ID

15934

Description

Study of Blinatumomab in Japanese Adults With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02412306

Link

https://clinicaltrials.gov/show/NCT02412306

Keywords

Versions (1)
  1. 6/19/16 6/19/16 -
Uploaded on

June 19, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) NCT02412306

English

Eligibility Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) NCT02412306

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult subjects with philadelphia-negative b-precursor all, with any of the following:
Description

Adult | Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C4075283
relapsed or refractory after first line therapy with first remission duration
Description

Relapsed | Refractory | First line treatment | Disease remission First | Duration

Data type

boolean

Alias
UMLS CUI [1]
C0205336
UMLS CUI [2]
C0205269
UMLS CUI [3]
C1708063
UMLS CUI [4,1]
C0544452
UMLS CUI [4,2]
C0205435
UMLS CUI [5]
C0449238
≤ 12 months; or
Description

month

Data type

boolean

Alias
UMLS CUI [1]
C0439231
relapsed or refractory after first salvage therapy; or
Description

Relapsed | Refractory | Salvage Therapy First

Data type

boolean

Alias
UMLS CUI [1]
C0205336
UMLS CUI [2]
C0205269
UMLS CUI [3,1]
C0085405
UMLS CUI [3,2]
C0205435
relapsed or refractory within 12 months of allohsct
Description

Relapsed | Refractory | Allogeneic Hematopoietic Stem Cell Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0205336
UMLS CUI [2]
C0205269
UMLS CUI [3]
C1705576
5% or more blasts in bone marrow
Description

Bone marrow Blasts

Data type

boolean

Alias
UMLS CUI [1]
C1982687
in case of clinical signs of extramedullary disease in addition to medullary disease, disease must be measurable (at least one lesion ≥ 1.5 cm)
Description

Disease Extramedullary | Sign or Symptom | Disease Medulla Oblongata | Measurable Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1517060
UMLS CUI [2]
C3540840
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0025148
UMLS CUI [4]
C1513041
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with burkitt's leukemia according to world health organization (who) classification
Description

Burkitt Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0006413
history or presence of clinically relevant cental nervous system (cns) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, parkinson's disease, cerebellar disease, organic brain syndrome, psychosis; with the exception of well controlled cns leukemia
Description

CNS disorder | Epilepsy | Seizures | Paresis | Aphasia | Cerebrovascular accident | Brain Injuries Severe | Dementia | Parkinson Disease | Cerebellar Diseases | Organic brain syndrome | Psychotic Disorders | Central nervous system leukaemia Well controlled

Data type

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2]
C0014544
UMLS CUI [3]
C0036572
UMLS CUI [4]
C0030552
UMLS CUI [5]
C0003537
UMLS CUI [6]
C0038454
UMLS CUI [7,1]
C0270611
UMLS CUI [7,2]
C0205082
UMLS CUI [8]
C0497327
UMLS CUI [9]
C0030567
UMLS CUI [10]
C0007760
UMLS CUI [11]
C0029221
UMLS CUI [12]
C0033975
UMLS CUI [13,1]
C1332884
UMLS CUI [13,2]
C3853142
active all in the cns or testes
Description

Disorder of central nervous system co-occurrent and due to acute lymphoid leukemia | Acute lymphocytic leukemia Testes

Data type

boolean

Alias
UMLS CUI [1]
C4076109
UMLS CUI [2,1]
C0023449
UMLS CUI [2,2]
C0039597
current autoimmune disease or history of autoimmune disease with potential cns involvement
Description

Autoimmune Diseases Involvement with Central Nervous System

Data type

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C3714787
autologous hsct within 6 weeks prior to start of blinatumomab treatment
Description

autologous hematopoietic stem cell transplant | Therapeutic procedure blinatumomab

Data type

boolean

Alias
UMLS CUI [1]
C2193200
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C3853839
allohsct within 12 weeks prior to start of blinatumomab treatment
Description

Allogeneic Hematopoietic Stem Cell Transplantation | Therapeutic procedure blinatumomab

Data type

boolean

Alias
UMLS CUI [1]
C1705576
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C3853839
any active acute graft-versus-host disease (gvhd) grade 2-4 according to glucksberg criteria or active chronic gchd requiring systemic treatment
Description

Acute GVH disease | Glucksberg Scale | Graft-vs-Host Disease chronic | Requirement systemic therapy

Data type

boolean

Alias
UMLS CUI [1]
C0856825
UMLS CUI [2]
C1512203
UMLS CUI [3,1]
C0018133
UMLS CUI [3,2]
C0205191
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C1515119
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Similar models

