0 Ratings
ID

31535

Description

This Trial is a Safety and Feasibility Study of Combination of State of the Art Chemoimmunotherapy, Intensive Central Nervous System Prophylaxis and Scrotal Irradiation to Treat Primary Testicular Diffuse Large B-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00945724

Link

https://clinicaltrials.gov/show/NCT00945724

Keywords

Versions (1)
  1. 9/2/18 9/2/18 -
Copyright Holder

See clinicaltrials.gov

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September 2, 2018

DOI

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License

Creative Commons BY 4.0
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    Eligibility Primary Testicular Diffuse Large B-cell Lymphoma NCT00945724

    English

    Eligibility Primary Testicular Diffuse Large B-cell Lymphoma NCT00945724

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. patients with primary testicular lymphoma at diagnosis. histological subtype included into the study is only diffuse large b cell lymphoma (attachment 2: who classification of lymphoma).
    Description

    Primary testicular lymphoma | Diffuse Large B-Cell Lymphoma WHO tumor classification

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0349644
    UMLS CUI [2,1]
    C0079744
    UMLS CUI [2,2]
    C1301142
    2. orchiectomy is mandatory, before enrolment of the patient into the study.
    Description

    Orchiectomy mandatory

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0029189
    UMLS CUI [1,2]
    C1514873
    3. orchiectomy should be performed within 2 months before study entry.
    Description

    Orchiectomy Recently

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0029189
    UMLS CUI [1,2]
    C0332185
    4. age 18-80
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    5. untreated patients
    Description

    Patients untreated

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C0332155
    6. ann arbor stage ie and iie. bilateral testicular involvement at presentation will not be considered stage iv. these patients may be included into the study and the final ann arbor stage (i or ii) will be determined by the extent of nodal disease.
    Description

    Ann Arbor lymphoma staging system | Testicular Involvement Bilateral

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0432516
    UMLS CUI [2,1]
    C4053942
    UMLS CUI [2,2]
    C0238767
    7. bidimensionally measurable or evaluable disease. patients who have had all disease removed by surgery are eligible.
    Description

    Measurable Disease 2-Dimensional | Evaluable Disease | Excision Disease All

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C1705052
    UMLS CUI [2]
    C1516986
    UMLS CUI [3,1]
    C0728940
    UMLS CUI [3,2]
    C0012634
    UMLS CUI [3,3]
    C0444868
    8. adequate haematological counts: anc > 1.0 x 109/l and plts count > 75 x 109/l
    Description

    Hematologic function | Absolute neutrophil count | Platelet Count measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0221130
    UMLS CUI [2]
    C0948762
    UMLS CUI [3]
    C0032181
    9. cardiac ejection fraction ≥ 45% by muga scan or echocardiography
    Description

    Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0232174
    UMLS CUI [1,2]
    C0521317
    UMLS CUI [2,1]
    C0232174
    UMLS CUI [2,2]
    C0013516
    10. non peripheral neuropathy or any active non-neoplastic cns disease.
    Description

    Neuropathy | Exception Peripheral Neuropathy | Non-Neoplastic Central Nervous System Disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0442874
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0031117
    UMLS CUI [3]
    C1335000
    11. no other major life-threatening illnesses that may preclude chemotherapy
    Description

    Life threatening illness Absent | Life threatening illness Excludes Chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3846017
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [2,1]
    C3846017
    UMLS CUI [2,2]
    C0332196
    UMLS CUI [2,3]
    C0392920
    12. conjugated bilirubin ≤ 2 x uln.
    Description

    Serum conjugated bilirubin measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1278038
    13. alkaline phosphatase and transaminases ≤ 2 x uln.
    Description

    Alkaline phosphatase measurement | Transaminase Assay

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201850
    UMLS CUI [2]
    C0919834
    14. creatinine clearances ≥ 45 ml/min.
    Description

    Creatinine clearance measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0373595
    15. hiv negativity
    Description

    HIV negative

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0481430
    16. hbv negativity or patients with hbvcab +, hbsag -, hbs ab+/- with hbv-dna negative
    Description

    Hepatitis B Virus Negative | HBcAb Positive | Hepatitis B surface antigen negative | Hepatitis B Virus Surface Antibody Positive | Hepatitis B Virus Surface Antibody Negative | Hbv DNA Test Negative

