Non-Hodgkin Lymphoma Subtype | Mantle cell lymphoma | Mantle cell lymphoma recurrent | Mantle cell lymphoma refractory | Status post Therapeutic procedure Quantity | Ibrutinib | Progressive Disease | Intolerance to Ibrutinib | Ibrutinib Discontinued Due to Adverse event | Diffuse Large B-Cell Lymphoma | Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory | Ineligibility High-dose chemotherapy | Ineligibility Transplantation of autologous hematopoietic stem cell | Etiology Organ dysfunction | Etiology Comorbidity | Etiology Comorbidity pulmonary | Etiology Comorbidity cardiac | Follicular Lymphoma WHO tumor classification | Transformation Absent | Recurrent Follicular Lymphoma | Status post Systemic therapy Quantity | Status post Combined Modality Therapy Containing Anti-CD20 Antibody
Item
has diagnosis and prior treatment for each non-hodgkin's lymphoma (nhl) subtype as defined below: mantle cell lymphoma (mcl): pathologically verified diagnosis of mcl based on local pathology report, relapsed or refractory disease after at least 2 but not more than 5 prior lines of therapy, including at least one cycle of ibrutinib therapy and documented progressive disease (pd) during or after ibrutinib treatment or participants who could not tolerate ibrutinib (ie, discontinued ibrutinib due to adverse events [aes]), b) diffuse large b cell lymphoma (dlbcl): pathologically confirmed diagnosis of non-transformed dlbcl, and c) relapsed or refractory disease; participants are not eligible or considered a candidate for high-dose chemotherapy and autologous stem cell transplantation due to other organ dysfunction or comorbidities (especially pulmonary or cardiac), c) follicular lymphoma (fl): pathologically confirmed diagnosis of fl of grade 1, 2, or 3a according to world health organization (who) criteria without pathological evidence of transformation, and relapsed disease after at least two prior systemic therapies including one anti-cd20 containing combination regimen
boolean
C0024305 (UMLS CUI [1,1])
C0449560 (UMLS CUI [1,2])
C0334634 (UMLS CUI [2])
C0677725 (UMLS CUI [3])
C0855138 (UMLS CUI [4])
C0231290 (UMLS CUI [5,1])
C0087111 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C3501358 (UMLS CUI [6])
C1335499 (UMLS CUI [7])
C1744706 (UMLS CUI [8,1])
C3501358 (UMLS CUI [8,2])
C3501358 (UMLS CUI [9,1])
C1444662 (UMLS CUI [9,2])
C0678226 (UMLS CUI [9,3])
C0877248 (UMLS CUI [9,4])
C0079744 (UMLS CUI [10])
C0855111 (UMLS CUI [11])
C0855112 (UMLS CUI [12])
C1512714 (UMLS CUI [13,1])
C1328050 (UMLS CUI [13,2])
C1512714 (UMLS CUI [14,1])
C1831743 (UMLS CUI [14,2])
C0015127 (UMLS CUI [15,1])
C0349410 (UMLS CUI [15,2])
C0015127 (UMLS CUI [16,1])
C0009488 (UMLS CUI [16,2])
C0015127 (UMLS CUI [17,1])
C0009488 (UMLS CUI [17,2])
C0024109 (UMLS CUI [17,3])
C0015127 (UMLS CUI [18,1])
C0009488 (UMLS CUI [18,2])
C0018787 (UMLS CUI [18,3])
C0024301 (UMLS CUI [19,1])
C1301142 (UMLS CUI [19,2])
C0040682 (UMLS CUI [20,1])
C0332197 (UMLS CUI [20,2])
C1335701 (UMLS CUI [21])
C0231290 (UMLS CUI [22,1])
C1515119 (UMLS CUI [22,2])
C1265611 (UMLS CUI [22,3])
C0231290 (UMLS CUI [23,1])
C0009429 (UMLS CUI [23,2])
C0332256 (UMLS CUI [23,3])
C3891557 (UMLS CUI [23,4])
Measurable Disease Site Quantity
Item
at least 1 measurable site of disease
boolean
C1513041 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Tumor tissue sample CD38 Gene Expression Immunohistochemistry | Tumor Cell positive for CD38 antigen Percentage
Item
expression of cd38 by immunohistochemistry on fresh or archived tumor sample by central assessment: a) stage 1: participants whose tumors are more than or equal to (>=) 50 percent (%) positive for cd38, b) stage 2: participants whose tumors are >=1% positive for cd38
boolean
C0475358 (UMLS CUI [1,1])
C1413221 (UMLS CUI [1,2])
C0017262 (UMLS CUI [1,3])
C0021044 (UMLS CUI [1,4])
C0027651 (UMLS CUI [2,1])
C0945928 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
ECOG performance status
Item
