ID

22146

Beskrivning

EMD 521873 in Advanced Solid Tumors, MTD Finding; ODM derived from: https://clinicaltrials.gov/show/NCT01032681

Länk

https://clinicaltrials.gov/show/NCT01032681

Nyckelord

Versioner (1)
  1. 2017-05-21 2017-05-21 -
Uppladdad den

21 maj 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-Hodgkin Lymphoma NCT01032681

Engelsk

Eligibility Non-Hodgkin Lymphoma NCT01032681

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. signed written informed consent
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
2. male or female, aged ≥ 18 years, inpatient for treatment phase of cycle 1 and 2, outpatient treatment possible for subsequent cycles
Beskrivning

gender, age, treatment cycle

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C1302181
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
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C2939420
UMLS CUI [2]
C0677984
UMLS CUI [3,1]
C0079731
UMLS CUI [3,2]
C0024305
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
Beskrivning

ecog, life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0023671
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.)
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0023508
UMLS CUI [1,3]
C0948762C0200635
UMLS CUI [1,4]
C0005821
UMLS CUI [1,5]
C0019046
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
Beskrivning

hepatic function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C1278039
UMLS CUI [1,3]
C0201836
UMLS CUI [1,4]
C0201899
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
Beskrivning

kidney function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0812399
8. effective contraception for both male and female subjects if the risk of conception exists
Beskrivning

effective contraception

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior il-2 therapy within the last 6 months
Beskrivning

il-2 therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0199975
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.
Beskrivning

cancer treatment, immunosuppression

Datatyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0021079
3. radiotherapy, chemotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before the start of treatment in this study
Beskrivning

radiotherapy, chemotherapy, surgery, investigational drug

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0543467
UMLS CUI [4]
C0013230
4. acquired immune defects such as human immunodeficiency virus (hiv)
Beskrivning

immunodeficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C0021051
5. systemic autoimmune disease (e.g. lupus erythematodes, rheumatoid arthritis, addison's disease, autoimmune disease associated with lymphoma)
Beskrivning

autoimmune disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0004364
6. organ transplant recipients
Beskrivning

organ transplant recipient

Datatyp

boolean

Alias
UMLS CUI [1]
C0376387
7. history of or active inflammatory bowel disease (e.g. crohn's disease, ulcerative colitis)
Beskrivning

inflammatory bowel disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0021390
8. chronic viral infections (e.g. hepatitis b virus [hbv], hepatitis c virus [hcv])
Beskrivning

chronic viral infections

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042769
UMLS CUI [1,2]
C0205191
9. uncontrolled hypertension (systolic >180 mmhg, diastolic >100 mmhg)
Beskrivning

uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
10. known hypersensitivity reactions to any of the compounds of the study medication
Beskrivning

drug hypersensitivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0013182
11. confirmed or clinically suspected brain metastases
Beskrivning

brain metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
12. pregnancy (absence to be confirmed by beta-human chorionic gonadotropin [β-hcg] test) or lactation period
Beskrivning

pregnancy, breast feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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.
Beskrivning

cardiovascular disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
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)
Beskrivning

pulmonary disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0024115
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
Beskrivning

necroses

Datatyp

boolean

Alias
UMLS CUI [1]
C0027540
16. presence of medically significant third space fluid (pericardial effusion or ascites/ pleural infusion requiring repetitive paracentesis)
Beskrivning

third space fluid

Datatyp

boolean

Alias
UMLS CUI [1]
C0031039
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0032227
17. known alcohol or drug abuse
Beskrivning

alcohol or drug abuse

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
18. participation in another clinical trial within the past 30 days before start of study treatment
Beskrivning

study participation

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
19. all other significant diseases which, in the opinion of the investigator, might impair the patient's tolerance of study treatment.
Beskrivning

comorbidities

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
20. dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
Beskrivning

mental disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0004936
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Similar models

Eligibility Non-Hodgkin Lymphoma NCT01032681

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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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