ID

37676

Description

Efficacy and Safety Study of PCI-32765 Combine With Ofatumumab in CLL; ODM derived from: https://clinicaltrials.gov/show/NCT01217749

Link

https://clinicaltrials.gov/show/NCT01217749

Keywords

Versions (1)
  1. 8/15/19 8/15/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 15, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility B-cell Chronic Lymphocytic Leukemia NCT01217749

English

Eligibility B-cell Chronic Lymphocytic Leukemia NCT01217749

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects with histologically confirmed chronic lymphocytic leukemia (cll), small lymphocytic lymphoma (sll), prolymphocytic leukemia (pll), or richter's transformation arising out of cll/sll as defined by who classification of hematopoietic neoplasms and satisfying ≥ 1 of the following conditions:
Description

Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma | Prolymphocytic Leukemia | Richter's syndrome | Hematopoietic Neoplasms WHO tumor classification

Data type

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2]
C0855095
UMLS CUI [3]
C0023486
UMLS CUI [4]
C0349631
UMLS CUI [5,1]
C0376544
UMLS CUI [5,2]
C1301142
progressive splenomegaly and/or lymphadenopathy identified by physical examination or radiographic studies
Description

Splenomegaly Progressive Physical Examination | Lymphadenopathy Physical Examination | Splenomegaly Progressive Radiography | Lymphadenopathy Radiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0038002
UMLS CUI [1,2]
C0205329
UMLS CUI [1,3]
C0031809
UMLS CUI [2,1]
C0497156
UMLS CUI [2,2]
C0031809
UMLS CUI [3,1]
C0038002
UMLS CUI [3,2]
C0205329
UMLS CUI [3,3]
C0043299
UMLS CUI [4,1]
C0497156
UMLS CUI [4,2]
C0043299
anemia (<11 g/dl) or thrombocytopenia (<100,000/μl) due to bone marrow involvement
Description

Anemia Due to Bone Marrow Involvement | Thrombocytopenia Due to Bone Marrow Involvement

Data type

boolean

Alias
UMLS CUI [1,1]
C0002871
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1517677
UMLS CUI [2,1]
C0040034
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1517677
presence of unintentional weight loss > 10% over the preceding 6 months
Description

Unintentional weight loss Percentage Timespan

Data type

boolean

Alias
UMLS CUI [1,1]
C2363736
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0872291
nci ctcae grade 2 or 3 fatigue
Description

Fatigue CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C1516728
fevers > 100.5 degree or night sweats for > 2 weeks without evidence of infection
Description

Fever | Night sweats | Communicable Disease Absent

Data type

boolean

Alias
UMLS CUI [1]
C0015967
UMLS CUI [2]
C0028081
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0332197
progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of < 6 months
Description

Lymphocytosis Progressive | Doubling Time Anticipated

Data type

boolean

Alias
UMLS CUI [1,1]
C0024282
UMLS CUI [1,2]
C0205329
UMLS CUI [2,1]
C2986483
UMLS CUI [2,2]
C3840775
need for cytoreduction prior to stem cell transplant
Description

Patient need for Cytoreduction Before Stem cell transplant

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0864494
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C1504389
2. subjects must have failed ≥ 2 prior therapies for cll including a nucleoside analog or ≥ 2 prior therapies not including nucleoside analog if there is a contraindication to such therapy
Description

Prior Therapy Quantity failed Chronic Lymphocytic Leukemia | Nucleoside Analog failed

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0231175
UMLS CUI [1,4]
C0023434
UMLS CUI [2,1]
C1579410
UMLS CUI [2,2]
C0231175
3. 10% expression of cd20 on cll/sll cells
Description

CD20 Expressing Cell Measurement CLL Cells | CD20 Expressing Cell Measurement SLL Cells

Data type

boolean

Alias
UMLS CUI [1,1]
C3540684
UMLS CUI [1,2]
C0023434
UMLS CUI [1,3]
C0007634
UMLS CUI [2,1]
C3540684
UMLS CUI [2,2]
C0855095
UMLS CUI [2,3]
C0007634
4. ecog performance status ≤ 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
5. life expectancy ≥ 12 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
6. subjects must have organ and marrow function as defined below:
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
absolute neutrophil count (anc) ≥ 1000/µl in the absence of bone marrow involvement
Description