participant must have an ecog performance status score of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Sexual Abstinence Heterosexual | Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Gender Partner in relationship Childbearing Potential | Gender Sexually active Condom use | Gender Sperm donation Absent
Item
women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. a woman of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to cycle 1 day 1. a man who is sexually active with a woman of childbearing potential must agree to always use condom during sexual intercourse, and all men must also not donate sperm during the study and for 4 months after receiving the last dose of study drug
boolean
C3831118 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C0019421 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0430057 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5,1])
C0682323 (UMLS CUI [5,2])
C3831118 (UMLS CUI [5,3])
C0079399 (UMLS CUI [6,1])
C0241028 (UMLS CUI [6,2])
C0679782 (UMLS CUI [6,3])
C0079399 (UMLS CUI [7,1])
C0871414 (UMLS CUI [7,2])
C0332197 (UMLS CUI [7,3])
Central nervous system lymphoma
Item
known central nervous system lymphoma
boolean
C0742472 (UMLS CUI [1])
Cancer treatment | Nitrosoureas | Chemotherapy | Antibody therapy | Radioimmunoconjugates | Toxin Immunoconjugates | Therapeutic radiology procedure | Investigational New Drugs
Item
prior anti-tumor therapy including (all times measured prior to start of study drug): nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 2 weeks, investigational agents within 3 weeks, unless antibody this should be within 4 weeks
boolean
C0920425 (UMLS CUI [1])
C0028210 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0281176 (UMLS CUI [4])
C0243019 (UMLS CUI [5])
C0040549 (UMLS CUI [6,1])
C0243020 (UMLS CUI [6,2])
C1522449 (UMLS CUI [7])
C0013230 (UMLS CUI [8])
daratumumab | Therapy Against CD38
Item
daratumumab or other anti-cd38 therapies
boolean
C2346801 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0521124 (UMLS CUI [2,2])
C0075742 (UMLS CUI [2,3])
Malignant Neoplasms | Exception Non-Hodgkin Lymphoma | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Invasive carcinoma of urinary bladder | Exception Papillary neoplasm of low malignant potential | Exception Primary tumor Non-invasive | Exception Malignant Neoplasm Cured | Exception Minimal Risk Recurrence
Item
participant has a history of malignancy (other than nhl) within 5 years before the screening period (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, non-muscle invasive bladder cancer (papillary neoplasms of low malignant potential and primary non-invasive tumors), or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0024305 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C1827293 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0476073 (UMLS CUI [7,2])
C0154129 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0677930 (UMLS CUI [8,2])
C0205303 (UMLS CUI [8,3])
C1705847 (UMLS CUI [9,1])
C0006826 (UMLS CUI [9,2])
C1880198 (UMLS CUI [9,3])
C1705847 (UMLS CUI [10,1])
C4528387 (UMLS CUI [10,2])
C0034897 (UMLS CUI [10,3])
Chronic Obstructive Airway Disease | Percent predicted FEV1 | Moderate persistent asthma | Severe persistent asthma | Asthma Uncontrolled | Intermittent asthma Controlled allowed | Mild persistent asthma Controlled allowed
Item
participant has known chronic obstructive pulmonary disease (copd) with a forced expiratory volume in 1 second (fev1) less than (<) 50% predicted normal. note that fev1 testing is required for patients suspected of having copd and participants must be excluded if fev1 <50% b) participant has known moderate or severe persistent asthma within 2 years (see attachment 4: nhlbi table of asthma severity), or currently has uncontrolled asthma of any classification. (note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study)
boolean
C0024117 (UMLS CUI [1])
C0730561 (UMLS CUI [2])
C1960047 (UMLS CUI [3])
C1960048 (UMLS CUI [4])
C0004096 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C1740754 (UMLS CUI [6,1])
C2911690 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
C1960046 (UMLS CUI [7,1])
C2911690 (UMLS CUI [7,2])
C0683607 (UMLS CUI [7,3])