ID

41129

Description

A Study of CSL362 in Patients With CD123+ Acute Myeloid Leukemia Currently in Remission; ODM derived from: https://clinicaltrials.gov/show/NCT01632852

Link

https://clinicaltrials.gov/show/NCT01632852

Keywords

Versions (1)
  1. 6/27/20 6/27/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 27, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia, Myeloid, Acute NCT01632852

English

Eligibility Leukemia, Myeloid, Acute NCT01632852

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female aged 18 years or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
previous diagnosis of cd123+ acute myeloid leukemia (aml), de novo or secondary.
Description

AML de novo CD123 Positive | Secondary Acute Myeloid Leukemia CD123 Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1515568
UMLS CUI [1,3]
C1416408
UMLS CUI [1,4]
C1514241
UMLS CUI [2,1]
C0280449
UMLS CUI [2,2]
C1416408
UMLS CUI [2,3]
C1514241
completed and recovered from all planned induction and consolidation therapy according to the institution's standard of care, and achieved a complete remission (cr)/cr with incomplete platelet recovery (crp); either first or second cr.
Description

Neoadjuvant Therapy Completed | Consolidation Therapy Completed | Patient recovered | In complete remission | Complete Response with Incomplete Platelet Recovery | Complete remission First | Complete remission second

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C1511484
UMLS CUI [2,2]
C0205197
UMLS CUI [3]
C1115804
UMLS CUI [4]
C0677874
UMLS CUI [5]
C3890735
UMLS CUI [6,1]
C0677874
UMLS CUI [6,2]
C0205435
UMLS CUI [7,1]
C0677874
UMLS CUI [7,2]
C0205436
has factors conferring high risk of relapse.
Description

Factor High risk of Relapse

Data type

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C0332167
UMLS CUI [1,3]
C0035020
no plans for additional post-remission chemotherapy.
Description

Absence Chemotherapy Post Remission

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0687676
UMLS CUI [1,4]
C0544452
not currently a candidate for allogeneic hematopoietic stem cell transplant (hsct).
Description

Patient Inappropriate Allogeneic hematopoietic stem cell transplant

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C4255274
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of acute promyelocytic leukemia (apl).
Description

Acute Promyelocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023487
known leukemic involvement of the central nervous system.
Description

Central Nervous System Involvement Leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0023418
life expectancy 4 months or less as estimated by the investigator.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
concurrent treatment or planned treatment with other anticancer therapy (chemotherapy, immunotherapy, radiotherapy, targeted therapy, gene therapy).
Description

Cancer treatment Other | Cancer treatment Other Planned | Chemotherapy | Immunotherapy | Therapeutic radiology procedure | Targeted Therapy | Gene therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C1301732
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0021083
UMLS CUI [5]
C1522449
UMLS CUI [6]
C2985566
UMLS CUI [7]
C0017296
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Similar models

Eligibility Leukemia, Myeloid, Acute NCT01632852

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female aged 18 years or older.
boolean
C0001779 (UMLS CUI [1])
AML de novo CD123 Positive | Secondary Acute Myeloid Leukemia CD123 Positive
Item
previous diagnosis of cd123+ acute myeloid leukemia (aml), de novo or secondary.
boolean
C0023467 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C1416408 (UMLS CUI [1,3])
C1514241 (UMLS CUI [1,4])
C0280449 (UMLS CUI [2,1])
C1416408 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
Neoadjuvant Therapy Completed | Consolidation Therapy Completed | Patient recovered | In complete remission | Complete Response with Incomplete Platelet Recovery | Complete remission First | Complete remission second
Item
completed and recovered from all planned induction and consolidation therapy according to the institution's standard of care, and achieved a complete remission (cr)/cr with incomplete platelet recovery (crp); either first or second cr.
boolean
C0600558 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1511484 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C1115804 (UMLS CUI [3])
C0677874 (UMLS CUI [4])
C3890735 (UMLS CUI [5])
C0677874 (UMLS CUI [6,1])
C0205435 (UMLS CUI [6,2])
C0677874 (UMLS CUI [7,1])
C0205436 (UMLS CUI [7,2])
Factor High risk of Relapse
Item
has factors conferring high risk of relapse.
boolean
C1521761 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C0035020 (UMLS CUI [1,3])
Absence Chemotherapy Post Remission
Item
no plans for additional post-remission chemotherapy.
boolean
C0332197 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0544452 (UMLS CUI [1,4])
Patient Inappropriate Allogeneic hematopoietic stem cell transplant
Item
not currently a candidate for allogeneic hematopoietic stem cell transplant (hsct).
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C4255274 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Acute Promyelocytic Leukemia
Item
diagnosis of acute promyelocytic leukemia (apl).
boolean
C0023487 (UMLS CUI [1])
Central Nervous System Involvement Leukemia
Item
known leukemic involvement of the central nervous system.
boolean
C4050309 (UMLS CUI [1,1])
C0023418 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy 4 months or less as estimated by the investigator.
boolean
C0023671 (UMLS CUI [1])
Cancer treatment Other | Cancer treatment Other Planned | Chemotherapy | Immunotherapy | Therapeutic radiology procedure | Targeted Therapy | Gene therapy
Item
concurrent treatment or planned treatment with other anticancer therapy (chemotherapy, immunotherapy, radiotherapy, targeted therapy, gene therapy).
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
C2985566 (UMLS CUI [6])
C0017296 (UMLS CUI [7])
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