informed consent
Item
1. understand and voluntarily sign an informed consent form
boolean
C0021430 (UMLS CUI [1])
protocol compliance
Item
2. able to adhere to the study visit schedule and other protocol requirements
boolean
C0525058 (UMLS CUI [1])
histologic subtype
Item
3. histologic subtypes as follows:
boolean
C0449574 (UMLS CUI [1])
cd20 positive diffuse large b-cell lymphoma
Item
cd20 positive diffuse large b-cell lymphoma
boolean
C0079744 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
cd20 positive follicular grade iiib
Item
cd20 positive follicular grade iiib
boolean
C0024301 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
C3179006 (UMLS CUI [1,3])
age
Item
4. age 60-80
boolean
C0001779 (UMLS CUI [1])
prior therapy, bulky mass or systemic symptoms or compressive disease or rapidly progressive adenopathies, steroids, vincristine
Item
5. untreated patients. in patients with bulky mass or systemic symptoms or compressive disease or rapidly progressive adenopathies a pre-study treatment is allowed with steroids and/or a single dose of vincristine 1.4 mg/mq (max 2) in the seven days prior the start of the study treatment
boolean
C1514463 (UMLS CUI [1])
C3273930 (UMLS CUI [2,1])
C2039684 (UMLS CUI [2,2])
C0332260 (UMLS CUI [2,3])
C0497156 (UMLS CUI [2,4])
C0149783 (UMLS CUI [2,5])
C0042679 (UMLS CUI [2,6])
measurable and/or evaluable disease
Item
6. measurable and/or evaluable disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
ann arbor stage
Item
7. ann arbor stage ii, iii, iv
boolean
C0432516 (UMLS CUI [1])
international prognostic index
Item
8. international prognostic index at low-intermediate, intermediate-high, high risk (2/3/4-5)
boolean
C1512894 (UMLS CUI [1])
ANC, platelet count, bone marrow involvement
Item
9. adequate haematological counts: anc > 1.5 x 109/l and platelet count > 75 x 109/l unless due to bone marrow involvement
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C1517677 (UMLS CUI [3])
conjugated bilirubin
Item
10. conjugated bilirubin up to 2 x unl
boolean
C0201916 (UMLS CUI [1])
alkaline phosphatase, alt, ast
Item
11. alkaline phosphatase and transaminases up to 2 x unl
boolean
C0201850 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
creatinine clearance
Item
12. creatinine clearance > 50 ml/min
boolean
C0373595 (UMLS CUI [1])
HIV
Item
13. hiv negativity
boolean
C0019682 (UMLS CUI [1])
hepatitis c
Item
14. hcv negativity
boolean
C0019196 (UMLS CUI [1])
hbv negativity or patients with hbvcab +, hbsag -, hbs ab+/- with hbv-dna negative
Item
15. hbv negativity or patients with hbvcab +, hbsag -, hbs ab+/- with hbv-dna negative
boolean
C0019163 (UMLS CUI [1,1])
C0201477 (UMLS CUI [1,2])
C0201478 (UMLS CUI [1,3])
C3641250 (UMLS CUI [1,4])
C3272940 (UMLS CUI [1,5])
cardiac ejection fraction, muga scan or echocardiography
Item
16. cardiac ejection fraction (muga scan or echocardiography) > 45%
boolean
C0232174 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,3])
non peripheral neuropathy or cns disease, non testicular lymphoma
Item
17. non peripheral neuropathy or cns disease. non testicular lymphoma
boolean
C0031117 (UMLS CUI [1])
C0007682 (UMLS CUI [2])
C0349644 (UMLS CUI [3])
life expectancy
Item
18. life expectancy > 6 months
boolean
C0023671 (UMLS CUI [1])
ecog
Item
19. performance status < 2 according to ecog scale
boolean
C1520224 (UMLS CUI [1])
comprehensive geriatric assessment, activity of daily living, geriatric syndrome, comorbidity cirs-g scale
Item
20. comprehensive geriatric assessment (cga) as outlined in appendix 15 showing absence of any impairment in activity of daily living (adl), of any condition defining a geriatric syndrome, and of any grade 4 comorbidity or of more than three grade 3 comorbidities according to cirs-g scale
boolean
C0017463 (UMLS CUI [1])
C1290910 (UMLS CUI [2])
C0679383 (UMLS CUI [3])
C0009488 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
prior malignancy, basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast
Item
21. disease free of prior malignancies for ≥ 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
boolean
C2735088 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
C0851140 (UMLS CUI [4])
C0686288 (UMLS CUI [5])
females of childbearing potential, contraceptive methods, sexual abstinence duration
Item
22. females of childbearing potential (fcbp) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: for at least 28 days before starting study drug;while participating in the study; for at least 28 days after discontinuation from the study
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0487529 (UMLS CUI [1,3])
Contraceptive methods, Intrauterine Devices; Contraceptives, Oral, Hormonal; Contraceptive injection; Contraceptive implant; Tubal Ligation; Vasectomy of husband/partner | Contraception, Barrier; Latex condom; Vaginal contraceptive diaphragm (device); Cervical Cap
Item
the two methods of reliable contraception must include one highly effective method (i.e., intrauterine device (iud), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e., latex condom, diaphragm, cervical cap)
boolean
C0700589 (UMLS CUI [1,1])
C0021900 (UMLS CUI [1,2])
C0009907 (UMLS CUI [1,3])
C1656586 (UMLS CUI [1,4])
C1657106 (UMLS CUI [1,5])
C0520483 (UMLS CUI [1,6])
