ID

41095

Beschrijving

Phase I/II Study of Moxetumomab; ODM derived from: https://clinicaltrials.gov/show/NCT01891981

Link

https://clinicaltrials.gov/show/NCT01891981

Trefwoorden

Versies (1)
  1. 2020-06-23 2020-06-23 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

23 juni 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Leukemia NCT01891981

Engels

Eligibility Leukemia NCT01891981

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01891981
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients age 18 years or older with previously treated all (relapsed and/or refractory after prior therapy); patients with relapsed/refractory biphenotypic leukemia expressing the appropriate antigen (cd22) are also eligible to participate, pediatric patients younger than 18 may be considered with sponsor approval once the mtd has been established in the adult population.
Beschrijving

Age | Acute lymphocytic leukemia recurrent | Acute lymphocytic leukemia refractory | Status post Prior Therapy | Acute biphenotypic leukemia in relapse CD22 Positive | Acute biphenotypic leukemia refractory CD22 Positive

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1504403
UMLS CUI [3]
C4049242
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C1514463
UMLS CUI [5,1]
C4067209
UMLS CUI [5,2]
C4329508
UMLS CUI [6,1]
C0023464
UMLS CUI [6,2]
C0205269
UMLS CUI [6,3]
C4329508
2. ecog performance status 0-2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
3. adequate liver function (bilirubin less than or equal to 1.5 mg/dl and sgpt or sgot less than or equal 2.5 x upper limit of normal [uln], unless considered due to tumor or hemolysis), and renal function ( calculated crcl of greater than or equal to 50 or serum creatinine less than 2 x uln.) even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is less than or equal to 2.0 mg/dl (unless due to hemolysis or gilbert's disease, i.e. mainly indirect bilirubin) and creatinine less than or equal 2 mg/dl
Beschrijving

Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Exception Due to Neoplasm | Exception Due to Hemolysis | Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine measurement, serum | Serum total bilirubin measurement | Exception Due to Hemolysis | Exception Due to Gilbert Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0027651
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0678226
UMLS CUI [6,3]
C0019054
UMLS CUI [7]
C0232804
UMLS CUI [8]
C2711451
UMLS CUI [9]
C0201976
UMLS CUI [10]
C1278039
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0678226
UMLS CUI [11,3]
C0019054
UMLS CUI [12,1]
C1705847
UMLS CUI [12,2]
C0678226
UMLS CUI [12,3]
C0017551
4. provision of written informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient with active heart disease (nyha class greater than or equal to 2 as assessed by history and physical examination).
Beschrijving

Heart Disease New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
2. patients with a cardiac ejection fraction (as measured by either muga or echocardiogram) less than 40%
Beschrijving

Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0013516
3. patients with active hepatitis
Beschrijving

Hepatitis

Datatype

boolean

Alias
UMLS CUI [1]
C0019158
4. pregnant or breast-feeding women. women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of start of treatment.
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430057
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0430061
5. prior radioimmunotherapy within 3 years of enrollment
Beschrijving

Radioimmunotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0085101
6. serum albumin less than 2g/dl
Beschrijving

Serum albumin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0523465
7. oxygen saturation at rest by pulse oximetry less than 88% or pao2 less than or equal to 55mm hg
Beschrijving

Oxygen saturation by pulse oximetry, resting | PaO2 measurement

Datatype

boolean

Alias
UMLS CUI [1]
C4736814
UMLS CUI [2]
C1283004
8. history of microangiopathic hemolysis, ttp or hus.
Beschrijving

Other Coding | Microangiopathic hemolytic anemia | Purpura, Thrombotic Thrombocytopenic | Hemolytic-Uremic Syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2]
C0221021
UMLS CUI [3]
C0034155
UMLS CUI [4]
C0019061
9. symptomatic cns involvement
Beschrijving

Central Nervous System Involvement Symptomatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0231220
10. less than 100 days post -transplant or any evidence of active gvhd
Beschrijving

