ID

37004

Beskrivning

HM2014-26 DT2219 for Relapsed or Refractory B-Lineage Leukemia or Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02370160

Länk

https://clinicaltrials.gov/show/NCT02370160

Nyckelord

Versioner (1)
  1. 2019-06-29 2019-06-29 -
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See clinicaltrials.gov

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29 juni 2019

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Eligibility Refractory B-Lineage Leukemia NCT02370160

Engelsk

Eligibility Refractory B-Lineage Leukemia NCT02370160

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic verification of b-cell lineage leukemia or b cell non-hodgkin lymphoma and evidence of relapse/refractory disease with the presence of cd19 and/or cd22 by flow cytometry or immunohistochemistry of bone marrow aspirate, peripheral blood or node/tumor biopsy
Beskrivning

Leukemia, B-Cell | B-Cell Lymphoma | Relapse | Refractory Disease | CD19 Positive Flow Cytometry Bone Marrow aspirate | CD22 Positive Flow Cytometry Bone Marrow aspirate | CD19 Positive Immunohistochemistry Bone Marrow aspirate | CD22 Positive Immunohistochemistry Bone Marrow aspirate | CD19 Positive Peripheral blood Biopsy | CD22 Positive Peripheral blood Biopsy | CD19 Positive Biopsy of lymph node | CD22 Positive Biopsy of lymph node | CD19 Positive Tumor Biopsy | CD22 Positive Tumor Biopsy

Datatyp

boolean

Alias
UMLS CUI [1]
C2004493
UMLS CUI [2]
C0079731
UMLS CUI [3]
C0035020
UMLS CUI [4]
C1514815
UMLS CUI [5,1]
C4289895
UMLS CUI [5,2]
C0016263
UMLS CUI [5,3]
C0857285
UMLS CUI [6,1]
C4329508
UMLS CUI [6,2]
C0016263
UMLS CUI [6,3]
C0857285
UMLS CUI [7,1]
C4289895
UMLS CUI [7,2]
C0021044
UMLS CUI [7,3]
C0857285
UMLS CUI [8,1]
C4329508
UMLS CUI [8,2]
C0021044
UMLS CUI [8,3]
C0857285
UMLS CUI [9,1]
C4289895
UMLS CUI [9,2]
C0229664
UMLS CUI [9,3]
C0005558
UMLS CUI [10,1]
C4329508
UMLS CUI [10,2]
C0229664
UMLS CUI [10,3]
C0005558
UMLS CUI [11,1]
C4289895
UMLS CUI [11,2]
C0193842
UMLS CUI [12,1]
C4329508
UMLS CUI [12,2]
C0193842
UMLS CUI [13,1]
C4289895
UMLS CUI [13,2]
C0027651
UMLS CUI [13,3]
C0005558
UMLS CUI [14,1]
C4329508
UMLS CUI [14,2]
C0027651
UMLS CUI [14,3]
C0005558
disease refractory to conventional therapy and other therapies of higher priority
Beskrivning

Refractory Disease Conventional Treatment | Refractory Disease Therapy High priority

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514815
UMLS CUI [1,2]
C2945704
UMLS CUI [2,1]
C1514815
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C1273516
karnofsky performance status of ≥ 60% or, if less than 16 years of age, lansky play score of ≥ 60 (appendix ii)
Beskrivning

Karnofsky Performance Status | Lansky Play-Performance Status Age Related

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2,1]
C1522275
UMLS CUI [2,2]
C0001779
UMLS CUI [2,3]
C0439849
recovered from effects of prior therapy
Beskrivning

Effects of Prior Therapy | Patient recovered

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1704420
UMLS CUI [1,2]
C1514463
UMLS CUI [2]
C1115804
peripheral blast count under 50 x 109/l
Beskrivning

Peripheral blast Count

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4087328
UMLS CUI [1,2]
C0750480
adequate organ function within 14 days (30 days for cardiac and pulmonary) of treatment start
Beskrivning

Organ function | Cardiac function | Pulmonary function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0232164
UMLS CUI [3]
C0231921
agrees to stay within the twin cities metropolitan area (i.e. within 30 miles of the study center) during the treatment period and has a capable caregiver (outpatient only)
Beskrivning

Relocation of home Absent | Outpatient Availability of Caregiver

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0029921
UMLS CUI [2,2]
C0470187
UMLS CUI [2,3]
C0085537
women of childbearing potential and men should be advised and agree to practice effective methods of contraception during the course of study
Beskrivning

Childbearing Potential Contraceptive methods | Gender Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of leukemic or infectious pulmonary parenchymal disease
Beskrivning

Lung disease Parenchymal Leukemic | Lung disease Parenchymal Infectious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C4277702
UMLS CUI [1,3]
C0162679
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C4277702
UMLS CUI [2,3]
C0009450
presence of active cns leukemia - csf with <5 wbc/ul will not exclude the patient
Beskrivning

Central nervous system leukaemia

Datatyp

boolean

Alias
UMLS CUI [1]
C1332884
presence of any uncontrolled systemic infection
Beskrivning

Sepsis Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C0205318
documented uncontrolled seizure disorder- a seizure disorder controlled with medication
Beskrivning

Epilepsy Uncontrolled | Epilepsy controlled with medications

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0014544
UMLS CUI [2,2]
C0742801
active neurologic disorder - peripheral neuropathy alone does not exclude a patient
Beskrivning

Nervous system disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0027765
documented penicillin or cephalosporin allergies
Beskrivning

