ID

41036

Beschreibung

A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase CML or With Ph+ Leukemias Resistant or Intolerant to Imatinib; ODM derived from: https://clinicaltrials.gov/show/NCT00777036

Link

https://clinicaltrials.gov/show/NCT00777036

Stichworte

Versionen (1)
  1. 16.06.20 16.06.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

16. Juni 2020

DOI

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Creative Commons BY 4.0
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Eligibility Leukemia NCT00777036

Englisch

Eligibility Leukemia NCT00777036

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00777036
Criteria
Beschreibung

Criteria

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
cp-cml who prove resistant or intolerant to imatinib (cohort #1)
Beschreibung

Leukemia, Myeloid, Chronic-Phase | Resistant to Imatinib | Intolerance to Imatinib

Datentyp

boolean

Alias
UMLS CUI [1]
C0023474
UMLS CUI [2,1]
C0332325
UMLS CUI [2,2]
C0935989
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0935989
ph+ all, ap-cml, or bp-cml who are resistant or intolerant to or who relapse after imatinib therapy (cohort #2)
Beschreibung

Philadelphia positive acute lymphocytic leukaemia | Leukemia, Myeloid, Accelerated Phase | Blast Phase | Resistant to Imatinib | Intolerance to Imatinib | Relapse | Status post Imatinib

Datentyp

boolean

Alias
UMLS CUI [1]
C4524071
UMLS CUI [2]
C0023472
UMLS CUI [3]
C0005699
UMLS CUI [4,1]
C0332325
UMLS CUI [4,2]
C0935989
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0935989
UMLS CUI [6]
C0035020
UMLS CUI [7,1]
C0231290
UMLS CUI [7,2]
C0935989
newly diagnosed, treatment naive cp-cml (cohort #3)
Beschreibung

Therapy naive | Chronic-Phase Myeloid Leukemia Newly Diagnosed

Datentyp

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0023474
UMLS CUI [2,2]
C1518321
lansky or karnofsky scale >50
Beschreibung

Lansky Play-Performance Status | Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C1522275
UMLS CUI [2]
C0206065
life expectancy ≥12 weeks
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
adequate hepatic and renal function
Beschreibung

Liver function | Renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
eligibility for potentially-curative therapy including hematopoietic stem-cell transplantation
Beschreibung

Eligibility Curative treatment | Eligibility Hemopoietic stem cell transplant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C1273390
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C0472699
symptomatic cns involvement (other than signs and symptoms caused by leptomeningeal disease)
Beschreibung

Central Nervous System Involvement Symptomatic | Exception Signs and Symptoms caused by Leptomeningeal disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0037088
UMLS CUI [2,3]
C0015127
UMLS CUI [2,4]
C0751297
isolated extramedullary disease
Beschreibung

Disease Extramedullary Isolated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1517060
UMLS CUI [1,3]
C0205409
prior therapy with dasatinib
Beschreibung

Prior Therapy Dasatinib

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1455147
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Ähnliche Modelle

Eligibility Leukemia NCT00777036

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00777036
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Leukemia, Myeloid, Chronic-Phase | Resistant to Imatinib | Intolerance to Imatinib
Item
cp-cml who prove resistant or intolerant to imatinib (cohort #1)
boolean
C0023474 (UMLS CUI [1])
C0332325 (UMLS CUI [2,1])
C0935989 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0935989 (UMLS CUI [3,2])
Philadelphia positive acute lymphocytic leukaemia | Leukemia, Myeloid, Accelerated Phase | Blast Phase | Resistant to Imatinib | Intolerance to Imatinib | Relapse | Status post Imatinib
Item
ph+ all, ap-cml, or bp-cml who are resistant or intolerant to or who relapse after imatinib therapy (cohort #2)
boolean
C4524071 (UMLS CUI [1])
C0023472 (UMLS CUI [2])
C0005699 (UMLS CUI [3])
C0332325 (UMLS CUI [4,1])
C0935989 (UMLS CUI [4,2])
C1744706 (UMLS CUI [5,1])
C0935989 (UMLS CUI [5,2])
C0035020 (UMLS CUI [6])
C0231290 (UMLS CUI [7,1])
C0935989 (UMLS CUI [7,2])
Therapy naive | Chronic-Phase Myeloid Leukemia Newly Diagnosed
Item
newly diagnosed, treatment naive cp-cml (cohort #3)
boolean
C0919936 (UMLS CUI [1])
C0023474 (UMLS CUI [2,1])
C1518321 (UMLS CUI [2,2])
Lansky Play-Performance Status | Karnofsky Performance Status
Item
lansky or karnofsky scale >50
boolean
C1522275 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Life Expectancy
Item
life expectancy ≥12 weeks
boolean
C0023671 (UMLS CUI [1])
Liver function | Renal function
Item
adequate hepatic and renal function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Eligibility Curative treatment | Eligibility Hemopoietic stem cell transplant
Item
eligibility for potentially-curative therapy including hematopoietic stem-cell transplantation
boolean
C1548635 (UMLS CUI [1,1])
C1273390 (UMLS CUI [1,2])
C1548635 (UMLS CUI [2,1])
C0472699 (UMLS CUI [2,2])
Central Nervous System Involvement Symptomatic | Exception Signs and Symptoms caused by Leptomeningeal disease
Item
symptomatic cns involvement (other than signs and symptoms caused by leptomeningeal disease)
boolean
C4050309 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0037088 (UMLS CUI [2,2])
C0015127 (UMLS CUI [2,3])
C0751297 (UMLS CUI [2,4])
Disease Extramedullary Isolated
Item
isolated extramedullary disease
boolean
C0012634 (UMLS CUI [1,1])
C1517060 (UMLS CUI [1,2])
C0205409 (UMLS CUI [1,3])
Prior Therapy Dasatinib
Item
prior therapy with dasatinib
boolean
C1514463 (UMLS CUI [1,1])
C1455147 (UMLS CUI [1,2])
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