Chronic Lymphocytic Leukemia Monoclonal free light chain present CD23 positive | Chronic Lymphocytic Leukemia Monoclonal free light chain present CD5 positive | Chronic Lymphocytic Leukemia Monoclonal free light chain present CD19 positive | Indication Therapeutic procedure
Item
male or female patients with cd23+, cd5+, cd19+ light chain monoclonal b-cll with treatment indication according to iwcll criteria (appendix 4)
boolean
C0023434 (UMLS CUI [1,1])
C1532998 (UMLS CUI [1,2])
C0945924 (UMLS CUI [1,3])
C0023434 (UMLS CUI [2,1])
C1532998 (UMLS CUI [2,2])
C0882892 (UMLS CUI [2,3])
C0023434 (UMLS CUI [3,1])
C1532998 (UMLS CUI [3,2])
C0882808 (UMLS CUI [3,3])
C3146298 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
Relapse Ordinal number | Fludarabine | First line treatment | Refractory Disease | Indication Therapeutic procedure
Item
1st or greater relapse after fludarabine or any other primary treatment regimen or refractory to any previous treatment and simultaneous indication for treatment according to iwcll criteria (appendix 4)
boolean
C0035020 (UMLS CUI [1,1])
C0439080 (UMLS CUI [1,2])
C0059985 (UMLS CUI [2])
C1708063 (UMLS CUI [3])
C1514815 (UMLS CUI [4])
C3146298 (UMLS CUI [5,1])
C0087111 (UMLS CUI [5,2])
Age
Item
age 18 years and older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog status 0 - 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 6 months
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
written informed consent given by the patient
boolean
C0021430 (UMLS CUI [1])
Contraceptive methods | Contraception, Barrier | Oral contraception | Contraceptive Patch | Spermatocidal Agents | Intrauterine Devices | Gender Contraceptive methods | Childbearing Potential Contraceptive methods
Item
patient using a reliable means of contraception (e.g. physical barrier, contraceptive pill or patch, spermicide and barrier, or iud) for the duration of the study. male patients have to use an adequate contraception method for the duration of study treatment and for 6 months following completion of study treatment. women of childbearing potential have to use an effective method of contraception for the duration of study participation.
boolean
C0700589 (UMLS CUI [1])
C0004764 (UMLS CUI [2])
C0029151 (UMLS CUI [3])
C2985284 (UMLS CUI [4])
C0037862 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0079399 (UMLS CUI [7,1])
C0700589 (UMLS CUI [7,2])
C3831118 (UMLS CUI [8,1])
C0700589 (UMLS CUI [8,2])
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
hiv positive or positive for hepatitis b or c
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Communicable Disease Uncontrolled
Item
active uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Humanized Monoclonal Antibodies | Anaphylaxis Humanized Monoclonal Antibodies | Hypersensitivity Excipient Investigational New Drugs | Anaphylaxis Excipient Investigational New Drugs | Hypersensitivity Bendamustine hydrochloride | Anaphylaxis Bendamustine hydrochloride | Mannitol allergy | Anaphylaxis Mannitol
Item
hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or to the excipients of any of the applied drugs (e.g. bendamustine hydrochloride or mannitol)
boolean
C0020517 (UMLS CUI [1,1])
C2985546 (UMLS CUI [1,2])
C0002792 (UMLS CUI [2,1])
C2985546 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0015237 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
C0002792 (UMLS CUI [4,1])
C0015237 (UMLS CUI [4,2])
C0013230 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0772139 (UMLS CUI [5,2])
C0002792 (UMLS CUI [6,1])
C0772139 (UMLS CUI [6,2])
C0571922 (UMLS CUI [7])
C0002792 (UMLS CUI [8,1])
C0024730 (UMLS CUI [8,2])
Prior Therapy Bendamustine
Item
previous treatment with bendamustine
boolean
C1514463 (UMLS CUI [1,1])
C0525079 (UMLS CUI [1,2])
Investigational New Drugs
Item
treatment with an experimental drug within the previous 2 months
boolean
C0013230 (UMLS CUI [1])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Prostate carcinoma Low grade Curative procedure intent | Exception DCIS Lumpectomy
Item
patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis dcis of the breast treated with lumpectomy alone with curative intent.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0600139 (UMLS CUI [5,2])
C1282907 (UMLS CUI [5,3])
C1276305 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0007124 (UMLS CUI [6,2])
C0024885 (UMLS CUI [6,3])
Transformation B cell Aggressive malignancy | Diffuse Large B-Cell Lymphoma | Richter's syndrome | Prolymphocytic Leukemia
Item
transformation to aggressive b-cell malignancy (e.g. large b-cell lymphoma, richter's syndrome, or prolymphocytic leukemia (pll)
boolean
C0040682 (UMLS CUI [1,1])
C0004561 (UMLS CUI [1,2])
C3149729 (UMLS CUI [1,3])
C0079744 (UMLS CUI [2])
C0349631 (UMLS CUI [3])
C0023486 (UMLS CUI [4])
Decreased renal function | Creatinine clearance measurement
Item
decreased kidney function with creatinine clearance < 30 ml/min
boolean
C0232807 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Comorbidity Severe | Dysfunction Organ Major | Liver damage Severe | Icterus
Item
patients with severe co-morbidities or major organ dysfunctions (e.g. known severe liver damage, jaundice)
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3887504 (UMLS CUI [2,1])
C0178784 (UMLS CUI [2,2])
C0205164 (UMLS CUI [2,3])
C0151763 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0022346 (UMLS CUI [4])
Heart Disease Severe | Heart failure New York Heart Association Classification | Myocardial Infarction | Ventricular Tachycardia Treatment required for | Angina, Unstable
Item
patients with a history of severe cardiac disease; e.g. nyha functional class iii or iv heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0042514 (UMLS CUI [4,1])
C0332121 (UMLS CUI [4,2])
C0002965 (UMLS CUI [5])
Medical condition Study Subject Participation Status Excluded | Mental condition Study Subject Participation Status Excluded | Medical condition compromises Informed Consent | Mental condition compromises Informed Consent | Protocol Compliance Unable
Item
any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent, or patients unable to comply with requirements of study protocol
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])
C0525058 (UMLS CUI [5,1])
C1299582 (UMLS CUI [5,2])