B-cell lymphoma recurrent | B-cell lymphoma refractory | Mantle cell lymphoma Untreated
Item
1. patients with any type of relapsed or refractory b-cell lymphoma will be eligible in groups a and b (during the dose escalation and the expansion parts of the study) and untreated patients with mantle cell lymphoma will be eligible for group c (only during the expansion part of the study)
boolean
C0855089 (UMLS CUI [1])
C0855090 (UMLS CUI [2])
C0334634 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
Informed Consent | Informed Consent Patient Representative
Item
2. each patient (or their legally acceptable representative) must sign an informed consent form (icf) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Patients Eligible Transplantation of autologous hematopoietic stem cell
Item
3. patients eligible for autologous stem cell transplantation (asct) for whom r-dhap or r-dhaox is an acceptable therapy regarding the investigator's opinion
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C1831743 (UMLS CUI [1,3])
Measurable Disease | Node Lesion Single | Tumor Lesion | Lesion size Quantity
Item
4. measurable disease defined by at least one single node or tumor lesion > 1.5 cm
boolean
C1513041 (UMLS CUI [1])
C0024204 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
C0027651 (UMLS CUI [3,1])
C0221198 (UMLS CUI [3,2])
C0449453 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Prior Therapy Quantity B-Cell Lymphoma
Item
5. patients who received prior therapy with at least one but no more than two lines therapies for b-cell lymphoma (except for patients included in group c during the expansion part of the study)
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0079731 (UMLS CUI [1,3])
Age
Item
6. aged between 18 years and 70 years (included)
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
7. eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Hematology Result
Item
8. any of the following hematology values within 14 days prior to inclusion and prior to the first dose of study drug :
boolean
C0200627 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Absolute neutrophil count | Exception Bone marrow infiltration Due to Lymphoma
Item
1. absolute neutrophil count (anc) > 1,000 cells/mm3 (1.0 x 109/l) unless if bone marrow infiltration from lymphoma
boolean
C0948762 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C3854434 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0024299 (UMLS CUI [2,4])
Platelet Count measurement Spontaneous | Platelet Transfusion | Relationship Bone marrow infiltration Due to Lymphoma
Item
2. spontaneous platelets count > 75,000 cells/mm3 (75 x 109/l) within 7 days of any platelet transfusion (allowed up to 50 x 109/l if due to bone marrow infiltration from lymphoma)
boolean
C0032181 (UMLS CUI [1,1])
C0205359 (UMLS CUI [1,2])
C0086818 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C3854434 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C0024299 (UMLS CUI [3,4])
Other Coding
Item
9. patients assessed as being able to receive full doses of r-dha(p/ox) for 3 cycles or 4 cycles for patients included in group c of the expansion phase
boolean
C3846158 (UMLS CUI [1])
Life Expectancy
Item
10. life expectancy of ≥ 90 days (3 months)
boolean
C0023671 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Gender Sexually active Contraceptive methods | Gender Sperm donation Absent
Item
11. women of childbearing potential* and men who are sexually active must be practicing a highly effective method of birth control during the study and during 12 months after the end of treatments. men must agree to not donate sperm during the study and during 12 months after the end of treatments
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0871414 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Urine pregnancy test negative
Item
12. women of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hcg) or urine pregnancy test at screening
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
BTK Inhibitor
Item
1. previous treatment with a btk inhibitor
boolean
C4086017 (UMLS CUI [1])
Phosphatidylinositide 3-Kinase Inhibitor | Disease Progression | Refractory Disease
Item
2. patients who progressed or became refractory while on treatment with a phosphoinositide 3-kinase (pi3k) inhibitors
boolean
C1519050 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
C1514815 (UMLS CUI [3])
Intolerance to Ara-C Platinum High dose
Item
3. inability to tolerate 4 courses of high dose ara-c / platin compound, especially if due to underlying comorbidities
boolean
C1744706 (UMLS CUI [1,1])
C0733521 (UMLS CUI [1,2])
C0032207 (UMLS CUI [1,3])
C0444956 (UMLS CUI [1,4])
Cerebrovascular accident | Intracranial Hemorrhages
Item
4. history of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug
boolean
C0038454 (UMLS CUI [1])
C0151699 (UMLS CUI [2])
Major surgery
Item
