ID

31535

Beschreibung

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

Stichworte

Versionen (1)
  1. 02.09.18 02.09.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

2. September 2018

DOI

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Lizenz

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

Englisch

Eligibility Primary Testicular Diffuse Large B-cell Lymphoma NCT00945724

1 Formulare  
Inclusion Criteria
Beschreibung

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).
Beschreibung

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

Datentyp

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.
Beschreibung

Orchiectomy mandatory

Datentyp

boolean

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

Orchiectomy Recently

Datentyp

boolean

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

Age

Datentyp

boolean

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

Patients untreated

Datentyp

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.
Beschreibung

Ann Arbor lymphoma staging system | Testicular Involvement Bilateral

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Hematologic function | Absolute neutrophil count | Platelet Count measurement

Datentyp

boolean

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

Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Life threatening illness Absent | Life threatening illness Excludes Chemotherapy

Datentyp

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.
Beschreibung

Serum conjugated bilirubin measurement

Datentyp

boolean

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

Alkaline phosphatase measurement | Transaminase Assay

Datentyp

boolean

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

Creatinine clearance measurement

Datentyp

boolean

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

HIV negative

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Hepatitis C virus Negative | Exception Absence Signs Chronic Hepatitis

Datentyp

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.
Beschreibung

Life Expectancy

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

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

Mental disorders Absent

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

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

Datentyp

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
Beschreibung

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

Datentyp

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)
Beschreibung

Diabetic - poor control | Antidiabetics Dose Stable

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Hypotension

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Malignant Neoplasms Evolving | Exception Skin carcinoma Localized

Datentyp

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
Beschreibung

HIV Seropositivity

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Hepatitis C Virus Positive | Exception Absence Signs Chronic Hepatitis

Datentyp

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
Beschreibung

Opportunistic Infections

Datentyp

boolean

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

Therapeutic radiology procedure Extensive | Systemic Chemotherapy | Cancer treatment

Datentyp

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
Beschreibung

Exposure to Rituximab

Datentyp

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.
Beschreibung

Investigational New Drugs | Investigational Medical Device

Datentyp

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
Beschreibung

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

Datentyp

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 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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