B-Cell Lymphoma indolent | Lymphoma, Follicular | Marginal Zone B-Cell Lymphoma | Transformation Absent | Signs Transformation Absent
Item
histologically confirmed diagnosis of b-cell indolent non-hodgkin lymphoma with histological subtype limited to follicular lymphoma or marginal zone lymphoma, at initial diagnosis and without evidence of pathological transformation or clinical signs suggesting transformation
boolean
C0079731 (UMLS CUI [1,1])
C0234227 (UMLS CUI [1,2])
C0024301 (UMLS CUI [2])
C1367654 (UMLS CUI [3])
C0040682 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0311392 (UMLS CUI [5,1])
C0040682 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Prior Therapy Quantity | Chemoimmunotherapy Anti-CD20 Antibody
Item
at least 1 prior treatment with a cd20 antibody combination chemo-immunotherapy regimen
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2986423 (UMLS CUI [2,1])
C3891557 (UMLS CUI [2,2])
Recurrent disease | Refractory Disease | Status post Chemoimmunotherapy
Item
disease that has relapsed or was refractory after prior chemo-immunotherapy
boolean
C0277556 (UMLS CUI [1])
C1514815 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C2986423 (UMLS CUI [3,2])
Measurable Disease Site Quantity
Item
at least 1 measurable site of disease according to revised response criteria for malignant lymphoma 2007
boolean
C1513041 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
ECOG performance status
Item
eastern cooperative oncology group performance status grade 0 or 1
boolean
C1520224 (UMLS CUI [1])
Laboratory Results Study Protocol
Item
laboratory values within protocol-defined parameters
boolean
C1254595 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Contraceptive methods Study Protocol
Item
agrees to protocol-defined use of effective contraception
boolean
C0700589 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Gender Sperm donation Absent | bendamustine | rituximab | Investigational New Drugs
Item
men must agree not to donate sperm during and after the study for 6 months after the last dose of bendamustine, 12 months after the last dose of rituximab, or 3 months after the last dose of study medication, whichever is later
boolean
C0079399 (UMLS CUI [1,1])
C0871414 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0525079 (UMLS CUI [2])
C0393022 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
women of childbearing potential must have a negative serum or urine pregnancy test at screening
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Prior Therapy Study Protocol Criteria
Item
prior treatment according to protocol-defined criteria
boolean
C1514463 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Background Chemotherapy Unable | Etiology Prior Therapy | Etiology Cardiac function
Item
unable to receive background chemotherapy based on prior treatment history and cardiac function
boolean
C1706907 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0232164 (UMLS CUI [3,2])
Central nervous system lymphoma
Item
known central nervous system lymphoma
boolean
C0742472 (UMLS CUI [1])
Malignant Neoplasms | Cancer treatment | Exception Non-Hodgkin Lymphoma indolent
Item
diagnosed or treated for malignancy other than indolent non-hodgkin lymphoma
boolean
C0006826 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0024305 (UMLS CUI [3,2])
C0234227 (UMLS CUI [3,3])
Cerebrovascular accident | Intracranial Hemorrhage
Item
history of stroke or intracranial hemorrhage within 6 months prior to randomization
boolean
C0038454 (UMLS CUI [1])
C0151699 (UMLS CUI [2])
Anticoagulation Therapy | Warfarin | Vitamin K Antagonist Equivalent
Item
requires anticoagulation with warfarin or equivalent vitamin k antagonists
boolean
C0003281 (UMLS CUI [1])
C0043031 (UMLS CUI [2])
C2267235 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
CYP3A Inhibitors Strong
Item
requires treatment with strong cyp3a inhibitors
boolean
C3850056 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
Cardiovascular Disease
Item
clinically significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
HIV Infection | Hepatitis C | Hepatitis C virus RNA Polymerase chain reaction positive | Hepatitis B | Hepatitis B virus DNA Polymerase chain reaction positive | Sepsis Uncontrolled | Requirement Antibiotics Intravenous
Item
known history of human immunodeficiency virus or active hepatitis c virus (hcv; ribonucleic acid [rna] polymerase chain reaction [pcr]-positive) or active hepatitis b virus (hbv; dna pcr-positive) infection or any uncontrolled active systemic infection requiring intravenous antibiotics
boolean
C0019693 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0369335 (UMLS CUI [3,1])
C3888499 (UMLS CUI [3,2])
C0019163 (UMLS CUI [4])
C0369332 (UMLS CUI [5,1])
C3888499 (UMLS CUI [5,2])
C0243026 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C1514873 (UMLS CUI [7,1])
C0003232 (UMLS CUI [7,2])
C1522726 (UMLS CUI [7,3])
Life threatening illness compromises Patient safety | Medical condition compromises Patient safety | Organ system Dysfunction compromises Patient safety | Life threatening illness Interferes with Absorption Ibrutinib Capsule | Medical condition Interferes with Absorption Ibrutinib Capsule | Organ system Dysfunction Interferes with Absorption Ibrutinib Capsule | Life threatening illness Interferes with Metabolism Ibrutinib Capsule | Medical condition Interferes with Metabolism Ibrutinib Capsule | Organ system Dysfunction Interferes with Metabolism Ibrutinib Capsule | Life threatening illness Research results At risk | Medical condition Research results At risk | Organ system Dysfunction Research results At risk
Item
any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
boolean
C3846017 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0460002 (UMLS CUI [3,1])
C3887504 (UMLS CUI [3,2])
C2945640 (UMLS CUI [3,3])
C1113679 (UMLS CUI [3,4])
C3846017 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0237442 (UMLS CUI [4,3])
C3692991 (UMLS CUI [4,4])
C3843040 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0237442 (UMLS CUI [5,3])
C3692991 (UMLS CUI [5,4])
C0460002 (UMLS CUI [6,1])
C3887504 (UMLS CUI [6,2])
C0521102 (UMLS CUI [6,3])
C0237442 (UMLS CUI [6,4])
C3692991 (UMLS CUI [6,5])
C3846017 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0025519 (UMLS CUI [7,3])
C3692991 (UMLS CUI [7,4])
C3843040 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0025519 (UMLS CUI [8,3])
C3692991 (UMLS CUI [8,4])
C0460002 (UMLS CUI [9,1])
C3887504 (UMLS CUI [9,2])
C0521102 (UMLS CUI [9,3])
C0025519 (UMLS CUI [9,4])
C3692991 (UMLS CUI [9,5])
C3846017 (UMLS CUI [10,1])
C0683954 (UMLS CUI [10,2])
C1444641 (UMLS CUI [10,3])
C3843040 (UMLS CUI [11,1])
C0683954 (UMLS CUI [11,2])
C1444641 (UMLS CUI [11,3])
C0460002 (UMLS CUI [12,1])
C3887504 (UMLS CUI [12,2])
C0683954 (UMLS CUI [12,3])
C1444641 (UMLS CUI [12,4])
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])