Age | High-dose chemotherapy Receive Unable | Autologous stem cell infusion Receive Unable
Item
age over 65 years, or age under 65 years, unable to tolerate high dose chemotherapy with autologous stem cell support
boolean
C0001779 (UMLS CUI [1])
C1328050 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C2145405 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Mantle cell lymphoma Ann Arbor lymphoma staging system
Item
histologically confirmed mantle cell lymphoma, stage ii-iv at time of diagnosis
boolean
C0334634 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
Absence Prior Therapy Lymphoma | Exception Therapeutic radiology procedure Lymphoma | Exception Chemotherapy cycle Quantity Lymphoma
Item
no previous treatment for lymphoma except radiotherapy or one cycle of any chemotherapy regimen for lymphoma
boolean
C0332197 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0024299 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1302181 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0024299 (UMLS CUI [3,4])
WHO performance status scale
Item
who performance status 0-3
boolean
C1298650 (UMLS CUI [1])
Informed Consent
Item
written informed concent
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Relationship Investigational Therapy
Item
female subjects of childbearing potential must agree to use and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, through study drug therapy and for 4 weeks after the end of study drug therapy
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0439849 (UMLS CUI [2,1])
C0949266 (UMLS CUI [2,2])
Gender Male Condom | Partner Childbearing Potential Contraceptive methods Absent | Sperm donation Absent | Relationship Investigational Therapy
Item
male subjects must agree to use condoms throughout study drug therapy if their partner is of childbearing potential, and has no contraception, and agree to not donate semen during study drug therapy and for one week after end of study drug therapy
boolean
C0079399 (UMLS CUI [1,1])
C0009653 (UMLS CUI [1,2])
C0682323 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
C0871414 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0439849 (UMLS CUI [4,1])
C0949266 (UMLS CUI [4,2])
Blood Donation Absent | Investigational New Drugs Sharing Absent | Relationship Investigational Therapy
Item
all subjects must agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation, and agree not to share study medication with another person
boolean
C0005794 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C0237876 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0439849 (UMLS CUI [3,1])
C0949266 (UMLS CUI [3,2])
Liver Dysfunction
Item
impaired liver function
boolean
C0086565 (UMLS CUI [1])
Absolute neutrophil count | Exception Etiology Bone marrow infiltration Lymphoma
Item
anc less than 1.0 x 10 9, unless caused by bone marrow infiltration by lymphoma
boolean
C0948762 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C3854434 (UMLS CUI [2,3])
C0024299 (UMLS CUI [2,4])
Platelet Count measurement | Exception Etiology Bone marrow infiltration Lymphoma
Item
platelet count less than 60 x 10 9, unless caused by bone marrow infiltration by lymphoma
boolean
C0032181 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C3854434 (UMLS CUI [2,3])
C0024299 (UMLS CUI [2,4])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
creatinine clearance below 50 ml/min (cockcroft formula))
boolean
C2711451 (UMLS CUI [1])
HIV Seropositivity
Item
known hiv positivity
boolean
C0019699 (UMLS CUI [1])
Serology positive Hepatitis C virus | Serology positive Hepatitis B Surface Antigens | Serology positive Anti-HBc antibody | Communicable Disease Uncontrolled
Item
known seropositivity for hcv, hbsag, anti-hbc, or other active infection uncontrolled by treatment
boolean
C0242089 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
C0242089 (UMLS CUI [2,1])
C0019168 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0948759 (UMLS CUI [3,2])
C0009450 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Mental disorders Interferes with Comprehension Study Protocol | Mental condition Interferes with Comprehension Study Protocol
Item
psychiatric illness or condition which could interfere with the subject´s ability to understand the requirements of the study
boolean
C0004936 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0162340 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
Patient need for Steroid therapy | Prednisolone Dose U/day
Item
requirement of corticosteroid therapy at a dose over 10 mg prednisolone/day
boolean
C0686904 (UMLS CUI [1,1])
C0149783 (UMLS CUI [1,2])
C0032950 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])