C3840695 (UMLS CUI [1,7])
C0004764 (UMLS CUI [2,1])
C3873750 (UMLS CUI [2,2])
C0042241 (UMLS CUI [2,3])
C0007848 (UMLS CUI [2,4])
patient referral, contraceptive method provider
Item
fcbp must be referred to a qualified provider of contraceptive methods if needed
boolean
C0034927 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1138603 (UMLS CUI [1,3])
lymphoblastic lymphoma
Item
1. lymphoblastic lymphoma
boolean
C0861294 (UMLS CUI [1])
burkitt lymphoma
Item
2. burkitt lymphoma
boolean
C0006413 (UMLS CUI [1])
non hodgkin lymphoma cd 20 negative
Item
3. non hodgkin lymphoma cd 20 negative
boolean
C0024305 (UMLS CUI [1,1])
C0054946 (UMLS CUI [1,2])
C0205160 (UMLS CUI [1,3])
mantle cell lymphoma
Item
4. mantle cell lymphoma
boolean
C0334634 (UMLS CUI [1])
follicular non hodgkin lymphoma, tumor grade
Item
5. follicular non hodgkin lymphoma grade i-ii-iiia
boolean
C0024301 (UMLS CUI [1,1])
C3179006 (UMLS CUI [1,2])
primitive mediastinal diffuse large b cell lymphoma
Item
6. primitive mediastinal diffuse large b cell lymphoma with only mediastinal involvement
boolean
C1292754 (UMLS CUI [1])
international prognostic index
Item
7. international prognostic index at low risk (1)
boolean
C1512894 (UMLS CUI [1])
hypersensitivity rituximab
Item
8. has known or suspected hypersensitivity or intolerance to rituximab
boolean
C0020517 (UMLS CUI [1,1])
C0393022 (UMLS CUI [1,2])
prior malignancy, basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast
Item
9. history of evolutive malignancy within the last 3 years other than squamous cell and basal cell carcinoma of the skin or carcinoma in situ of the cervix or breast
boolean
C2735088 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
C0851140 (UMLS CUI [4])
C0686288 (UMLS CUI [5])
prior radiotherapy, prior chemotherapy, prior other antineoplastic therapy
Item
10. extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy before enrollment within 3 years before the start of treatment
boolean
C0279134 (UMLS CUI [1])
C1514457 (UMLS CUI [2])
C1514463 (UMLS CUI [3,1])
C2346834 (UMLS CUI [3,2])
exposure to rituximab
Item
11. exposure to rituximab prior to study entry
boolean
C0332157 (UMLS CUI [1,1])
C0393022 (UMLS CUI [1,2])
exposure to experimental drug, Study Subject Participation Status
Item
12. have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study
boolean
C0332157 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2])
cns disease, meningeal and/or brain involvement by lymphoma, testicular involvement
Item
13. cns disease (meningeal and/or brain involvement by lymphoma) or testicular involvement
boolean
C0007682 (UMLS CUI [1,1])
C2213017 (UMLS CUI [1,2])
C0240803 (UMLS CUI [1,3])
C0349644 (UMLS CUI [2])
dvt
Item
14. dvt in the last year
boolean
C0149871 (UMLS CUI [1])
liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
Item
15. history of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
C0042373 (UMLS CUI [4])
C0024115 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0014130 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C1328842 (UMLS CUI [9])
C0018939 (UMLS CUI [10])
C0004936 (UMLS CUI [11])
C0746556 (UMLS CUI [12])
uncontrolled diabetes, antidiabetics
Item
16. uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug)
boolean
C0421258 (UMLS CUI [1])
C0935929 (UMLS CUI [2])
cardiovascular disease, myocardial infarction, heart failure, uncontrolled angina, pericardial disease, cardiac amyloidosis
Item
17. uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, new york heart association (nyha) class iii or iv heart failure (attachment 5, nyha classification of cardiac disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
boolean
C0007222 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
C0018802 (UMLS CUI [1,3])
C0002965 (UMLS CUI [1,4])
C0265122 (UMLS CUI [1,5])
C1387310 (UMLS CUI [1,6])
creatinine clearance
Item
18. creatinine clearance < 50 ml/min
boolean
C0373595 (UMLS CUI [1])
major neurological disorders
Item
19. presence of major neurological disorders
boolean
C0205082 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])
hiv
Item
20. hiv positivity
boolean
C0019699 (UMLS CUI [1])
hbv positivity with the exception of patients with hbvcab +, hbsag -, hbs ab+/- with hbv-dna negative
Item
21. hbv positivity with the exception of patients with hbvcab +, hbsag -, hbs ab+/- with hbv-dna negative
boolean
C0019163 (UMLS CUI [1,1])
C0201477 (UMLS CUI [1,2])
C0201478 (UMLS CUI [1,3])
C3641250 (UMLS CUI [1,4])
C3272940 (UMLS CUI [1,5])
hepatitis c
Item
22. hcv positivity
boolean
C0019196 (UMLS CUI [1])
opportunistic infection
Item
23. active opportunistic infection
boolean
C0029118 (UMLS CUI [1])
comprehensive geriatric assessment, activity of daily living, geriatric syndrome, comorbidity cirs-g scale
Item
24. comprehensive geriatric assessment (cga) as outlined in appendix 15 showing presence of any impairment in activity of daily living (adl), of any condition defining a geriatric syndrome, and of any grade 4 comorbidity or of more than three grade 3 comorbidities according to cirs-g scale
boolean
C0017463 (UMLS CUI [1])
C1290910 (UMLS CUI [2])
C0679383 (UMLS CUI [3])
C0009488 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
comorbidity
Item
25. any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])