5. major surgery, within 4 weeks prior to the first dose of study drug
boolean
C0679637 (UMLS CUI [1])
Bleeding tendency
Item
6. known bleeding diathesis
boolean
C1458140 (UMLS CUI [1])
Condition Requirement Anticoagulation Therapy | Condition Requirement Vitamin K antagonists
Item
7. condition that requires therapeutic anticoagulation with vitamin k antagonists
boolean
C0348080 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003281 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C3653316 (UMLS CUI [2,3])
Condition Requirement CYP3A4 Inhibitor | Condition Requirement CYP3A5 Inhibitors
Item
8. condition that requires treatment with a strong cytochrome p450 3a4/5 (cyp3a4/5) inhibitor
boolean
C0348080 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3830624 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C3850054 (UMLS CUI [2,3])
Life threatening illness compromises Patient safety | Medical condition Serious compromises Patient safety | Laboratory test result abnormal compromises Patient safety | Organ system Dysfunction compromises Patient safety | Mental disorders compromise Patient safety | Life threatening illness Interferes with Absorption Ibrutinib Capsule | Medical condition Serious Interferes with Absorption Ibrutinib Capsule | Laboratory test result abnormal Interferes with Absorption Ibrutinib Capsule | Organ system Dysfunction Interferes with Absorption Ibrutinib Capsule | Mental disorders Interfere with Absorption Ibrutinib Capsule | Life threatening illness Interferes with Metabolism Ibrutinib Capsule | Medical condition Serious Interferes with Metabolism Ibrutinib Capsule | Laboratory test result abnormal Interferes with Metabolism Ibrutinib Capsule | Organ system Dysfunction Interferes with Metabolism Ibrutinib Capsule | Mental disorders Interfere with Metabolism Ibrutinib Capsule | Life threatening illness At risk Research results | Medical condition Serious At risk Research results | Laboratory test result abnormal At risk Research results | Organ system Dysfunction At risk Research results | Mental disorders At risk Research results | Life threatening illness Preventing Informed Consent | Medical condition Serious Preventing Informed Consent | Laboratory test result abnormal Preventing Informed Consent | Organ system Dysfunction Preventing Informed Consent | Mental disorders Preventing Informed Consent
Item
9. any life-threatening illness, serious medical condition, laboratory abnormality, organ system dysfunction or psychiatric illness which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk and that would prevent the patient from signing the informed consent form
boolean
C3846017 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C1113679 (UMLS CUI [2,4])
C0438215 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C0460002 (UMLS CUI [4,1])
C3887504 (UMLS CUI [4,2])
C2945640 (UMLS CUI [4,3])
C1113679 (UMLS CUI [4,4])
C0004936 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
C3846017 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0237442 (UMLS CUI [6,3])
C3692991 (UMLS CUI [6,4])
C3843040 (UMLS CUI [7,1])
C0205404 (UMLS CUI [7,2])
C0521102 (UMLS CUI [7,3])
C0237442 (UMLS CUI [7,4])
C3692991 (UMLS CUI [7,5])
C0438215 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0237442 (UMLS CUI [8,3])
C3692991 (UMLS CUI [8,4])
C0460002 (UMLS CUI [9,1])
C3887504 (UMLS CUI [9,2])
C0521102 (UMLS CUI [9,3])
C0237442 (UMLS CUI [9,4])
C3692991 (UMLS CUI [9,5])
C0004936 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C0237442 (UMLS CUI [10,3])
C3692991 (UMLS CUI [10,4])
C3846017 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0025520 (UMLS CUI [11,3])
C3692991 (UMLS CUI [11,4])
C3843040 (UMLS CUI [12,1])
C0205404 (UMLS CUI [12,2])
C0521102 (UMLS CUI [12,3])
C0025520 (UMLS CUI [12,4])
C3692991 (UMLS CUI [12,5])
C0438215 (UMLS CUI [13,1])
C0521102 (UMLS CUI [13,2])
C0025520 (UMLS CUI [13,3])
C3692991 (UMLS CUI [13,4])
C0460002 (UMLS CUI [14,1])
C3887504 (UMLS CUI [14,2])
C0521102 (UMLS CUI [14,3])
C0025520 (UMLS CUI [14,4])
C3692991 (UMLS CUI [14,5])
C0004936 (UMLS CUI [15,1])
C0521102 (UMLS CUI [15,2])
C0025520 (UMLS CUI [15,3])
C3692991 (UMLS CUI [15,4])
C3846017 (UMLS CUI [16,1])
C1444641 (UMLS CUI [16,2])
C0683954 (UMLS CUI [16,3])
C3843040 (UMLS CUI [17,1])
C0205404 (UMLS CUI [17,2])
C1444641 (UMLS CUI [17,3])
C0683954 (UMLS CUI [17,4])
C0438215 (UMLS CUI [18,1])
C1444641 (UMLS CUI [18,2])
C0683954 (UMLS CUI [18,3])
C0460002 (UMLS CUI [19,1])
C3887504 (UMLS CUI [19,2])
C1444641 (UMLS CUI [19,3])
C0683954 (UMLS CUI [19,4])
C0004936 (UMLS CUI [20,1])
C1444641 (UMLS CUI [20,2])
C0683954 (UMLS CUI [20,3])
C3846017 (UMLS CUI [21,1])
C1292733 (UMLS CUI [21,2])
C0021430 (UMLS CUI [21,3])
C3843040 (UMLS CUI [22,1])
C0205404 (UMLS CUI [22,2])
C1292733 (UMLS CUI [22,3])
C0021430 (UMLS CUI [22,4])
C0438215 (UMLS CUI [23,1])
C1292733 (UMLS CUI [23,2])
C0021430 (UMLS CUI [23,3])