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019169
    UMLS CUI [1,2]
    C1513916
    UMLS CUI [2,1]
    C3702086
    UMLS CUI [2,2]
    C1514241
    UMLS CUI [3]
    C0919711
    UMLS CUI [4,1]
    C0369334
    UMLS CUI [4,2]
    C1514241
    UMLS CUI [5,1]
    C0369334
    UMLS CUI [5,2]
    C1513916
    UMLS CUI [6,1]
    C1256114
    UMLS CUI [6,2]
    C1513916
    17. hcv negativity with the exception of patients with no signs of active chronic hepatitis histologically confirmed
    Description

    Hepatitis C virus Negative | Exception Absence Signs Chronic Hepatitis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0220847
    UMLS CUI [1,2]
    C1513916
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0332197
    UMLS CUI [2,3]
    C0311392
    UMLS CUI [2,4]
    C0019189
    18. life expectancy > 6 months.
    Description

    Life Expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    19. performance status < 2 according to ecog scale.
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    20. no psychiatric illness that precludes understanding concepts of the trial or signing informed consent
    Description

    Mental disorders Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0004936
    UMLS CUI [1,2]
    C0332197
    21. written informed consent
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. has known or suspected hypersensitivity or intolerance to rituximab
    Description

    Hypersensitivity Rituximab | Intolerance to Rituximab | Hypersensitivity Suspected Rituximab | Intolerance Suspected Rituximab

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0393022
    UMLS CUI [2,1]
    C1744706
    UMLS CUI [2,2]
    C0393022
    UMLS CUI [3,1]
    C0020517
    UMLS CUI [3,2]
    C0750491
    UMLS CUI [3,3]
    C0393022
    UMLS CUI [4,1]
    C1744706
    UMLS CUI [4,2]
    C0750491
    UMLS CUI [4,3]
    C0393022
    2. history of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
    Description

    Hepatic Insufficiency | Renal Insufficiency | Heart Diseases | Vascular Diseases | Lung diseases | Gastrointestinal Diseases | Endocrine System Diseases | Nervous system disorder | Rheumatism | Hematological Disease | Mental disorders | Metabolic Diseases

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1306571
    UMLS CUI [2]
    C1565489
    UMLS CUI [3]
    C0018799
    UMLS CUI [4]
    C0042373
    UMLS CUI [5]
    C0024115
    UMLS CUI [6]
    C0017178
    UMLS CUI [7]
    C0014130
    UMLS CUI [8]
    C0027765
    UMLS CUI [9]
    C0035435
    UMLS CUI [10]
    C0018939
    UMLS CUI [11]
    C0004936
    UMLS CUI [12]
    C0025517
    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)
    Description

    Diabetic - poor control | Antidiabetics Dose Stable

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0421258
    UMLS CUI [2,1]
    C0935929
    UMLS CUI [2,2]
    C0178602
    UMLS CUI [2,3]
    C0205360
    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
    Description

    Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Disorder of pericardium | Cardiac amyloidosis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007222
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2,1]
    C0007222
    UMLS CUI [2,2]
    C0205082
    UMLS CUI [3]
    C0027051
    UMLS CUI [4,1]
    C0018801
    UMLS CUI [4,2]
    C1275491
    UMLS CUI [5,1]
    C0002962
    UMLS CUI [5,2]
    C0205318
    UMLS CUI [6]
    C0265122
    UMLS CUI [7]
    C0268407
    5. history of clinically relevant hypotension
    Description

    Hypotension

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0020649
    6. cns involvement (meningeal and/or brain involvement by lymphoma)
    Description

    Central Nervous System Involvement | Meninges Involvement with Lymphoma | Brain Involvement with Lymphoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4050309
    UMLS CUI [2,1]
    C0025285
    UMLS CUI [2,2]
    C1314939
    UMLS CUI [2,3]
    C0024299
    UMLS CUI [3,1]
    C0006104
    UMLS CUI [3,2]
    C1314939
    UMLS CUI [3,3]
    C0024299
    7. evolving malignancy within 3 years with the exception of localized non-melanomatous skin cancer
    Description

    Malignant Neoplasms Evolving | Exception Skin carcinoma Localized

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0332253
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0699893
    UMLS CUI [2,3]
    C0392752
    8. hiv positivity
    Description

    HIV Seropositivity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    9. hbv positivity with the exception of patients with hbvcab +, hbsag -, hbs ab+/- with hbv-dna negative
    Description

