ID

36264

Beschreibung

A Clinical Research of CAR T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02349698

Link

https://clinicaltrials.gov/show/NCT02349698

Stichworte

Versionen (1)
  1. 25.04.19 25.04.19 -
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See clinicaltrials.gov

Hochgeladen am

25. April 2019

DOI

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Eligibility Leukemia NCT02349698

Englisch

Eligibility Leukemia NCT02349698

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02349698
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. relapsed or refractory b cell derived acute lymphoblastic leukemia(all), chronic lymphoblastic leukemia(cll) and non-hodgkin lymphoma.
Beschreibung

Adult B Acute Lymphoblastic Leukemia Recurrent | Adult B Acute Lymphoblastic Leukemia Refractory | Chronic Lymphocytic Leukemia | Lymphoma, Non-Hodgkin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279593
UMLS CUI [1,2]
C2945760
UMLS CUI [2,1]
C0279593
UMLS CUI [2,2]
C0205269
UMLS CUI [3]
C0023434
UMLS CUI [4]
C0024305
2. kps>60.
Beschreibung

Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
3. life expectancy>3 months.
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
4. gender unlimited, age from 18 years to 70 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
5. disease progresses but reserves reaction to recent treatments.
Beschreibung

Disease Progression

Datentyp

boolean

Alias
UMLS CUI [1]
C0242656
6. patients who have failed at least one line of a standard treatment.
Beschreibung

Standard therapy Quantity failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0231175
7. no serious mental disorder.
Beschreibung

Absence Mental disorders Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0004936
UMLS CUI [1,3]
C0205404
8. patients must have adequate cardiac function(no cardiac disease, lvef≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(cr≤133umol/l).
Beschreibung

Cardiac function | Heart Disease Absent | Left ventricular ejection fraction | Pulmonary function | Oxygen saturation measurement on room air | Renal function | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0428772
UMLS CUI [4]
C0231921
UMLS CUI [5,1]
C0523807
UMLS CUI [5,2]
C2709070
UMLS CUI [6]
C0232804
UMLS CUI [7]
C0201976
9. no other serious diseases(autoimmune disease, immunodeficiency etc.).
Beschreibung

Absence Disease Serious | Autoimmune Disease Absent | Immunodeficiency Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0205404
UMLS CUI [2,1]
C0004364
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0021051
UMLS CUI [3,2]
C0332197
10. no other tumors.
Beschreibung

Cancer Other Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0332197
11. patients volunteer to participate in the research.
Beschreibung

Participates as a volunteer Research

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1821911
UMLS CUI [1,2]
C0035168
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. kps<50.
Beschreibung

Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
2. patients are allergic to cytokines.
Beschreibung

Hypersensitivity Cytokine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0079189
3. central nervous system leukemia within 28 days.
Beschreibung

Central nervous system leukaemia

Datentyp

boolean

Alias
UMLS CUI [1]
C1332884
4. uncontrolled active infection.
Beschreibung

Communicable Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
5. acute or chronic gvhd.
Beschreibung

Graft-vs-Host Disease | Chronic graft-versus-host disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0018133
UMLS CUI [2]
C0867389
6. treated with t cell inhibitor.
Beschreibung

T cell Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0039194
UMLS CUI [1,2]
C0243077
7. pregnancy and nursing females.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. hiv affected.
Beschreibung

HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
9. other situations we think improper for the research.
Beschreibung

Social situation Inappropriate Research

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0748872
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0035168
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Ähnliche Modelle

Eligibility Leukemia NCT02349698

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02349698
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult B Acute Lymphoblastic Leukemia Recurrent | Adult B Acute Lymphoblastic Leukemia Refractory | Chronic Lymphocytic Leukemia | Lymphoma, Non-Hodgkin
Item
1. relapsed or refractory b cell derived acute lymphoblastic leukemia(all), chronic lymphoblastic leukemia(cll) and non-hodgkin lymphoma.
boolean
C0279593 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
C0279593 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0023434 (UMLS CUI [3])
C0024305 (UMLS CUI [4])
Karnofsky Performance Status
Item
2. kps>60.
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
3. life expectancy>3 months.
boolean
C0023671 (UMLS CUI [1])
Age
Item
4. gender unlimited, age from 18 years to 70 years.
boolean
C0001779 (UMLS CUI [1])
Disease Progression
Item
5. disease progresses but reserves reaction to recent treatments.
boolean
C0242656 (UMLS CUI [1])
Standard therapy Quantity failed
Item
6. patients who have failed at least one line of a standard treatment.
boolean
C2936643 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Absence Mental disorders Serious
Item
7. no serious mental disorder.
boolean
C0332197 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
Cardiac function | Heart Disease Absent | Left ventricular ejection fraction | Pulmonary function | Oxygen saturation measurement on room air | Renal function | Creatinine measurement, serum
Item
8. patients must have adequate cardiac function(no cardiac disease, lvef≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(cr≤133umol/l).
boolean
C0232164 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3])
C0231921 (UMLS CUI [4])
C0523807 (UMLS CUI [5,1])
C2709070 (UMLS CUI [5,2])
C0232804 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
Absence Disease Serious | Autoimmune Disease Absent | Immunodeficiency Absent
Item
9. no other serious diseases(autoimmune disease, immunodeficiency etc.).
boolean
C0332197 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0004364 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0021051 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Cancer Other Absent
Item
10. no other tumors.
boolean
C1707251 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Participates as a volunteer Research
Item
11. patients volunteer to participate in the research.
boolean
C1821911 (UMLS CUI [1,1])
C0035168 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Karnofsky Performance Status
Item
1. kps<50.
boolean
C0206065 (UMLS CUI [1])
Hypersensitivity Cytokine
Item
2. patients are allergic to cytokines.
boolean
C0020517 (UMLS CUI [1,1])
C0079189 (UMLS CUI [1,2])
Central nervous system leukaemia
Item
3. central nervous system leukemia within 28 days.
boolean
C1332884 (UMLS CUI [1])
Communicable Disease Uncontrolled
Item
4. uncontrolled active infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Graft-vs-Host Disease | Chronic graft-versus-host disease
Item
5. acute or chronic gvhd.
boolean
C0018133 (UMLS CUI [1])
C0867389 (UMLS CUI [2])
T cell Inhibitors
Item
6. treated with t cell inhibitor.
boolean
C0039194 (UMLS CUI [1,1])
C0243077 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
7. pregnancy and nursing females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Infection
Item
8. hiv affected.
boolean
C0019693 (UMLS CUI [1])
Social situation Inappropriate Research
Item
9. other situations we think improper for the research.
boolean
C0748872 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0035168 (UMLS CUI [1,3])
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