Eligibility Non-Hodgkin Lymphoma NCT01032681

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StudyEvent: Eligibility
1. Eligibility Non-Hodgkin Lymphoma NCT01032681

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

informed consent

Item

1. signed written informed consent

boolean

C0021430 (UMLS CUI [1])

gender, age, treatment cycle

Item

2. male or female, aged ≥ 18 years, inpatient for treatment phase of cycle 1 and 2, outpatient treatment possible for subsequent cycles

boolean

C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1302181 (UMLS CUI [3])

metastatic or locally advanced tumor, b-cell non-hogdkin lymphoma

Item

3. histologically or cytologically proven metastatic or locally advanced solid tumors (epithelial or mesenchymal cancers) or b-cell non-hodgkin lymphoma for which no standard therapy exists or after failure of standard therapy

boolean

C2939420 (UMLS CUI [1])
C0677984 (UMLS CUI [2])
C0079731 (UMLS CUI [3,1])
C0024305 (UMLS CUI [3,2])

ecog, life expectancy

Item

4. eastern cooperative oncology group (ecog) performance status of 0 to 1 at study entry and an estimated life expectancy of at least 3 months

boolean

C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])

hematologic function, wbc, anc, lymphocyte count, platelet count, hemoglobin

Item

5. adequate hematological function defined by wbc count ≥ 3 x 109/l with absolute neutrophil count (anc) ≥ 1.5 x 109/l and lymphocyte count ≥ 0.5 x 109/l; platelet count ≥100 x 109/l; hemoglobin ≥9 g/dl ( if the laboratory values for hemoglobin are outside the required entry level at screening, a patient may receive a transfusion of rbc. a stable hemoglobin level of ≥9 mg/dl for at least 7 days must be achieved prior to receiving the first dose of study medication.)

boolean

C0221130 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C0948762C0200635 (UMLS CUI [1,3])
C0005821 (UMLS CUI [1,4])
C0019046 (UMLS CUI [1,5])

hepatic function

Item

6. adequate hepatic function defined by a total bilirubin level ≤ 1.5 times the upper limit of normal (uln) and aspartate-aminotransferase (ast) and alanine-aminotransferase (alt) levels ≤ 2.5 x uln or, for patients with documented metastatic disease to the liver, ast and alt levels ≤ 5 x uln

boolean

C0232741 (UMLS CUI [1,1])
C1278039 (UMLS CUI [1,2])
C0201836 (UMLS CUI [1,3])
C0201899 (UMLS CUI [1,4])

kidney function

Item

7. no history of acute or chronic kidney disease and adequate renal function defined by an estimated creatinine clearance above 50 ml/min determined by 24-hour urine sampling or by the cockcroft-gault formula

boolean

C0232804 (UMLS CUI [1,1])
C0812399 (UMLS CUI [1,2])

effective contraception

Item

8. effective contraception for both male and female subjects if the risk of conception exists

boolean

C0700589 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

il-2 therapy

Item

1. prior il-2 therapy within the last 6 months

boolean

C0199975 (UMLS CUI [1])

cancer treatment, immunosuppression

Item

2. requirement for concurrent anticancer treatment (chemotherapy, radiotherapy, immune therapy, cytokine therapy except erythropoietin) or for concurrent systemic therapy with steroids or other immunosuppressive agents. short-term administration of steroids (i.e. for allergic reactions) is allowed.

boolean

C0920425 (UMLS CUI [1])
C0021079 (UMLS CUI [2])

radiotherapy, chemotherapy, surgery, investigational drug

Item

3. radiotherapy, chemotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before the start of treatment in this study

boolean

C1522449 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C0013230 (UMLS CUI [4])

immunodeficiency

Item

4. acquired immune defects such as human immunodeficiency virus (hiv)

boolean

C0021051 (UMLS CUI [1])

autoimmune disease

Item

5. systemic autoimmune disease (e.g. lupus erythematodes, rheumatoid arthritis, addison's disease, autoimmune disease associated with lymphoma)

boolean

C0004364 (UMLS CUI [1])

organ transplant recipient

Item

6. organ transplant recipients

boolean

C0376387 (UMLS CUI [1])

inflammatory bowel disease

Item

7. history of or active inflammatory bowel disease (e.g. crohn's disease, ulcerative colitis)

boolean

C0021390 (UMLS CUI [1])

chronic viral infections

Item

8. chronic viral infections (e.g. hepatitis b virus [hbv], hepatitis c virus [hcv])

boolean

C0042769 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])

uncontrolled hypertension

Item

9. uncontrolled hypertension (systolic >180 mmhg, diastolic >100 mmhg)

boolean

C1868885 (UMLS CUI [1])

drug hypersensitivity

Item

10. known hypersensitivity reactions to any of the compounds of the study medication

boolean

C0013182 (UMLS CUI [1])

brain metastases

Item

11. confirmed or clinically suspected brain metastases

boolean

C0220650 (UMLS CUI [1])

pregnancy, breast feeding

Item

12. pregnancy (absence to be confirmed by beta-human chorionic gonadotropin [β-hcg] test) or lactation period

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

cardiovascular disease

Item

13. clinically significant (i.e. active) cardiovascular disease: cerebral vascular accident /stroke (< 6 months prior to enrolment), myocardial infarction (< 6 months prior to enrolment), unstable angina, congestive heart failure or serious cardiac arrhythmia requiring medication.

boolean

C0007222 (UMLS CUI [1])

pulmonary disease

Item

14. pulmonary disease which, in the opinion of the investigator, might impair the patient's respiratory tolerance to moderate pulmonary fluid overload (e.g. interstitial lung disease, severe chronic obstructive pulmonary disease)

boolean

C0024115 (UMLS CUI [1])

necroses

Item

15. all conditions which are associated with significant necroses of non tumor-bearing tissues like e.g. esophageal or gastroduodenal ulcers (< 6 months prior to enrolment), organ infarctions (< 6 months prior to enrolment) or active ischemic bowel disease

boolean

C0027540 (UMLS CUI [1])

third space fluid

Item

16. presence of medically significant third space fluid (pericardial effusion or ascites/ pleural infusion requiring repetitive paracentesis)

boolean

C0031039 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0032227 (UMLS CUI [3])

alcohol or drug abuse

Item

17. known alcohol or drug abuse

boolean

C0038586 (UMLS CUI [1])

study participation

Item

18. participation in another clinical trial within the past 30 days before start of study treatment

boolean

C2348568 (UMLS CUI [1])

comorbidities

Item

19. all other significant diseases which, in the opinion of the investigator, might impair the patient's tolerance of study treatment.

boolean

C0009488 (UMLS CUI [1])

mental disorder

Item

20. dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent

boolean

C0004936 (UMLS CUI [1])

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Eligibility Non-Hodgkin Lymphoma NCT01032681