    Hepatitis B virus test positive | Exception HBcAb Positive | Exception Hepatitis B surface antigen negative | Exception Hepatitis B Virus Surface Antibody Positive | Exception Hepatitis B Virus Surface Antibody Negative | Exception Hbv DNA Test Negative

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2748184
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C3702086
    UMLS CUI [2,3]
    C1514241
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0919711
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0369334
    UMLS CUI [4,3]
    C1514241
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C0369334
    UMLS CUI [5,3]
    C1513916
    UMLS CUI [6,1]
    C1705847
    UMLS CUI [6,2]
    C1256114
    UMLS CUI [6,3]
    C1513916
    10. hcv positivity with the exception of patients with no signs of active chronic hepatitis histologically confirmed
    Description

    Hepatitis C Virus Positive | Exception Absence Signs Chronic Hepatitis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4330254
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0332197
    UMLS CUI [2,3]
    C0311392
    UMLS CUI [2,4]
    C0019189
    11. active opportunistic infection
    Description

    Opportunistic Infections

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0029118
    12. receipt of extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy
    Description

    Therapeutic radiology procedure Extensive | Systemic Chemotherapy | Cancer treatment

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1522449
    UMLS CUI [1,2]
    C0205231
    UMLS CUI [2]
    C1883256
    UMLS CUI [3]
    C0920425
    13. exposure to rituximab prior study entry
    Description

    Exposure to Rituximab

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332157
    UMLS CUI [1,2]
    C0393022
    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.
    Description

    Investigational New Drugs | Investigational Medical Device

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    UMLS CUI [2]
    C2346570
    15. any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
    Description

    Comorbidity Study Subject Participation Status Excluded | Comorbidity compromises Informed Consent | Mental condition Study Subject Participation Status Excluded | Mental condition compromises Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C0332196
    UMLS CUI [2,1]
    C0009488
    UMLS CUI [2,2]
    C2945640
    UMLS CUI [2,3]
    C0021430
    UMLS CUI [3,1]
    C3840291
    UMLS CUI [3,2]
    C2348568
    UMLS CUI [3,3]
    C0332196
    UMLS CUI [4,1]
    C3840291
    UMLS CUI [4,2]
    C2945640
    UMLS CUI [4,3]
    C0021430
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    Eligibility Primary Testicular Diffuse Large B-cell Lymphoma NCT00945724

