytic leukemia, or central nervous system (cns) involvement of cll
boolean
C1142081 (UMLS CUI [1])
C0023486 (UMLS CUI [2])
C4050309 (UMLS CUI [3,1])
C0023434 (UMLS CUI [3,2])
Autoimmune hemolytic anemia Treatment required for
Item
active autoimmune hemolytic anemia (aiha) requiring treatment except if associated with progressive disease requiring anti-cll treatment
boolean
C0002880 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Chronic infectious disease | Communicable Disease | Requirement Antibiotics for systemic use | Requirement Antifungal treatment | Requirement Antiviral treatment
Item
chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
boolean
C0151317 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C3540704 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C2363963 (UMLS CUI [4,2])
C1514873 (UMLS CUI [5,1])
C2363964 (UMLS CUI [5,2])
HIV Seropositivity
Item
human immunodeficiency virus (hiv) positive
boolean
C0019699 (UMLS CUI [1])
Comorbidity Uncontrolled
Item
significant concurrent, uncontrolled medical condition
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Exception Cancer treatment Curative Successful
Item
other past or current malignancy (with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix or breast) unless the tumor was successfully treated with curative intent at least 2 years prior to trial entry
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0686288 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0920425 (UMLS CUI [5,2])
C1276305 (UMLS CUI [5,3])
C1272703 (UMLS CUI [5,4])
Adrenal Cortex Hormones | Exception Maintenance Dose | Exception Equivalent Prednisone Dose
Item
non-protocol corticosteroid usage except a maintenance dose corresponding to less than or equal to 10 mg prednisone
boolean
C0001617 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0024501 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C0032952 (UMLS CUI [3,3])
C0178602 (UMLS CUI [3,4])
Laboratory test result abnormal | Creatinine increased | Exception Creatinine clearance Normal | Elevated total bilirubin | Exception Liver Involvement with CLL | Exception Gilbert Disease | Alanine aminotransferase increased | Exception Liver Involvement with CLL
Item
abnormal lab values: creatinine > 2.0 times upper normal limit (unless normal creatinine clearance), or total bilirubin > 2.0 times upper normal limit (unless due to liver involvement of cll or due to gilbert's syndrome), or alanine transaminase (alt) > 2.5 times upper normal limit (unless due to liver involvement of cll)
boolean
C0438215 (UMLS CUI [1])
C0151578 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0373595 (UMLS CUI [3,2])
C0205307 (UMLS CUI [3,3])
C0741494 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0023884 (UMLS CUI [5,2])
C1314939 (UMLS CUI [5,3])
C0023434 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0017551 (UMLS CUI [6,2])
C0151905 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C0023884 (UMLS CUI [8,2])
C1314939 (UMLS CUI [8,3])
C0023434 (UMLS CUI [8,4])
Hypersensitivity Ofatumumab | Hypersensitivity Suspected Ofatumumab
Item
known or suspected hypersensitivity to ofatumumab
boolean
C0020517 (UMLS CUI [1,1])
C1832027 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1832027 (UMLS CUI [2,3])
Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Partner Contraceptive methods Unwilling
Item
lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0682323 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
C0558080 (UMLS CUI [4,4])
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