Absolute neutrophil count | Bone Marrow Involvement Absent

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2,1]
C1517677
UMLS CUI [2,2]
C0332197
platelets ≥ 30,000/μl in the absence of bone marrow involvement
Description

Platelet Count measurement | Bone Marrow Involvement Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2,1]
C1517677
UMLS CUI [2,2]
C0332197
total bilirubin ≤ 1.5 x institutional upper limit of normal unless due to gilbert's disease
Description

Serum total bilirubin measurement | Exception Due to Gilbert Disease

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0017551
ast (sgot) ≤ 2.5 x institutional upper limit of normal unless due to infiltration of the liver
Description

Aspartate aminotransferase measurement | Exception Due to Infiltration Liver

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0332448
UMLS CUI [2,4]
C0023884
creatinine ≤ 2.0 mg/dl or creatinine clearance ≥ 50 ml/min
Description

Creatinine measurement, serum | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
7. no history of prior exposure to ofatumumab
Description

Absence Exposure to Ofatumumab

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C1832027
8. age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
9. body weight ≥ 40 kg
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. a life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of pci-32765 po, or put the study outcomes at undue risk
Description

Life threatening illness compromises Patient safety | Life threatening illness Interferes with Absorption PCI 32765 | Life threatening illness Interferes with Metabolism PCI 32765 | Life threatening illness Research results At risk | Medical condition compromises Patient safety | Medical condition Interferes with Absorption PCI 32765 | Medical condition Interferes with Metabolism PCI 32765 | Medical condition Research results At risk | Organ system Dysfunction compromises Patient safety | Organ system Dysfunction Interferes with Absorption PCI 32765 | Organ system Dysfunction Interferes with Metabolism PCI 32765 | Organ system Dysfunction Research results At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C3846017
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C3846017
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C2830052
UMLS CUI [3,1]
C3846017
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0025519
UMLS CUI [3,4]
C2830052
UMLS CUI [4,1]
C3846017
UMLS CUI [4,2]
C0683954
UMLS CUI [4,3]
C1444641
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C2945640
UMLS CUI [5,3]
C1113679
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0237442
UMLS CUI [6,4]
C2830052
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0025519
UMLS CUI [7,4]
C2830052
UMLS CUI [8,1]
C3843040
UMLS CUI [8,2]
C0683954
UMLS CUI [8,3]
C1444641
UMLS CUI [9,1]
C0460002
UMLS CUI [9,2]
C3887504
UMLS CUI [9,3]
C2945640
UMLS CUI [9,4]
C1113679
UMLS CUI [10,1]
C0460002
UMLS CUI [10,2]
C3887504
UMLS CUI [10,3]
C0521102
UMLS CUI [10,4]
C0237442
UMLS CUI [10,5]
C2830052
UMLS CUI [11,1]
C0460002
UMLS CUI [11,2]
C3887504
UMLS CUI [11,3]
C0521102
UMLS CUI [11,4]
C0025519
UMLS CUI [11,5]
C2830052
UMLS CUI [12,1]
C0460002
UMLS CUI [12,2]
C3887504
UMLS CUI [12,3]
C0683954
UMLS CUI [12,4]
C1444641
2. significant cardiovascular disease
Description

Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
3. any condition which could interfere with the absorption or metabolism of pci-32765 including unable to swallow capsules, malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
Description

Condition Interferes with Absorption PCI 32765 | Condition Interferes with Metabolism PCI 32765 | Lacking Able to swallow Capsules | Malabsorption Syndrome | Disease Affecting Gastrointestinal function | Stomach Excision | Small intestine excision | Ulcerative Colitis | Inflammatory Bowel Disease Symptomatic | Partial bowel obstruction | Intestinal Obstruction Complete

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C2830052
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0025519
UMLS CUI [2,4]
C2830052
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C2712086
UMLS CUI [3,3]
C0006935
UMLS CUI [4]
C0024523
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0516983
UMLS CUI [6]
C1304699
UMLS CUI [7]
C0192601
UMLS CUI [8]
C0009324
UMLS CUI [9,1]
C0021390
UMLS CUI [9,2]
C0231220
UMLS CUI [10]
C1328480
UMLS CUI [11,1]
C0021843
UMLS CUI [11,2]
C0205197
4. known history of human immunodeficiency virus (hiv) or active infection with hepatitis c virus (hcv) or hepatitis b virus (hbv) or any uncontrolled active systemic infection
Description