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Primary testicular lymphoma | Diffuse Large B-Cell Lymphoma WHO tumor classification
    Item
    1. patients with primary testicular lymphoma at diagnosis. histological subtype included into the study is only diffuse large b cell lymphoma (attachment 2: who classification of lymphoma).
    boolean
    C0349644 (UMLS CUI [1])
    C0079744 (UMLS CUI [2,1])
    C1301142 (UMLS CUI [2,2])
    Orchiectomy mandatory
    Item
    2. orchiectomy is mandatory, before enrolment of the patient into the study.
    boolean
    C0029189 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    Orchiectomy Recently
    Item
    3. orchiectomy should be performed within 2 months before study entry.
    boolean
    C0029189 (UMLS CUI [1,1])
    C0332185 (UMLS CUI [1,2])
    Age
    Item
    4. age 18-80
    boolean
    C0001779 (UMLS CUI [1])
    Patients untreated
    Item
    5. untreated patients
    boolean
    C0030705 (UMLS CUI [1,1])
    C0332155 (UMLS CUI [1,2])
    Ann Arbor lymphoma staging system | Testicular Involvement Bilateral
    Item
    6. ann arbor stage ie and iie. bilateral testicular involvement at presentation will not be considered stage iv. these patients may be included into the study and the final ann arbor stage (i or ii) will be determined by the extent of nodal disease.
    boolean
    C0432516 (UMLS CUI [1])
    C4053942 (UMLS CUI [2,1])
    C0238767 (UMLS CUI [2,2])
    Measurable Disease 2-Dimensional | Evaluable Disease | Excision Disease All
    Item
    7. bidimensionally measurable or evaluable disease. patients who have had all disease removed by surgery are eligible.
    boolean
    C1513041 (UMLS CUI [1,1])
    C1705052 (UMLS CUI [1,2])
    C1516986 (UMLS CUI [2])
    C0728940 (UMLS CUI [3,1])
    C0012634 (UMLS CUI [3,2])
    C0444868 (UMLS CUI [3,3])
    Hematologic function | Absolute neutrophil count | Platelet Count measurement
    Item
    8. adequate haematological counts: anc > 1.0 x 109/l and plts count > 75 x 109/l
    boolean
    C0221130 (UMLS CUI [1])
    C0948762 (UMLS CUI [2])
    C0032181 (UMLS CUI [3])
    Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography
    Item
    9. cardiac ejection fraction ≥ 45% by muga scan or echocardiography
    boolean
    C0232174 (UMLS CUI [1,1])
    C0521317 (UMLS CUI [1,2])
    C0232174 (UMLS CUI [2,1])
    C0013516 (UMLS CUI [2,2])
    Neuropathy | Exception Peripheral Neuropathy | Non-Neoplastic Central Nervous System Disorder
    Item
    10. non peripheral neuropathy or any active non-neoplastic cns disease.
    boolean
    C0442874 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0031117 (UMLS CUI [2,2])
    C1335000 (UMLS CUI [3])
    Life threatening illness Absent | Life threatening illness Excludes Chemotherapy
    Item
    11. no other major life-threatening illnesses that may preclude chemotherapy
    boolean
    C3846017 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C3846017 (UMLS CUI [2,1])
    C0332196 (UMLS CUI [2,2])
    C0392920 (UMLS CUI [2,3])
    Serum conjugated bilirubin measurement
    Item
    12. conjugated bilirubin ≤ 2 x uln.
    boolean
    C1278038 (UMLS CUI [1])
    Alkaline phosphatase measurement | Transaminase Assay
    Item
    13. alkaline phosphatase and transaminases ≤ 2 x uln.
    boolean
    C0201850 (UMLS CUI [1])
    C0919834 (UMLS CUI [2])
    Creatinine clearance measurement
    Item
    14. creatinine clearances ≥ 45 ml/min.
    boolean
    C0373595 (UMLS CUI [1])
    HIV negative
    Item
    15. hiv negativity
    boolean
    C0481430 (UMLS CUI [1])
    Hepatitis B Virus Negative | HBcAb Positive | Hepatitis B surface antigen negative | Hepatitis B Virus Surface Antibody Positive | Hepatitis B Virus Surface Antibody Negative | Hbv DNA Test Negative
    Item
    16. hbv negativity or patients with hbvcab +, hbsag -, hbs ab+/- with hbv-dna negative
    boolean
    C0019169 (UMLS CUI [1,1])
    C1513916 (UMLS CUI [1,2])
    C3702086 (UMLS CUI [2,1])
    C1514241 (UMLS CUI [2,2])
    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 Negative | Exception Absence Signs Chronic Hepatitis
    Item
    17. hcv negativity with the exception of patients with no signs of active chronic hepatitis histologically confirmed
    boolean
    C0220847 (UMLS CUI [1,1])
    C1513916 (UMLS CUI [1,2])
    C1705847 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    C0311392 (UMLS CUI [2,3])
    C0019189 (UMLS CUI [2,4])
    Life Expectancy
    Item
    18. life expectancy > 6 months.
    boolean
    C0023671 (UMLS CUI [1])
    ECOG performance status
    Item
    19. performance status < 2 according to ecog scale.
    boolean