Status post Transplantation | Graft-vs-Host Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0040732
UMLS CUI [2]
C0018133
11. systemic chemotherapy less than 14 days prior; however treatment may start earlier if there is evidence of rapidly progressive disease if approved by the principal investigator
Beschrijving

Systemic Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C1883256
12. monoclonal antibody therapy less than 1 month
Beschrijving

Monoclonal Antibody Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0279694
13. investigational agents within 28 days of dosing; however treatment may start earlier if there is evidence of rapidly progressive disease if approved by the principal investigator
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
14. hiv+/aids
Beschrijving

HIV Seropositivity | AIDS

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0001175
15. history of exposure to pseudomonas exotoxin containing molecule
Beschrijving

Exposure to Pseudomonas exotoxin Containing Molecule

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0072544
UMLS CUI [1,3]
C0332256
UMLS CUI [1,4]
C0567416
16. patients with active lung infection or active pulmonary edema.
Beschrijving

Infectious Lung Disorder | Pulmonary Edema

Datatype

boolean

Alias
UMLS CUI [1]
C0876973
UMLS CUI [2]
C0034063
17. patients with laboratory findings consistent with grade equal to greater than 3 disseminated intravascular coagulation (dic) or any grade 2 dic that does not correct.
Beschrijving

Laboratory test finding Consistent with Disseminated Intravascular Coagulation Grade | Disseminated Intravascular Coagulation Grade

Datatype

boolean

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0012739
UMLS CUI [1,4]
C0441800
UMLS CUI [2,1]
C0012739
UMLS CUI [2,2]
C0441800
18. patients with clinically significant ophthalmologic findings (as determined by an ophthalmologist) during screening should be excluded from the trial
Beschrijving

Ophthalmological test finding Clinical Significance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0429488
UMLS CUI [1,2]
C2826293
19. pre-treatment greater than qtc interval of 490 ms
Beschrijving

