ID

36532

Descrição

A 5 Day Course of Fludarabine and Cytarabine Followed by Full Intensity Allogeneic Stem Cell Transplantation (FA5-Bucy) in Treating Patients With High-risk, Recurrent or Refractory Acute Leukemia and Advanced Myelodysplastic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT02328950

Link

https://clinicaltrials.gov/show/NCT02328950

Palavras-chave

Versões (1)
  1. 20/05/2019 20/05/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

20 de maio de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Myelodysplastic Syndromes NCT02328950

Inglês

Eligibility Myelodysplastic Syndromes NCT02328950

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
aged between 0-65 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patients suffering from either refractory de novo aml/all or relapsed aml/all or patients with very high risk aml/all in cr1
Descrição

Refractory Acute Myeloid Leukemia de novo | Refractory acute lymphoid leukemia de novo | Acute myeloid leukaemia recurrent | Acute lymphocytic leukemia Recurrent | Acute Myelocytic Leukemia High risk | Acute Myelocytic Leukemia Complete remission First | Acute lymphocytic leukemia High risk | Acute lymphocytic leukemia Complete remission First

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4528668
UMLS CUI [1,2]
C1515568
UMLS CUI [2,1]
C4302097
UMLS CUI [2,2]
C1515568
UMLS CUI [3]
C1142169
UMLS CUI [4,1]
C0023449
UMLS CUI [4,2]
C2945760
UMLS CUI [5,1]
C0023467
UMLS CUI [5,2]
C4319571
UMLS CUI [6,1]
C0023467
UMLS CUI [6,2]
C0677874
UMLS CUI [6,3]
C0205435
UMLS CUI [7,1]
C0023449
UMLS CUI [7,2]
C4319571
UMLS CUI [8,1]
C0023449
UMLS CUI [8,2]
C0677874
UMLS CUI [8,3]
C0205435
patients with advanced mds
Descrição

MYELODYSPLASTIC SYNDROME Advanced

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3463824
UMLS CUI [1,2]
C0205179
cardiac: left ventricular ejection fraction ≥ 50%
Descrição

Cardiac function | Left ventricular ejection fraction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0428772
adequate renal and hepatic function
Descrição

Renal function | Liver function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
performance status: karnofsky ≥ 70%
Descrição

Karnofsky Performance Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0206065
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating females
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
current participation in another clinical trial
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
contra-indication to one of the drug of the regimen
Descrição

Medical contraindication Investigational New Drug

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo the agents included in the conditioning regimen
Descrição

Comorbidity Severe | Investigational New Drugs At risk | Organ dysfunction Serious | Disease Serious | Heart Disease | Kidney Disease | Liver disease | Organ system Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C1444641
UMLS CUI [3,1]
C0349410
UMLS CUI [3,2]
C0205404
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205404
UMLS CUI [5]
C0018799
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0023895
UMLS CUI [8,1]
C0460002
UMLS CUI [8,2]
C0012634
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Similar models

Eligibility Myelodysplastic Syndromes NCT02328950

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
aged between 0-65 years
boolean
C0001779 (UMLS CUI [1])
Refractory Acute Myeloid Leukemia de novo | Refractory acute lymphoid leukemia de novo | Acute myeloid leukaemia recurrent | Acute lymphocytic leukemia Recurrent | Acute Myelocytic Leukemia High risk | Acute Myelocytic Leukemia Complete remission First | Acute lymphocytic leukemia High risk | Acute lymphocytic leukemia Complete remission First
Item
patients suffering from either refractory de novo aml/all or relapsed aml/all or patients with very high risk aml/all in cr1
boolean
C4528668 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C4302097 (UMLS CUI [2,1])
C1515568 (UMLS CUI [2,2])
C1142169 (UMLS CUI [3])
C0023449 (UMLS CUI [4,1])
C2945760 (UMLS CUI [4,2])
C0023467 (UMLS CUI [5,1])
C4319571 (UMLS CUI [5,2])
C0023467 (UMLS CUI [6,1])
C0677874 (UMLS CUI [6,2])
C0205435 (UMLS CUI [6,3])
C0023449 (UMLS CUI [7,1])
C4319571 (UMLS CUI [7,2])
C0023449 (UMLS CUI [8,1])
C0677874 (UMLS CUI [8,2])
C0205435 (UMLS CUI [8,3])
MYELODYSPLASTIC SYNDROME Advanced
Item
patients with advanced mds
boolean
C3463824 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Cardiac function | Left ventricular ejection fraction
Item
cardiac: left ventricular ejection fraction ≥ 50%
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Renal function | Liver function
Item
adequate renal and hepatic function
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Karnofsky Performance Status
Item
performance status: karnofsky ≥ 70%
boolean
C0206065 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status
Item
current participation in another clinical trial
boolean
C2348568 (UMLS CUI [1])
Medical contraindication Investigational New Drug
Item
contra-indication to one of the drug of the regimen
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Comorbidity Severe | Investigational New Drugs At risk | Organ dysfunction Serious | Disease Serious | Heart Disease | Kidney Disease | Liver disease | Organ system Disease
Item
any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo the agents included in the conditioning regimen
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0349410 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0018799 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0460002 (UMLS CUI [8,1])
C0012634 (UMLS CUI [8,2])
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