Adult | Age
Item
adults (aged ≥ 18 years)
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
B-Cell Lymphoma | Prior Therapy | Disease Progression | Standard therapy Effective Lacking
Item
histologically confirmed diagnosis of a b-cell lymphoma that has progressed in spite of prior treatment, and for which additional effective standard therapy is not available
boolean
C0079731 (UMLS CUI [1])
C1514463 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
C2936643 (UMLS CUI [4,1])
C1280519 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Laboratory Procedures Hematologic function | Laboratory Procedures Renal function | Laboratory Procedures Liver function | Laboratory Procedures Blood coagulation
Item
adequate hematological, renal, hepatic, and coagulation laboratory assessments
boolean
C0022885 (UMLS CUI [1,1])
C0221130 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2,1])
C0232804 (UMLS CUI [2,2])
C0022885 (UMLS CUI [3,1])
C0232741 (UMLS CUI [3,2])
C0022885 (UMLS CUI [4,1])
C0005778 (UMLS CUI [4,2])
Informed Consent
Item
must give written informed consent to participate in this study before the performance of any study-related procedure
boolean
C0021430 (UMLS CUI [1])
Primary central nervous system lymphoma | Central Nervous System Involvement Lymphomatous
Item
a primary lymphoma of the central nervous system (cns) or known lymphomatous involvement of the cns
boolean
C0280803 (UMLS CUI [1])
C4050309 (UMLS CUI [2,1])
C0024299 (UMLS CUI [2,2])
Impaired gastrointestinal system function Changing Absorption CPI-1205 | Gastrointestinal Disease Changing Absorption CPI-1205 | Nausea CTCAE Grades | Vomiting CTCAE Grades | Diarrhea CTCAE Grades
Item
impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of cpi-1205, including any unresolved nausea, vomiting, or diarrhea that is ctcae grade >1
boolean
C0232459 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C4053654 (UMLS CUI [1,4])
C0017178 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C4053654 (UMLS CUI [2,4])
C0027497 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
C0042963 (UMLS CUI [4,1])
C1516728 (UMLS CUI [4,2])
C0011991 (UMLS CUI [5,1])
C1516728 (UMLS CUI [5,2])
Proton Pump Inhibitors | H2 Antagonists | Antacids
Item
treatment with proton pump inhibitors, h2 antagonists, or antacids
boolean
C0358591 (UMLS CUI [1])
C0019593 (UMLS CUI [2])
C0003138 (UMLS CUI [3])
Achlorhydria | Achlorhydria Suspected Due to Comorbidity | Anemia, Pernicious | Gastritis, Atrophic | Operation on stomach
Item
achlorhydria, either documented or suspected on the basis of an associated disease (e.g., pernicious anemia, atrophic gastritis, or certain gastric surgical procedures)
boolean
C0001075 (UMLS CUI [1])
C0001075 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0009488 (UMLS CUI [2,4])
C0002892 (UMLS CUI [3])
C0017154 (UMLS CUI [4])
C0192398 (UMLS CUI [5])
Decreased cardiac function | Heart Diseases Clinical Significance
Item
impaired cardiac function or clinically significant cardiac diseases, including any of the following:
boolean
C0232166 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
Myocardial Infarction | Angina Pectoris
Item
acute myocardial infarction or angina pectoris ≤ 6 months prior to starting study drug
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
Congestive heart failure New York Heart Association Classification
Item
new york heart association class iii or iv congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
QTcF Prolongation ECG
Item
qtcf > 470 msec on the screening ecg
boolean
C3828431 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Cardiac Arrhythmia Uncontrolled | ATRIAL FIBRILLATION VENTRICULAR RATE CONTROLLED allowed
Item
uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded)
boolean
C0003811 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0741286 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Cardiovascular Disease Medical History | Uncontrolled hypertension | Labile hypertension | Antihypertensive therapy Poor compliance
Item
a past medical history of other clinically significant cardiovascular disease (e.g., uncontrolled hypertension, history of labile hypertension or history of poor compliance with an antihypertensive regimen)
boolean
C0007222 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])
C3665418 (UMLS CUI [3])
C0585941 (UMLS CUI [4,1])
C0032646 (UMLS CUI [4,2])
Comorbidity Severe compromises Study Subject Participation Status | Comorbidity Uncontrolled compromises Study Subject Participation Status | Lung diseases | Nervous system disorder | Communicable Disease | Communicable Disease Uncontrolled
Item
any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study (e.g., clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection)
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0024115 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
C0009450 (UMLS CUI [5])
C0009450 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
Cancer treatment Systemic | Therapeutic radiology procedure Systemic | Status pre- CPI-1205 Dose
Item
systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first dose of cpi 1205
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0332152 (UMLS CUI [3,1])
C4053654 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
Radioimmunotherapy | iodine-131-tositumomab | yttrium-90-ibritumomab tiuxetan | Status pre- CPI-1205 Dose
Item
radioimmunotherapy (e.g., 131i-tositumomab, 90y-ibritumomab tiuxetan) less than 6 weeks before the first dose of cpi-1205
boolean
C0085101 (UMLS CUI [1])
C0768182 (UMLS CUI [2])
C1134535 (UMLS CUI [3])
C0332152 (UMLS CUI [4,1])
C4053654 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
Small Molecule Investigational | Status pre- CPI-1205 Dose
Item
treatment with an investigational small molecule less than 2 weeks before the first dose of cpi-1205.
boolean
C1328819 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C4053654 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
Antibody therapy | Status pre- CPI-1205 Dose
Item
treatment with a therapeutic antibody less than 4 weeks before the first dose of cpi-1205.
boolean
C0281176 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C4053654 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
CYP3A4 Inhibitor
Item
treatment with medications that are strong inhibitors of cyp3a4
boolean
C3830624 (UMLS CUI [1])
CYP3A4 Inducer
Item
treatment with medications that are inducers of cyp3a4 enzymes
boolean
C3830625 (UMLS CUI [1])
Pharmaceutical Preparations At risk Torsades de Pointes
Item
treatment with medications that are known to carry a risk of torsades de pointes
boolean
C0013227 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0040479 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Females & males of reproductive potential Contraceptive methods Unwilling
Item
women of child bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
patients unwilling or unable to comply with this study protocol
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])