ID

34885

Beschreibung

Bruton's Tyrosine Kinase (BTK) Inhibition in B-cell Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT02055924

Link

https://clinicaltrials.gov/show/NCT02055924

Stichworte

Versionen (1)
  1. 01.02.19 01.02.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

1. Februar 2019

DOI

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Eligibility B-cell Lymphoma NCT02055924

Englisch

Eligibility B-cell Lymphoma NCT02055924

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
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)
Beschreibung

B-cell lymphoma recurrent | B-cell lymphoma refractory | Mantle cell lymphoma Untreated

Datentyp

boolean

Alias
UMLS CUI [1]
C0855089
UMLS CUI [2]
C0855090
UMLS CUI [3,1]
C0334634
UMLS CUI [3,2]
C0332155
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
Beschreibung

Informed Consent | Informed Consent Patient Representative

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
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
Beschreibung

Patients Eligible Transplantation of autologous hematopoietic stem cell

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C1831743
4. measurable disease defined by at least one single node or tumor lesion > 1.5 cm
Beschreibung

Measurable Disease | Node Lesion Single | Tumor Lesion | Lesion size Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0024204
UMLS CUI [2,2]
C0221198
UMLS CUI [2,3]
C0205171
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C0221198
UMLS CUI [4,1]
C0449453
UMLS CUI [4,2]
C1265611
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)
Beschreibung

Prior Therapy Quantity B-Cell Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0079731
6. aged between 18 years and 70 years (included)
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
7. eastern cooperative oncology group (ecog) performance status 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
8. any of the following hematology values within 14 days prior to inclusion and prior to the first dose of study drug :
Beschreibung

Hematology Result

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0200627
UMLS CUI [1,2]
C1274040
1. absolute neutrophil count (anc) > 1,000 cells/mm3 (1.0 x 109/l) unless if bone marrow infiltration from lymphoma
Beschreibung

Absolute neutrophil count | Exception Bone marrow infiltration Due to Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3854434
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0024299
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)
Beschreibung

Platelet Count measurement Spontaneous | Platelet Transfusion | Relationship Bone marrow infiltration Due to Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032181
UMLS CUI [1,2]
C0205359
UMLS CUI [2]
C0086818
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C3854434
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C0024299
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
Beschreibung

Other Coding

Datentyp

boolean

Alias
UMLS CUI [1]
C3846158
10. life expectancy of ≥ 90 days (3 months)
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
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
Beschreibung

Childbearing Potential Contraceptive methods | Gender Sexually active Contraceptive methods | Gender Sperm donation Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0871414
UMLS CUI [3,3]
C0332197
12. women of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hcg) or urine pregnancy test at screening
Beschreibung

Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Urine pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430060
UMLS CUI [1,3]
C1513916
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous treatment with a btk inhibitor
Beschreibung

BTK Inhibitor

Datentyp

boolean

Alias
UMLS CUI [1]
C4086017
2. patients who progressed or became refractory while on treatment with a phosphoinositide 3-kinase (pi3k) inhibitors
Beschreibung

Phosphatidylinositide 3-Kinase Inhibitor | Disease Progression | Refractory Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1519050
UMLS CUI [2]
C0242656
UMLS CUI [3]
C1514815
3. inability to tolerate 4 courses of high dose ara-c / platin compound, especially if due to underlying comorbidities
Beschreibung

Intolerance to Ara-C Platinum High dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0733521
UMLS CUI [1,3]
C0032207
UMLS CUI [1,4]
C0444956
4. history of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug
Beschreibung

Cerebrovascular accident | Intracranial Hemorrhages

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0151699
5. major surgery, within 4 weeks prior to the first dose of study drug
Beschreibung

Major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
6. known bleeding diathesis
Beschreibung

Bleeding tendency

Datentyp

boolean

Alias
UMLS CUI [1]
C1458140
7. condition that requires therapeutic anticoagulation with vitamin k antagonists
Beschreibung

Condition Requirement Anticoagulation Therapy | Condition Requirement Vitamin K antagonists

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003281
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C3653316
8. condition that requires treatment with a strong cytochrome p450 3a4/5 (cyp3a4/5) inhibitor
Beschreibung