Eligibility Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) NCT02412306

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia
Item
adult subjects with philadelphia-negative b-precursor all, with any of the following:
boolean
C0001675 (UMLS CUI [1])
C4075283 (UMLS CUI [2])
Relapsed | Refractory | First line treatment | Disease remission First | Duration
Item
relapsed or refractory after first line therapy with first remission duration
boolean
C0205336 (UMLS CUI [1])
C0205269 (UMLS CUI [2])
C1708063 (UMLS CUI [3])
C0544452 (UMLS CUI [4,1])
C0205435 (UMLS CUI [4,2])
C0449238 (UMLS CUI [5])
month
Item
≤ 12 months; or
boolean
C0439231 (UMLS CUI [1])
Relapsed | Refractory | Salvage Therapy First
Item
relapsed or refractory after first salvage therapy; or
boolean
C0205336 (UMLS CUI [1])
C0205269 (UMLS CUI [2])
C0085405 (UMLS CUI [3,1])
C0205435 (UMLS CUI [3,2])
Relapsed | Refractory | Allogeneic Hematopoietic Stem Cell Transplantation
Item
relapsed or refractory within 12 months of allohsct
boolean
C0205336 (UMLS CUI [1])
C0205269 (UMLS CUI [2])
C1705576 (UMLS CUI [3])
Bone marrow Blasts
Item
5% or more blasts in bone marrow
boolean
C1982687 (UMLS CUI [1])
Disease Extramedullary | Sign or Symptom | Disease Medulla Oblongata | Measurable Disease
Item
in case of clinical signs of extramedullary disease in addition to medullary disease, disease must be measurable (at least one lesion ≥ 1.5 cm)
boolean
C0012634 (UMLS CUI [1,1])
C1517060 (UMLS CUI [1,2])
C3540840 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0025148 (UMLS CUI [3,2])
C1513041 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Burkitt Leukemia
Item
subjects with burkitt's leukemia according to world health organization (who) classification
boolean
C0006413 (UMLS CUI [1])
CNS disorder | Epilepsy | Seizures | Paresis | Aphasia | Cerebrovascular accident | Brain Injuries Severe | Dementia | Parkinson Disease | Cerebellar Diseases | Organic brain syndrome | Psychotic Disorders | Central nervous system leukaemia Well controlled
Item
history or presence of clinically relevant cental nervous system (cns) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, parkinson's disease, cerebellar disease, organic brain syndrome, psychosis; with the exception of well controlled cns leukemia
boolean
C0007682 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
C0036572 (UMLS CUI [3])
C0030552 (UMLS CUI [4])
C0003537 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
C0270611 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0497327 (UMLS CUI [8])
C0030567 (UMLS CUI [9])
C0007760 (UMLS CUI [10])
C0029221 (UMLS CUI [11])
C0033975 (UMLS CUI [12])
C1332884 (UMLS CUI [13,1])
C3853142 (UMLS CUI [13,2])
Disorder of central nervous system co-occurrent and due to acute lymphoid leukemia | Acute lymphocytic leukemia Testes
Item
active all in the cns or testes
boolean
C4076109 (UMLS CUI [1])
C0023449 (UMLS CUI [2,1])
C0039597 (UMLS CUI [2,2])
Autoimmune Diseases Involvement with Central Nervous System
Item
current autoimmune disease or history of autoimmune disease with potential cns involvement
boolean
C0004364 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C3714787 (UMLS CUI [1,3])
autologous hematopoietic stem cell transplant | Therapeutic procedure blinatumomab
Item
autologous hsct within 6 weeks prior to start of blinatumomab treatment
boolean
C2193200 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C3853839 (UMLS CUI [2,2])
Allogeneic Hematopoietic Stem Cell Transplantation | Therapeutic procedure blinatumomab
Item
allohsct within 12 weeks prior to start of blinatumomab treatment
boolean
C1705576 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C3853839 (UMLS CUI [2,2])
Acute GVH disease | Glucksberg Scale | Graft-vs-Host Disease chronic | Requirement systemic therapy
Item
any active acute graft-versus-host disease (gvhd) grade 2-4 according to glucksberg criteria or active chronic gchd requiring systemic treatment
boolean
C0856825 (UMLS CUI [1])
C1512203 (UMLS CUI [2])
C0018133 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C1515119 (UMLS CUI [4,2])
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