Mantle cell lymphoma recurrent | Status post Prior Chemotherapy Quantity | Standard of Care Refused
Item
participant must have a diagnosis of mcl that has relapsed after at least one prior chemotherapy regimen or for which the participant has refused standard therapy
boolean
C0677725 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1514457 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C2936643 (UMLS CUI [3,1])
C1705116 (UMLS CUI [3,2])
Measurable Disease | Lymphadenopathy | Organomegaly | Bone Marrow Involvement | Circulating Neoplastic Cells Lymphoma | Lesion Quantity Longest Diameter | Measurable lesion 2-Dimensional
Item
participant has measureable disease defined by lymphadenopathy, organomegaly, bone marrow involvement and/or circulating lymphoma cells. at least one lesion must be > 2 cm in the longest diameter and measurable in 2 perpendicular dimensions
boolean
C1513041 (UMLS CUI [1])
C0497156 (UMLS CUI [2])
C4054315 (UMLS CUI [3])
C1517677 (UMLS CUI [4])
C0027625 (UMLS CUI [5,1])
C0024299 (UMLS CUI [5,2])
C0221198 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0552406 (UMLS CUI [6,3])
C1513041 (UMLS CUI [7,1])
C1705052 (UMLS CUI [7,2])
ECOG performance status
Item
participant has a performance status of 0, 1, or 2 on the eastern cooperative oncology group (ecog) performance scale
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Sexual Abstinence
Item
female participants of child-bearing potential agree to use two approved contraceptive methods or remain abstinent throughout the study
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
Gender Contraceptive methods
Item
male participants agree to use an adequate method of contraception throughout the study
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
History of malignant neoplasm Absent | Exception Cervix carcinoma Special | Exception Skin carcinoma | Exception Prostate carcinoma Special | Exception Curative treatment | Exception Recurrence Absent | Exception Low risk Recurrence
Item
participant has no history of prior cancer except certain cervical, skin, or prostate cancers, or has undergone potentially curative therapy with no recurrence for five years, or is deemed at low risk for recurrence
boolean
C0455471 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0302592 (UMLS CUI [2,2])
C0205555 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0600139 (UMLS CUI [4,2])
C0205555 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0034897 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C5201228 (UMLS CUI [7,2])
C0034897 (UMLS CUI [7,3])
Platelet Transfusion Absent | Red Blood Cell Transfusion Absent | Colony-Stimulating Factor Support Absent
Item
participant has not had any platelet or red blood cell transfusions or colony stimulating factor support during the month prior to treatment
boolean
C0086818 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0086252 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0009392 (UMLS CUI [3,1])
C0344211 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Availability of Tumor tissue sample Formalin-Fixed Paraffin-Embedded
Item
participant has a pre-study diagnostic formalin fixed paraffin-embedded tumor tissue sample available
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C4684951 (UMLS CUI [1,3])
Exclusion Criteria
Item
exclusion criteria :
boolean
C0680251 (UMLS CUI [1])
Chemotherapy | Therapeutic radiology procedure | Biological treatment
Item
participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks of screening
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
Central nervous system lymphoma
Item
participant has a history of central nervous system (cns) lymphoma
boolean
C0280803 (UMLS CUI [1])
Adrenal Cortex Hormones Required
Item
participant requires the use of corticosteroids
boolean
C0001617 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Pregnancy, Planned | Reproduction Planned
Item
participant is pregnant, breastfeeding, or expecting to conceive or father children during the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0035150 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
HIV Seropositivity
Item
participant is known to be human immunodeficiency virus (hiv)-positive
boolean
C0019699 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
participant has a history of hepatitis b or c
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])