    C1520224 (UMLS CUI [1])
    Mental disorders Absent
    Item
    20. no psychiatric illness that precludes understanding concepts of the trial or signing informed consent
    boolean
    C0004936 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    Informed Consent
    Item
    21. written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Hypersensitivity Rituximab | Intolerance to Rituximab | Hypersensitivity Suspected Rituximab | Intolerance Suspected Rituximab
    Item
    1. has known or suspected hypersensitivity or intolerance to rituximab
    boolean
    C0020517 (UMLS CUI [1,1])
    C0393022 (UMLS CUI [1,2])
    C1744706 (UMLS CUI [2,1])
    C0393022 (UMLS CUI [2,2])
    C0020517 (UMLS CUI [3,1])
    C0750491 (UMLS CUI [3,2])
    C0393022 (UMLS CUI [3,3])
    C1744706 (UMLS CUI [4,1])
    C0750491 (UMLS CUI [4,2])
    C0393022 (UMLS CUI [4,3])
    Hepatic Insufficiency | Renal Insufficiency | Heart Diseases | Vascular Diseases | Lung diseases | Gastrointestinal Diseases | Endocrine System Diseases | Nervous system disorder | Rheumatism | 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])
    C0035435 (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 Pectoris Uncontrolled | 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])
    C0002962 (UMLS CUI [5,1])
    C0205318 (UMLS CUI [5,2])
    C0265122 (UMLS CUI [6])
    C0268407 (UMLS CUI [7])
    Hypotension
    Item
    5. history of clinically relevant hypotension
    boolean
    C0020649 (UMLS CUI [1])
    Central Nervous System Involvement | Meninges Involvement with Lymphoma | Brain Involvement with Lymphoma
    Item
    6. cns involvement (meningeal and/or brain involvement by lymphoma)
    boolean
    C4050309 (UMLS CUI [1])
    C0025285 (UMLS CUI [2,1])
    C1314939 (UMLS CUI [2,2])
    C0024299 (UMLS CUI [2,3])
    C0006104 (UMLS CUI [3,1])
    C1314939 (UMLS CUI [3,2])
    C0024299 (UMLS CUI [3,3])
    Malignant Neoplasms Evolving | Exception Skin carcinoma Localized
    Item
    7. evolving malignancy within 3 years with the exception of localized non-melanomatous skin cancer
    boolean
    C0006826 (UMLS CUI [1,1])
    C0332253 (UMLS CUI [1,2])
    C1705847 (UMLS CUI [2,1])
    C0699893 (UMLS CUI [2,2])
    C0392752 (UMLS CUI [2,3])
    HIV Seropositivity
    Item
    8. hiv positivity
    boolean
    C0019699 (UMLS CUI [1])
    Hepatitis B virus test positive | Exception HBcAb Positive | Exception Hepatitis B surface antigen negative | Exception Hepatitis B Virus Surface Antibody Positive | Exception Hepatitis B Virus Surface Antibody Negative | Exception 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])
    C1705847 (UMLS CUI [2,1])
    C3702086 (UMLS CUI [2,2])
    C1514241 (UMLS CUI [2,3])
    C1705847 (UMLS CUI [3,1])
    C0919711 (UMLS CUI [3,2])
    C1705847 (UMLS CUI [4,1])
    C0369334 (UMLS CUI [4,2])
    C1514241 (UMLS CUI [4,3])
    C1705847 (UMLS CUI [5,1])
    C0369334 (UMLS CUI [5,2])
    C1513916 (UMLS CUI [5,3])
    C1705847 (UMLS CUI [6,1])
    C1256114 (UMLS CUI [6,2])
    C1513916 (UMLS CUI [6,3])
    Hepatitis C Virus Positive | Exception Absence Signs Chronic Hepatitis
    Item
    10. hcv positivity with the exception of patients with no signs of active chronic hepatitis histologically confirmed
    boolean
    C4330254 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    C0311392 (UMLS CUI [2,3])
    C0019189 (UMLS CUI [2,4])
    Opportunistic Infections
    Item
    11. active opportunistic infection
    boolean
    C0029118 (UMLS CUI [1])
    Therapeutic radiology procedure Extensive | Systemic Chemotherapy | Cancer treatment
    Item
    12. receipt of extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy
    boolean
    C1522449 (UMLS CUI [1,1])
    C0205231 (UMLS CUI [1,2])
    C1883256 (UMLS CUI [2])
    C0920425 (UMLS CUI [3])
    Exposure to Rituximab
    Item
    13. exposure to rituximab prior study entry
    boolean
    C0332157 (UMLS CUI [1,1])
    C0393022 (UMLS CUI [1,2])
    Investigational New Drugs | Investigational Medical Device
    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])
    Comorbidity Study Subject Participation Status Excluded | Comorbidity compromises Informed Consent | Mental condition Study Subject Participation Status Excluded | 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])
    C0332196 (UMLS CUI [1,3])
    C0009488 (UMLS CUI [2,1])
    C2945640 (UMLS CUI [2,2])
    C0021430 (UMLS CUI [2,3])
    C3840291 (UMLS CUI [3,1])
    C2348568 (UMLS CUI [3,2])
    C0332196 (UMLS CUI [3,3])
    C3840291 (UMLS CUI [4,1])
    C2945640 (UMLS CUI [4,2])
    C0021430 (UMLS CUI [4,3])
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