HIV Infection | Hepatitis C | Hepatitis B | Sepsis Uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019163
UMLS CUI [4,1]
C0243026
UMLS CUI [4,2]
C0205318
5. any anticancer immunotherapy, chemotherapy, radiotherapy, or experimental therapy within 4 weeks before first dose of study drug. corticosteroids for disease-related symptoms are allowed provided 1 week washout occurs
Description

Immunotherapy for cancer | Chemotherapy | Therapeutic radiology procedure | Therapies, Investigational | Adrenal Cortex Hormones Symptoms allowed

Data type

boolean

Alias
UMLS CUI [1]
C0278348
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0949266
UMLS CUI [5,1]
C0001617
UMLS CUI [5,2]
C1457887
UMLS CUI [5,3]
C0683607
6. active central nervous system (cns) involvement by lymphoma
Description

Central nervous system lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0280803
7. major surgery within 4 weeks before first dose of study drug
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
8. lactating or pregnant
Description

Breast Feeding | Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
9. known moderate to severe chronic obstructive pulmonary disease (copd)
Description

Moderate chronic obstructive pulmonary disease | Severe chronic obstructive pulmonary disease

Data type

boolean

Alias
UMLS CUI [1]
C0730605
UMLS CUI [2]
C0730607
10. history of prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for at least 2 years or which will not limit survival to < 2 years
Description

Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Cancer Other Disease Free of | Exception Reduced life expectancy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1707251
UMLS CUI [5,3]
C0012634
UMLS CUI [5,4]
C0332296
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1858274
UMLS CUI [6,3]
C0332197
11. history of grade ≥ 2 toxicity continuing from prior anticancer therapy including radiation
Description

Toxicity CTCAE Grades | Etiology Cancer treatment Including Radiation

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0920425
UMLS CUI [2,3]
C0332257
UMLS CUI [2,4]
C1522449
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Similar models

