Non-follicular lymphoma indolent | Mantle cell lymphoma | rituximab | Disease Therapy naive | Disease Therapy Sensitive | Absent response to treatment | Relapse Post First line treatment | Progressive Disease Requirement Additional Therapy | Small Lymphocytic Lymphoma | Monocytoid B-cell lymphoma | MALT Lymphoma Excluded | Splenic Marginal Zone B-Cell Lymphoma | Biopsy of lymph node | Cell transformation Excluded
Item
1. patients with naïve or sensitive rituximab indolent non-follicular and mantle cell non-hodgkin's lymphoma disease that had failed to respond or relapsed after primary therapy. there is a demonstrated progressive disease requiring further treatment. histological subtype included into the study are are as follows small lymphocytic/lymphoplasmocytic lymphoma; nodal marginal zone lymphoma (malt lymphoma are excluded) splenic marginal zone lymphoma mantle cell lymphoma a lymphnode biopsy is advisable if it is not harmful for the patients, before enrollment of the patient into the study in order to confirm diagnosis and to rule out histologic transformation. lymphnode biopsy should be performed within 6 months before study entry.
boolean
C2853945 (UMLS CUI [1,1])
C0234227 (UMLS CUI [1,2])
C0334634 (UMLS CUI [2])
C0393022 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0919936 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C0087111 (UMLS CUI [5,2])
C0332324 (UMLS CUI [5,3])
C0438286 (UMLS CUI [6])
C0277556 (UMLS CUI [7,1])
C0687676 (UMLS CUI [7,2])
C1708063 (UMLS CUI [7,3])
C1335499 (UMLS CUI [8,1])
C1514873 (UMLS CUI [8,2])
C1706712 (UMLS CUI [8,3])
C0855095 (UMLS CUI [9])
C0855139 (UMLS CUI [10])
C0242647 (UMLS CUI [11,1])
C2828389 (UMLS CUI [11,2])
C0349632 (UMLS CUI [12])
C0193842 (UMLS CUI [13])
C0040682 (UMLS CUI [14,1])
C2828389 (UMLS CUI [14,2])
Age
Item
2. age >18-75
boolean
C0001779 (UMLS CUI [1])
Chemotherapy Quantity Absent response to treatment
Item
3. relapse or failure to respond after one or more (maximum three) lines of chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0438286 (UMLS CUI [1,3])
Chemotherapy | rituximab | High-Dose Chemotherapy with Autologous Stem Cell Transplant
Item
4. any type of prior chemotherapy, rituximab included. patients who had received high dose chemotherapy and asct can be enrolled into the study
boolean
C0392920 (UMLS CUI [1])
C0393022 (UMLS CUI [2])
C1512429 (UMLS CUI [3])
rituximab | Disease Therapy naive | Disease Therapy Sensitive | Disease Response | Thrombotic Thrombocytopenic Purpura Duration
Item
5. naïve or sensitive rituximab disease. if the patient received rituximab, he/she must have responded and the ttp from the last dose to rituximab must have been 6 months or more.
boolean
C0393022 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0919936 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0332324 (UMLS CUI [3,3])
C1704632 (UMLS CUI [4])
C0034155 (UMLS CUI [5,1])
C0449238 (UMLS CUI [5,2])
Measurable Disease | Evaluable Disease
Item
6. measurable and/or evaluable disease.
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Hematologic function | Absolute neutrophil count | Platelet Count measurement | Absolute neutrophil count Due to Lymphoma involves bone marrow | Platelet Count Due to Lymphoma involves bone marrow
Item
7. adequate haematological counts: anc> 1.0 x 109/l and plt counts> 75 x 109/l unless due to bone marrow involvement by lymphoma.
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0948762 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C1301440 (UMLS CUI [4,3])
C1287267 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C1301440 (UMLS CUI [5,3])
Bilirubin conjugated increased
Item
8. conjugated bilirubin up to 2 x uln.
boolean
C0855625 (UMLS CUI [1])
Alkaline phosphatase raised | Transaminases increased
Item
9. alkaline phosphatase and transaminases up to 2 x uln.
boolean
C0151849 (UMLS CUI [1])
C0438717 (UMLS CUI [2])
Creatinine measurement, serum
Item
10. creatinine clearances> 30 m/min.
boolean
C0201976 (UMLS CUI [1])
Peripheral Neuropathy Absent | CNS disorder Absent
Item
11. non peripheral neuropathy or cns disease.
boolean
C0031117 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0007682 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Life Expectancy
Item
12. life expectancy> 6 months.