Allergy to penicillin | Cephalosporin allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C0030824
UMLS CUI [2]
C0571444
pregnant or lactating
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Refractory B-Lineage Leukemia NCT02370160

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Leukemia, B-Cell | B-Cell Lymphoma | Relapse | Refractory Disease | CD19 Positive Flow Cytometry Bone Marrow aspirate | CD22 Positive Flow Cytometry Bone Marrow aspirate | CD19 Positive Immunohistochemistry Bone Marrow aspirate | CD22 Positive Immunohistochemistry Bone Marrow aspirate | CD19 Positive Peripheral blood Biopsy | CD22 Positive Peripheral blood Biopsy | CD19 Positive Biopsy of lymph node | CD22 Positive Biopsy of lymph node | CD19 Positive Tumor Biopsy | CD22 Positive Tumor Biopsy
Item
histologic verification of b-cell lineage leukemia or b cell non-hodgkin lymphoma and evidence of relapse/refractory disease with the presence of cd19 and/or cd22 by flow cytometry or immunohistochemistry of bone marrow aspirate, peripheral blood or node/tumor biopsy
boolean
C2004493 (UMLS CUI [1])
C0079731 (UMLS CUI [2])
C0035020 (UMLS CUI [3])
C1514815 (UMLS CUI [4])
C4289895 (UMLS CUI [5,1])
C0016263 (UMLS CUI [5,2])
C0857285 (UMLS CUI [5,3])
C4329508 (UMLS CUI [6,1])
C0016263 (UMLS CUI [6,2])
C0857285 (UMLS CUI [6,3])
C4289895 (UMLS CUI [7,1])
C0021044 (UMLS CUI [7,2])
C0857285 (UMLS CUI [7,3])
C4329508 (UMLS CUI [8,1])
C0021044 (UMLS CUI [8,2])
C0857285 (UMLS CUI [8,3])
C4289895 (UMLS CUI [9,1])
C0229664 (UMLS CUI [9,2])
C0005558 (UMLS CUI [9,3])
C4329508 (UMLS CUI [10,1])
C0229664 (UMLS CUI [10,2])
C0005558 (UMLS CUI [10,3])
C4289895 (UMLS CUI [11,1])
C0193842 (UMLS CUI [11,2])
C4329508 (UMLS CUI [12,1])
C0193842 (UMLS CUI [12,2])
C4289895 (UMLS CUI [13,1])
C0027651 (UMLS CUI [13,2])
C0005558 (UMLS CUI [13,3])
C4329508 (UMLS CUI [14,1])
C0027651 (UMLS CUI [14,2])
C0005558 (UMLS CUI [14,3])
Refractory Disease Conventional Treatment | Refractory Disease Therapy High priority
Item
disease refractory to conventional therapy and other therapies of higher priority
boolean
C1514815 (UMLS CUI [1,1])
C2945704 (UMLS CUI [1,2])
C1514815 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1273516 (UMLS CUI [2,3])
Karnofsky Performance Status | Lansky Play-Performance Status Age Related
Item
karnofsky performance status of ≥ 60% or, if less than 16 years of age, lansky play score of ≥ 60 (appendix ii)
boolean
C0206065 (UMLS CUI [1])
C1522275 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
Effects of Prior Therapy | Patient recovered
Item
recovered from effects of prior therapy
boolean
C1704420 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C1115804 (UMLS CUI [2])
Peripheral blast Count
Item
peripheral blast count under 50 x 109/l
boolean
C4087328 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Organ function | Cardiac function | Pulmonary function
Item
adequate organ function within 14 days (30 days for cardiac and pulmonary) of treatment start
boolean
C0678852 (UMLS CUI [1])
C0232164 (UMLS CUI [2])
C0231921 (UMLS CUI [3])
Relocation of home Absent | Outpatient Availability of Caregiver
Item
agrees to stay within the twin cities metropolitan area (i.e. within 30 miles of the study center) during the treatment period and has a capable caregiver (outpatient only)
boolean
C2699029 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0029921 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C0085537 (UMLS CUI [2,3])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
women of childbearing potential and men should be advised and agree to practice effective methods of contraception during the course of study
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Lung disease Parenchymal Leukemic | Lung disease Parenchymal Infectious
Item
presence of leukemic or infectious pulmonary parenchymal disease
boolean
C0024115 (UMLS CUI [1,1])
C4277702 (UMLS CUI [1,2])
C0162679 (UMLS CUI [1,3])
C0024115 (UMLS CUI [2,1])
C4277702 (UMLS CUI [2,2])
C0009450 (UMLS CUI [2,3])
Central nervous system leukaemia
Item
presence of active cns leukemia - csf with <5 wbc/ul will not exclude the patient
boolean
C1332884 (UMLS CUI [1])
Sepsis Uncontrolled
Item
presence of any uncontrolled systemic infection
boolean
C0243026 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Epilepsy Uncontrolled | Epilepsy controlled with medications
Item
documented uncontrolled seizure disorder- a seizure disorder controlled with medication
boolean
C0014544 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0014544 (UMLS CUI [2,1])
C0742801 (UMLS CUI [2,2])
Nervous system disorder
Item
active neurologic disorder - peripheral neuropathy alone does not exclude a patient
boolean
C0027765 (UMLS CUI [1])
Allergy to penicillin | Cephalosporin allergy
Item
documented penicillin or cephalosporin allergies
boolean
C0030824 (UMLS CUI [1])
C0571444 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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