Prolonged QTc interval

Datatype

boolean

Alias
UMLS CUI [1]
C1560305
Terug naar het begin van de pagina

Similar models

Eligibility Leukemia NCT01891981

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01891981
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Acute lymphocytic leukemia recurrent | Acute lymphocytic leukemia refractory | Status post Prior Therapy | Acute biphenotypic leukemia in relapse CD22 Positive | Acute biphenotypic leukemia refractory CD22 Positive
Item
1. patients age 18 years or older with previously treated all (relapsed and/or refractory after prior therapy); patients with relapsed/refractory biphenotypic leukemia expressing the appropriate antigen (cd22) are also eligible to participate, pediatric patients younger than 18 may be considered with sponsor approval once the mtd has been established in the adult population.
boolean
C0001779 (UMLS CUI [1])
C1504403 (UMLS CUI [2])
C4049242 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C1514463 (UMLS CUI [4,2])
C4067209 (UMLS CUI [5,1])
C4329508 (UMLS CUI [5,2])
C0023464 (UMLS CUI [6,1])
C0205269 (UMLS CUI [6,2])
C4329508 (UMLS CUI [6,3])
ECOG performance status
Item
2. ecog performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Exception Due to Neoplasm | Exception Due to Hemolysis | Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine measurement, serum | Serum total bilirubin measurement | Exception Due to Hemolysis | Exception Due to Gilbert Disease
Item
3. adequate liver function (bilirubin less than or equal to 1.5 mg/dl and sgpt or sgot less than or equal 2.5 x upper limit of normal [uln], unless considered due to tumor or hemolysis), and renal function ( calculated crcl of greater than or equal to 50 or serum creatinine less than 2 x uln.) even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is less than or equal to 2.0 mg/dl (unless due to hemolysis or gilbert's disease, i.e. mainly indirect bilirubin) and creatinine less than or equal 2 mg/dl
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0027651 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C0019054 (UMLS CUI [6,3])
C0232804 (UMLS CUI [7])
C2711451 (UMLS CUI [8])
C0201976 (UMLS CUI [9])
C1278039 (UMLS CUI [10])
C1705847 (UMLS CUI [11,1])
C0678226 (UMLS CUI [11,2])
C0019054 (UMLS CUI [11,3])
C1705847 (UMLS CUI [12,1])
C0678226 (UMLS CUI [12,2])
C0017551 (UMLS CUI [12,3])
Informed Consent
Item
4. provision of written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Heart Disease New York Heart Association Classification
Item
1. patient with active heart disease (nyha class greater than or equal to 2 as assessed by history and physical examination).
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography
Item
2. patients with a cardiac ejection fraction (as measured by either muga or echocardiogram) less than 40%
boolean
C0232174 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Hepatitis
Item
3. patients with active hepatitis
boolean
C0019158 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative
Item
4. pregnant or breast-feeding women. women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of start of treatment.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430057 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0430061 (UMLS CUI [4,2])
Radioimmunotherapy
Item
5. prior radioimmunotherapy within 3 years of enrollment
boolean
C0085101 (UMLS CUI [1])
Serum albumin measurement
Item
6. serum albumin less than 2g/dl
boolean
C0523465 (UMLS CUI [1])
Oxygen saturation by pulse oximetry, resting | PaO2 measurement
Item
7. oxygen saturation at rest by pulse oximetry less than 88% or pao2 less than or equal to 55mm hg
boolean
C4736814 (UMLS CUI [1])
C1283004 (UMLS CUI [2])
Other Coding | Microangiopathic hemolytic anemia | Purpura, Thrombotic Thrombocytopenic | Hemolytic-Uremic Syndrome
Item
8. history of microangiopathic hemolysis, ttp or hus.
boolean
C3846158 (UMLS CUI [1])
C0221021 (UMLS CUI [2])
C0034155 (UMLS CUI [3])
C0019061 (UMLS CUI [4])
Central Nervous System Involvement Symptomatic
Item
9. symptomatic cns involvement
boolean
C4050309 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Status post Transplantation | Graft-vs-Host Disease
Item
10. less than 100 days post -transplant or any evidence of active gvhd
boolean
C0231290 (UMLS CUI [1,1])
C0040732 (UMLS CUI [1,2])
C0018133 (UMLS CUI [2])
Systemic Chemotherapy
Item
11. systemic chemotherapy less than 14 days prior; however treatment may start earlier if there is evidence of rapidly progressive disease if approved by the principal investigator
boolean
C1883256 (UMLS CUI [1])
Monoclonal Antibody Therapy
Item
12. monoclonal antibody therapy less than 1 month
boolean
C0279694 (UMLS CUI [1])
Investigational New Drugs
Item
13. investigational agents within 28 days of dosing; however treatment may start earlier if there is evidence of rapidly progressive disease if approved by the principal investigator
boolean
C0013230 (UMLS CUI [1])
HIV Seropositivity | AIDS
Item
14. hiv+/aids
boolean
C0019699 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
Exposure to Pseudomonas exotoxin Containing Molecule
Item
15. history of exposure to pseudomonas exotoxin containing molecule
boolean
C0332157 (UMLS CUI [1,1])
C0072544 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
C0567416 (UMLS CUI [1,4])
Infectious Lung Disorder | Pulmonary Edema
Item
16. patients with active lung infection or active pulmonary edema.
boolean
C0876973 (UMLS CUI [1])
C0034063 (UMLS CUI [2])
Laboratory test finding Consistent with Disseminated Intravascular Coagulation Grade | Disseminated Intravascular Coagulation Grade
Item
17. patients with laboratory findings consistent with grade equal to greater than 3 disseminated intravascular coagulation (dic) or any grade 2 dic that does not correct.
boolean
C0587081 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0012739 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
C0012739 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
Ophthalmological test finding Clinical Significance
Item
18. patients with clinically significant ophthalmologic findings (as determined by an ophthalmologist) during screening should be excluded from the trial
boolean
C0429488 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Prolonged QTc interval
Item
19. pre-treatment greater than qtc interval of 490 ms
boolean
C1560305 (UMLS CUI [1])
Terug naar het begin van de pagina 

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