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
13. performance status< 2 according to ecog scale.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
14. written informed consent
boolean
C0021430 (UMLS CUI [1])
Hypersensitivity rituximab | Hypersensitivity Boron | Hypersensitivity Mannitol | Hypersensitivity Heparin | intolerance to rituximab | intolerance to Boron | intolerance to Mannitol | intolerance to Heparin | Indwelling Catheter Use of
Item
1. has known or suspected hypersensitivity or intolerance to rituximab, boron, mannitol, or heparin, if an indwelling catheter is used
boolean
C0020517 (UMLS CUI [1,1])
C0393022 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0006030 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0024730 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0019134 (UMLS CUI [4,2])
C1744706 (UMLS CUI [5,1])
C0393022 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0006030 (UMLS CUI [6,2])
C1744706 (UMLS CUI [7,1])
C0024730 (UMLS CUI [7,2])
C1744706 (UMLS CUI [8,1])
C0019134 (UMLS CUI [8,2])
C0007439 (UMLS CUI [9,1])
C1524063 (UMLS CUI [9,2])
Hepatic Insufficiency | Renal Insufficiency | Heart Diseases | Vascular Diseases | Lung diseases | Gastrointestinal Diseases | Endocrine System Diseases | nervous system disorder | Rheumatologic disorder | Hematological Disease | Mental disorders | Metabolic Diseases
Item
2. history of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
boolean
C1306571 (UMLS CUI [1])
C1565489 (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])
C0009326 (UMLS CUI [9])
C0018939 (UMLS CUI [10])
C0004936 (UMLS CUI [11])
C0025517 (UMLS CUI [12])
Diabetic - poor control | Antidiabetics Dose Stable
Item
3. 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 [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina control - poor | Disorder of pericardium | Cardiac amyloidosis
Item
4. 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])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0018801 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0421196 (UMLS CUI [5])
C0265122 (UMLS CUI [6])
C0268407 (UMLS CUI [7])
Hypotension | Decreased Blood Pressure | Sitting systolic blood pressure | Sitting diastolic blood pressure
Item
5. history of hypotension or has decreased blood pressure (sitting systolic blood pressure sbp 100 mmhg and/or sitting diastolic blood pressure dbp 60 mmhg)
boolean
C0020649 (UMLS CUI [1])
C2917141 (UMLS CUI [2])
C1319893 (UMLS CUI [3])
C1319894 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
6. pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Peripheral Neuropathy CTCAE Grades | Neuropathic pain CTCAE Grades
Item
7. peripheral neuropathy or neuropathic pain grade 2
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C3714625 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
HIV Seropositivity
Item
8. hiv positivity
boolean
C0019699 (UMLS CUI [1])
Hepatitis B virus test positive | Hepatitis B core antibody positive | Hepatitis B surface antigen negative | Hepatitis B Virus Surface Antibody Positive | Hepatitis B Virus Surface Antibody Negative | Hbv DNA Test Negative
Item
9. hbv positivity with the exception of patients with hbvcab +, hbsag -, hbs ab+/- with hbv-dna negative
boolean
C2748184 (UMLS CUI [1])
C0262506 (UMLS CUI [2])
C0919711 (UMLS CUI [3])
C0369334 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0369334 (UMLS CUI [5,1])
C1513916 (UMLS CUI [5,2])
C1256114 (UMLS CUI [6,1])
C1513916 (UMLS CUI [6,2])
Hepatitis C virus test positive | Chronic Hepatitis Signs Absent
Item
10. hcv positivity with the exception of patients with no signs of active chronic hepatitis histologically confirmed
boolean
C2748185 (UMLS CUI [1])
C0019189 (UMLS CUI [2,1])
C0311392 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Opportunistic Infections
Item
11. active opportunistic infection
boolean
C0029118 (UMLS CUI [1])
Extensive Radiation | Systemic Chemotherapy | cancer treatment
Item
12. receipt of extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks before enrollment
boolean
C1517030 (UMLS CUI [1])
C1883256 (UMLS CUI [2])
C0920425 (UMLS CUI [3])
rituximab Exposure to
Item
13. exposure to rituximab within 24 weeks before screening
boolean
C0393022 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
Investigational New Drugs | Investigational Medical Device | Study Subject Participation Status Interference Absent
Item
14. 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
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C2348568 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Comorbidity Study Subject Participation Status Exclusion | Mental condition Study Subject Participation Status Exclusion | Comorbidity compromises Informed Consent | Mental condition compromises Informed Consent
Item
15. any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
C0009488 (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])