ID

36532

Description

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

Keywords

Versions (1)
  1. 5/20/19 5/20/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 20, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Myelodysplastic Syndromes NCT02328950

English

Eligibility Myelodysplastic Syndromes NCT02328950

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed written informed consent
Description

Informed Consent

Data type

boolean

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

Age

Data type

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
Description

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

Data type

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
Description

MYELODYSPLASTIC SYNDROME Advanced

Data type

boolean

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

Cardiac function | Left ventricular ejection fraction

Data type

boolean

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

Renal function | Liver function

Data type

boolean

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

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating females
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Study Subject Participation Status

Data type

boolean

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

Medical contraindication Investigational New Drug

Data type

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
Description

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

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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