C0460002 (UMLS CUI [24,1])
C3887504 (UMLS CUI [24,2])
C1292733 (UMLS CUI [24,3])
C0021430 (UMLS CUI [24,4])
C0004936 (UMLS CUI [25,1])
C1292733 (UMLS CUI [25,2])
C0021430 (UMLS CUI [25,3])
Central Nervous System Involvement Lymphoma | Meninges Involvement with Lymphoma
Item
10. known central nervous system or meningeal involvement by lymphoma
boolean
C4050309 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
C0025285 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0024299 (UMLS CUI [2,3])
Medical contraindication Investigational New Drugs
Item
11. contraindication to any drug contained in these regimen
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
HIV Infection
Item
12. known history of human immunodeficiency virus (hiv)
boolean
C0019693 (UMLS CUI [1])
Hepatitis C | RNA Polymerase chain reaction positive | Hepatitis B | Hepatitis B surface antigen positive | DNA Polymerase chain reaction positive | Sepsis Uncontrolled | Requirement Antibiotics Intravenous
Item
13. known active hepatitis c virus (hcv; rna polymerase chain reaction (pcr)-positive) or active hepatitis b virus infection (hbs ag positive or dna pcr-positive) or any uncontrolled active systemic infection requiring intravenous (iv) antibiotics. patients with pcr-negative for hepatitis b virus (hbv) are permitted in the study.
boolean
C0019196 (UMLS CUI [1])
C0035668 (UMLS CUI [2,1])
C3888499 (UMLS CUI [2,2])
C0019163 (UMLS CUI [3])
C0149709 (UMLS CUI [4])
C0012854 (UMLS CUI [5,1])
C3888499 (UMLS CUI [5,2])
C0243026 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C1514873 (UMLS CUI [7,1])
C0003232 (UMLS CUI [7,2])
C1522726 (UMLS CUI [7,3])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction Multiple gated acquisition scanning
Item
14. left ventricular ejection fraction (lvef) < 45% as determined by echocardiography or multiple uptake gated acquisition (muga) scan
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Cardiovascular Disease | Cardiac Arrhythmia Uncontrolled | ARRHYTHMIA SYMPTOMATIC | Congestive heart failure | Myocardial Infarction | Heart Disease New York Heart Association Classification
Item
15. clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months prior to the first dose of study drug, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the new york heart association functional classification
boolean
C0007222 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0741212 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0018799 (UMLS CUI [6,1])
C1275491 (UMLS CUI [6,2])
Result Biochemical
Item
16. any of the following biochemical values within 14 days prior to inclusion and prior to the first dose of study drug :
boolean
C1274040 (UMLS CUI [1,1])
C0205474 (UMLS CUI [1,2])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
1. serum glutamic-oxaloacetic transaminase/aspartate aminotransferase (sgot/asat) or serum glutamic-pyruvic transaminase/alanine aminotransferase (sgpt/alat) > 3.0 x upper limit of normal (uln)
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Serum total bilirubin measurement | Exception Hemolytic Anemia | Exception Gilbert Disease
Item
2. serum total bilirubin > 2.0 mg/dl (34 µmol/l), except in patients with hemolytic anemia or with gilbert syndrome,
boolean
C1278039 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0002878 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0017551 (UMLS CUI [3,2])
Estimation of creatinine clearance by Cockcroft-Gault formula | DHAOx protocol | DHAP protocol
Item
3. calculated creatinine clearance of < 50 ml /min (for patients who will have dhaox chemotherapy) or < 70 ml/min (for patients who will have dhap chemotherapy)
boolean
C2711451 (UMLS CUI [1])
C1121570 (UMLS CUI [2])
C0057634 (UMLS CUI [3])
Neuropathy Pre-existing CTCAE Grades
Item
17. patients with pre-existing ≥ grade 2 neuropathy
boolean
C0442874 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Malignant Neoplasms Except Lymphoma | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Exception Disease Free of Duration
Item
18. prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the patient has been free of the disease for ≥ 3 years
boolean
C0006826 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0686288 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
C0332296 (UMLS CUI [6,3])
C0449238 (UMLS CUI [6,4])
Pharmacotherapy Standard Against Malignant Neoplasms | Pharmacotherapy Investigational Against Malignant Neoplasms
Item
19. use of any standard or experimental anti-cancer drug therapy within 28 days prior to the first dose of study drug
boolean
C0013216 (UMLS CUI [1,1])
C1442989 (UMLS CUI [1,2])
C0521124 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
C0013216 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0521124 (UMLS CUI [2,3])
C0006826 (UMLS CUI [2,4])
Pregnancy | Breast Feeding
Item
20. women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])