Eligibility B-cell Chronic Lymphocytic Leukemia NCT01217749

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma | Prolymphocytic Leukemia | Richter's syndrome | Hematopoietic Neoplasms WHO tumor classification
Item
1. subjects with histologically confirmed chronic lymphocytic leukemia (cll), small lymphocytic lymphoma (sll), prolymphocytic leukemia (pll), or richter's transformation arising out of cll/sll as defined by who classification of hematopoietic neoplasms and satisfying ≥ 1 of the following conditions:
boolean
C0023434 (UMLS CUI [1])
C0855095 (UMLS CUI [2])
C0023486 (UMLS CUI [3])
C0349631 (UMLS CUI [4])
C0376544 (UMLS CUI [5,1])
C1301142 (UMLS CUI [5,2])
Splenomegaly Progressive Physical Examination | Lymphadenopathy Physical Examination | Splenomegaly Progressive Radiography | Lymphadenopathy Radiography
Item
progressive splenomegaly and/or lymphadenopathy identified by physical examination or radiographic studies
boolean
C0038002 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C0497156 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C0038002 (UMLS CUI [3,1])
C0205329 (UMLS CUI [3,2])
C0043299 (UMLS CUI [3,3])
C0497156 (UMLS CUI [4,1])
C0043299 (UMLS CUI [4,2])
Anemia Due to Bone Marrow Involvement | Thrombocytopenia Due to Bone Marrow Involvement
Item
anemia (<11 g/dl) or thrombocytopenia (<100,000/μl) due to bone marrow involvement
boolean
C0002871 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1517677 (UMLS CUI [1,3])
C0040034 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1517677 (UMLS CUI [2,3])
Unintentional weight loss Percentage Timespan
Item
presence of unintentional weight loss > 10% over the preceding 6 months
boolean
C2363736 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Fatigue CTCAE Grades
Item
nci ctcae grade 2 or 3 fatigue
boolean
C0015672 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Fever | Night sweats | Communicable Disease Absent
Item
fevers > 100.5 degree or night sweats for > 2 weeks without evidence of infection
boolean
C0015967 (UMLS CUI [1])
C0028081 (UMLS CUI [2])
C0009450 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Lymphocytosis Progressive | Doubling Time Anticipated
Item
progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of < 6 months
boolean
C0024282 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C2986483 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
Patient need for Cytoreduction Before Stem cell transplant
Item
need for cytoreduction prior to stem cell transplant
boolean
C0686904 (UMLS CUI [1,1])
C0864494 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C1504389 (UMLS CUI [1,4])
Prior Therapy Quantity failed Chronic Lymphocytic Leukemia | Nucleoside Analog failed
Item
2. subjects must have failed ≥ 2 prior therapies for cll including a nucleoside analog or ≥ 2 prior therapies not including nucleoside analog if there is a contraindication to such therapy
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0023434 (UMLS CUI [1,4])
C1579410 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
CD20 Expressing Cell Measurement CLL Cells | CD20 Expressing Cell Measurement SLL Cells
Item
3. 10% expression of cd20 on cll/sll cells
boolean
C3540684 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C0007634 (UMLS CUI [1,3])
C3540684 (UMLS CUI [2,1])
C0855095 (UMLS CUI [2,2])
C0007634 (UMLS CUI [2,3])
ECOG performance status
Item
4. ecog performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
5. life expectancy ≥ 12 weeks
boolean
C0023671 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
6. subjects must have organ and marrow function as defined below:
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Absolute neutrophil count | Bone Marrow Involvement Absent
Item
absolute neutrophil count (anc) ≥ 1000/µl in the absence of bone marrow involvement
boolean
C0948762 (UMLS CUI [1])
C1517677 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Platelet Count measurement | Bone Marrow Involvement Absent
Item
platelets ≥ 30,000/μl in the absence of bone marrow involvement
boolean
C0032181 (UMLS CUI [1])
C1517677 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Serum total bilirubin measurement | Exception Due to Gilbert Disease
Item
total bilirubin ≤ 1.5 x institutional upper limit of normal unless due to gilbert's disease
boolean
C1278039 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0017551 (UMLS CUI [2,3])
Aspartate aminotransferase measurement | Exception Due to Infiltration Liver
Item
ast (sgot) ≤ 2.5 x institutional upper limit of normal unless due to infiltration of the liver
boolean
C0201899 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0332448 (UMLS CUI [2,3])
C0023884 (UMLS CUI [2,4])
Creatinine measurement, serum | Creatinine clearance measurement
Item
creatinine ≤ 2.0 mg/dl or creatinine clearance ≥ 50 ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Absence Exposure to Ofatumumab
Item
7. no history of prior exposure to ofatumumab
boolean
C0332197 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C1832027 (UMLS CUI [1,3])
Age
Item
8. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
9. body weight ≥ 40 kg
boolean