Condition Requirement CYP3A4 Inhibitor | Condition Requirement CYP3A5 Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C3830624
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C3850054
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
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3846017
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C2945640
UMLS CUI [2,4]
C1113679
UMLS CUI [3,1]
C0438215
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C1113679
UMLS CUI [4,1]
C0460002
UMLS CUI [4,2]
C3887504
UMLS CUI [4,3]
C2945640
UMLS CUI [4,4]
C1113679
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C2945640
UMLS CUI [5,3]
C1113679
UMLS CUI [6,1]
C3846017
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0237442
UMLS CUI [6,4]
C3692991
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C0205404
UMLS CUI [7,3]
C0521102
UMLS CUI [7,4]
C0237442
UMLS CUI [7,5]
C3692991
UMLS CUI [8,1]
C0438215
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C0237442
UMLS CUI [8,4]
C3692991
UMLS CUI [9,1]
C0460002
UMLS CUI [9,2]
C3887504
UMLS CUI [9,3]
C0521102
UMLS CUI [9,4]
C0237442
UMLS CUI [9,5]
C3692991
UMLS CUI [10,1]
C0004936
UMLS CUI [10,2]
C0521102
UMLS CUI [10,3]
C0237442
UMLS CUI [10,4]
C3692991
UMLS CUI [11,1]
C3846017
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C0025520
UMLS CUI [11,4]
C3692991
UMLS CUI [12,1]
C3843040
UMLS CUI [12,2]
C0205404
UMLS CUI [12,3]
C0521102
UMLS CUI [12,4]
C0025520
UMLS CUI [12,5]
C3692991
UMLS CUI [13,1]
C0438215
UMLS CUI [13,2]
C0521102
UMLS CUI [13,3]
C0025520
UMLS CUI [13,4]
C3692991
UMLS CUI [14,1]
C0460002
UMLS CUI [14,2]
C3887504
UMLS CUI [14,3]
C0521102
UMLS CUI [14,4]
C0025520
UMLS CUI [14,5]
C3692991
UMLS CUI [15,1]
C0004936
UMLS CUI [15,2]
C0521102
UMLS CUI [15,3]
C0025520
UMLS CUI [15,4]
C3692991
UMLS CUI [16,1]
C3846017
UMLS CUI [16,2]
C1444641
UMLS CUI [16,3]
C0683954
UMLS CUI [17,1]
C3843040
UMLS CUI [17,2]
C0205404
UMLS CUI [17,3]
C1444641
UMLS CUI [17,4]
C0683954
UMLS CUI [18,1]
C0438215
UMLS CUI [18,2]
C1444641
UMLS CUI [18,3]
C0683954
UMLS CUI [19,1]
C0460002
UMLS CUI [19,2]
C3887504
UMLS CUI [19,3]
C1444641
UMLS CUI [19,4]
C0683954
UMLS CUI [20,1]
C0004936
UMLS CUI [20,2]
C1444641
UMLS CUI [20,3]
C0683954
UMLS CUI [21,1]
C3846017
UMLS CUI [21,2]
C1292733
UMLS CUI [21,3]
C0021430
UMLS CUI [22,1]
C3843040
UMLS CUI [22,2]
C0205404
UMLS CUI [22,3]
C1292733
UMLS CUI [22,4]
C0021430
UMLS CUI [23,1]
C0438215
UMLS CUI [23,2]
C1292733
UMLS CUI [23,3]
C0021430
UMLS CUI [24,1]
C0460002
UMLS CUI [24,2]
C3887504
UMLS CUI [24,3]
C1292733
UMLS CUI [24,4]
C0021430
UMLS CUI [25,1]
C0004936
UMLS CUI [25,2]
C1292733
UMLS CUI [25,3]
C0021430
10. known central nervous system or meningeal involvement by lymphoma
Beschreibung

Central Nervous System Involvement Lymphoma | Meninges Involvement with Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0024299
UMLS CUI [2,1]
C0025285
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0024299
11. contraindication to any drug contained in these regimen
Beschreibung

Medical contraindication Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
12. known history of human immunodeficiency virus (hiv)
Beschreibung

HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
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.
Beschreibung

Hepatitis C | RNA Polymerase chain reaction positive | Hepatitis B | Hepatitis B surface antigen positive | DNA Polymerase chain reaction positive | Sepsis Uncontrolled | Requirement Antibiotics Intravenous

Datentyp

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2,1]
C0035668
UMLS CUI [2,2]
C3888499
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0149709
UMLS CUI [5,1]
C0012854
UMLS CUI [5,2]
C3888499
UMLS CUI [6,1]
C0243026
UMLS CUI [6,2]
C0205318
UMLS CUI [7,1]
C1514873
UMLS CUI [7,2]
C0003232
UMLS CUI [7,3]
C1522726
14. left ventricular ejection fraction (lvef) < 45% as determined by echocardiography or multiple uptake gated acquisition (muga) scan
Beschreibung

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction Multiple gated acquisition scanning

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0521317
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
Beschreibung

Cardiovascular Disease | Cardiac Arrhythmia Uncontrolled | ARRHYTHMIA SYMPTOMATIC | Congestive heart failure | Myocardial Infarction | Heart Disease New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0741212
UMLS CUI [4]
C0018802
UMLS CUI [5]
C0027051
UMLS CUI [6,1]
C0018799
UMLS CUI [6,2]
C1275491
16. any of the following biochemical values within 14 days prior to inclusion and prior to the first dose of study drug :
Beschreibung

Result Biochemical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0205474
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)
Beschreibung

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
2. serum total bilirubin > 2.0 mg/dl (34 µmol/l), except in patients with hemolytic anemia or with gilbert syndrome,
Beschreibung

Serum total bilirubin measurement | Exception Hemolytic Anemia | Exception Gilbert Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0002878
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0017551
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)
Beschreibung

Estimation of creatinine clearance by Cockcroft-Gault formula | DHAOx protocol | DHAP protocol

Datentyp

boolean

Alias
UMLS CUI [1]
C2711451
UMLS CUI [2]
C1121570
UMLS CUI [3]
C0057634
17. patients with pre-existing ≥ grade 2 neuropathy
Beschreibung

Neuropathy Pre-existing CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
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
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0024299
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0686288
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0012634
UMLS CUI [6,3]
C0332296
UMLS CUI [6,4]
C0449238
19. use of any standard or experimental anti-cancer drug therapy within 28 days prior to the first dose of study drug
Beschreibung

Pharmacotherapy Standard Against Malignant Neoplasms | Pharmacotherapy Investigational Against Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C1442989
UMLS CUI [1,3]
C0521124
UMLS CUI [1,4]
C0006826
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C1517586
UMLS CUI [2,3]
C0521124
UMLS CUI [2,4]
C0006826
20. women who are pregnant or breastfeeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility B-cell Lymphoma NCT02055924

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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