ID

42894

Beskrivning

Busulfan and Cyclophosphamide Followed By ALLO BMT; ODM derived from: https://clinicaltrials.gov/show/NCT01685411

Länk

https://clinicaltrials.gov/show/NCT01685411

Nyckelord

Versioner (2)
  1. 2015-12-21 2015-12-21 -
  2. 2021-09-17 2021-09-17 -
Uppladdad den

17 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Acute Lymphoblastic Leukemia NCT01685411

Engelsk

Eligibility Acute Lymphoblastic Leukemia NCT01685411

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of acute lymphoblastic leukemia (all), acute myeloid leukemia (aml) or myelodysplastic syndrome (mds) and current in complete remission meeting one of the following:
Beskrivning

diagnosis of acute lymphoblastic leukemia (all), acute myeloid leukemia (aml) or myelodysplastic syndrome (mds)

Datatyp

boolean

Alias
UMLS CUI [1]
C0023449
UMLS CUI [2]
C0023467
UMLS CUI [3]
C3463824
UMLS CUI [4]
C0677874
<45 years of age who are at least 6 months after initial hematopoietic stem cell transplant (hsct)
Beskrivning

<45 years of age who are at least 6 months after initial hematopoietic stem cell transplant (hsct)

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0872291
UMLS CUI [3]
C0472699
<45 years of age and have received sufficient radiation treatment to be ineligible for total body irradiation (tbi) containing preparative therapy
Beskrivning

ineligible for total body irradiation

Datatyp

boolean

Alias
UMLS CUI [1]
C1555471
UMLS CUI [2]
C0043162
karnofsky performance status >70 percent or if <16 years of age, a lansky play score >50
Beskrivning

karnofsky performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
adequate major organ function including:
Beskrivning

major organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
cardiac: left ventricular ejection fraction >45 percent by echocardiogram (echo/muga)
Beskrivning

left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
renal: creatinine clearance >40 ml/min/1.73m^2
Beskrivning

creatinine clearance

Datatyp

boolean

Alias
UMLS CUI [1]
C0373595
hepatic: no clinical evidence of hepatic failure (e.g., coagulopathy, ascites)
Beskrivning

hepatic failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0085605
an acceptable source of stem cells according to current university of minnesota bone marrow transplant program guidelines. acceptable stem cell sources include:
Beskrivning

source of stem cells

Datatyp

boolean

Alias
UMLS CUI [1]
C0375877
hla-matched related or unrelated donor bone marrow (6/6 or 5/6 antigen match)
Beskrivning

related or unrelated donor

Datatyp

boolean

Alias
UMLS CUI [1]
C0375877
hla-matched related or unrelated donor peripheral blood stem cells
Beskrivning

related or unrelated donor peripheral blood stem cells

Datatyp

boolean

Alias
UMLS CUI [1]
C0375877
UMLS CUI [2]
C0457411
related or single or double unrelated donor umbilical cord blood (6/6, 5/6 or 4/6 match)
Beskrivning

related or single or double unrelated donor umbilical cord blood

Datatyp

boolean

Alias
UMLS CUI [1]
C3653065
UMLS CUI [2]
C0375877
women of childbearing age must have a negative pregnancy test and all sexually active participants must agree to use effective contraception during study treatment
Beskrivning

contraceptive methods, negative pregnancy test

Datatyp

boolean

Alias
UMLS CUI [1]
C0427780
UMLS CUI [2]
C0700589
written consent (adult or parent/guardian)
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
eligible for tbi containing preparative regimen
Beskrivning

eligible for total body irradiation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0043162
active uncontrolled infection within one week of study enrollment
Beskrivning

infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
pregnant or lactating female
Beskrivning

pregnant or breastfeeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
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Similar models

Eligibility Acute Lymphoblastic Leukemia NCT01685411

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
diagnosis of acute lymphoblastic leukemia (all), acute myeloid leukemia (aml) or myelodysplastic syndrome (mds)
Item
diagnosis of acute lymphoblastic leukemia (all), acute myeloid leukemia (aml) or myelodysplastic syndrome (mds) and current in complete remission meeting one of the following:
boolean
C0023449 (UMLS CUI [1])
C0023467 (UMLS CUI [2])
C3463824 (UMLS CUI [3])
C0677874 (UMLS CUI [4])
<45 years of age who are at least 6 months after initial hematopoietic stem cell transplant (hsct)
Item
<45 years of age who are at least 6 months after initial hematopoietic stem cell transplant (hsct)
boolean
C0001779 (UMLS CUI [1])
C0872291 (UMLS CUI [2])
C0472699 (UMLS CUI [3])
ineligible for total body irradiation
Item
<45 years of age and have received sufficient radiation treatment to be ineligible for total body irradiation (tbi) containing preparative therapy
boolean
C1555471 (UMLS CUI [1])
C0043162 (UMLS CUI [2])
karnofsky performance status
Item
karnofsky performance status >70 percent or if <16 years of age, a lansky play score >50
boolean
C0206065 (UMLS CUI [1])
major organ function
Item
adequate major organ function including:
boolean
C0678852 (UMLS CUI [1])
left ventricular ejection fraction
Item
cardiac: left ventricular ejection fraction >45 percent by echocardiogram (echo/muga)
boolean
C0428772 (UMLS CUI [1])
creatinine clearance
Item
renal: creatinine clearance >40 ml/min/1.73m^2
boolean
C0373595 (UMLS CUI [1])
hepatic failure
Item
hepatic: no clinical evidence of hepatic failure (e.g., coagulopathy, ascites)
boolean
C0085605 (UMLS CUI [1])
source of stem cells
Item
an acceptable source of stem cells according to current university of minnesota bone marrow transplant program guidelines. acceptable stem cell sources include:
boolean
C0375877 (UMLS CUI [1])
related or unrelated donor
Item
hla-matched related or unrelated donor bone marrow (6/6 or 5/6 antigen match)
boolean
C0375877 (UMLS CUI [1])
related or unrelated donor peripheral blood stem cells
Item
hla-matched related or unrelated donor peripheral blood stem cells
boolean
C0375877 (UMLS CUI [1])
C0457411 (UMLS CUI [2])
related or single or double unrelated donor umbilical cord blood
Item
related or single or double unrelated donor umbilical cord blood (6/6, 5/6 or 4/6 match)
boolean
C3653065 (UMLS CUI [1])
C0375877 (UMLS CUI [2])
contraceptive methods, negative pregnancy test
Item
women of childbearing age must have a negative pregnancy test and all sexually active participants must agree to use effective contraception during study treatment
boolean
C0427780 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
informed consent
Item
written consent (adult or parent/guardian)
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
eligible for total body irradiation
Item
eligible for tbi containing preparative regimen
boolean
C1548635 (UMLS CUI [1,1])
C0043162 (UMLS CUI [1,2])
infection
Item
active uncontrolled infection within one week of study enrollment
boolean
C0009450 (UMLS CUI [1])
pregnant or breastfeeding
Item
pregnant or lactating female
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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