C0005910 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Life threatening illness compromises Patient safety | Life threatening illness Interferes with Absorption PCI 32765 | Life threatening illness Interferes with Metabolism PCI 32765 | Life threatening illness Research results At risk | Medical condition compromises Patient safety | Medical condition Interferes with Absorption PCI 32765 | Medical condition Interferes with Metabolism PCI 32765 | Medical condition Research results At risk | Organ system Dysfunction compromises Patient safety | Organ system Dysfunction Interferes with Absorption PCI 32765 | Organ system Dysfunction Interferes with Metabolism PCI 32765 | Organ system Dysfunction Research results At risk
Item
1. a life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of pci-32765 po, or put the study outcomes at undue risk
boolean
C3846017 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C3846017 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C2830052 (UMLS CUI [2,4])
C3846017 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0025519 (UMLS CUI [3,3])
C2830052 (UMLS CUI [3,4])
C3846017 (UMLS CUI [4,1])
C0683954 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0237442 (UMLS CUI [6,3])
C2830052 (UMLS CUI [6,4])
C3843040 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0025519 (UMLS CUI [7,3])
C2830052 (UMLS CUI [7,4])
C3843040 (UMLS CUI [8,1])
C0683954 (UMLS CUI [8,2])
C1444641 (UMLS CUI [8,3])
C0460002 (UMLS CUI [9,1])
C3887504 (UMLS CUI [9,2])
C2945640 (UMLS CUI [9,3])
C1113679 (UMLS CUI [9,4])
C0460002 (UMLS CUI [10,1])
C3887504 (UMLS CUI [10,2])
C0521102 (UMLS CUI [10,3])
C0237442 (UMLS CUI [10,4])
C2830052 (UMLS CUI [10,5])
C0460002 (UMLS CUI [11,1])
C3887504 (UMLS CUI [11,2])
C0521102 (UMLS CUI [11,3])
C0025519 (UMLS CUI [11,4])
C2830052 (UMLS CUI [11,5])
C0460002 (UMLS CUI [12,1])
C3887504 (UMLS CUI [12,2])
C0683954 (UMLS CUI [12,3])
C1444641 (UMLS CUI [12,4])
Cardiovascular Disease
Item
2. significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Condition Interferes with Absorption PCI 32765 | Condition Interferes with Metabolism PCI 32765 | Lacking Able to swallow Capsules | Malabsorption Syndrome | Disease Affecting Gastrointestinal function | Stomach Excision | Small intestine excision | Ulcerative Colitis | Inflammatory Bowel Disease Symptomatic | Partial bowel obstruction | Intestinal Obstruction Complete
Item
3. any condition which could interfere with the absorption or metabolism of pci-32765 including unable to swallow capsules, malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C2830052 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0025519 (UMLS CUI [2,3])
C2830052 (UMLS CUI [2,4])
C0332268 (UMLS CUI [3,1])
C2712086 (UMLS CUI [3,2])
C0006935 (UMLS CUI [3,3])
C0024523 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0516983 (UMLS CUI [5,3])
C1304699 (UMLS CUI [6])
C0192601 (UMLS CUI [7])
C0009324 (UMLS CUI [8])
C0021390 (UMLS CUI [9,1])
C0231220 (UMLS CUI [9,2])
C1328480 (UMLS CUI [10])
C0021843 (UMLS CUI [11,1])
C0205197 (UMLS CUI [11,2])
HIV Infection | Hepatitis C | Hepatitis B | Sepsis Uncontrolled
Item
4. known history of human immunodeficiency virus (hiv) or active infection with hepatitis c virus (hcv) or hepatitis b virus (hbv) or any uncontrolled active systemic infection
boolean
C0019693 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0243026 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Immunotherapy for cancer | Chemotherapy | Therapeutic radiology procedure | Therapies, Investigational | Adrenal Cortex Hormones Symptoms allowed
Item
5. any anticancer immunotherapy, chemotherapy, radiotherapy, or experimental therapy within 4 weeks before first dose of study drug. corticosteroids for disease-related symptoms are allowed provided 1 week washout occurs
boolean
C0278348 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0949266 (UMLS CUI [4])
C0001617 (UMLS CUI [5,1])
C1457887 (UMLS CUI [5,2])
C0683607 (UMLS CUI [5,3])
Central nervous system lymphoma
Item
6. active central nervous system (cns) involvement by lymphoma
boolean
C0280803 (UMLS CUI [1])
Major surgery
Item
7. major surgery within 4 weeks before first dose of study drug
boolean
C0679637 (UMLS CUI [1])
Breast Feeding | Pregnancy
Item
8. lactating or pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Moderate chronic obstructive pulmonary disease | Severe chronic obstructive pulmonary disease
Item
9. known moderate to severe chronic obstructive pulmonary disease (copd)
boolean
C0730605 (UMLS CUI [1])
C0730607 (UMLS CUI [2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Cancer Other Disease Free of | Exception Reduced life expectancy Absent
Item
10. history of prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for at least 2 years or which will not limit survival to < 2 years
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1707251 (UMLS CUI [5,2])
C0012634 (UMLS CUI [5,3])
C0332296 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C1858274 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
Toxicity CTCAE Grades | Etiology Cancer treatment Including Radiation
Item
11. history of grade ≥ 2 toxicity continuing from prior anticancer therapy including radiation
boolean
C0600688 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0920425 (UMLS CUI [2,2])
C0332257 (UMLS CUI [2,3])
C1522449 (UMLS CUI [2,4])
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