ID

42894

Description

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

Link

https://clinicaltrials.gov/show/NCT01685411

Keywords

Versions (2)
  1. 12/21/15 12/21/15 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Acute Lymphoblastic Leukemia NCT01685411

English

Eligibility Acute Lymphoblastic Leukemia NCT01685411

1 forms  
Inclusion Criteria
Description

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:
Description

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

Data type

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)
Description

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

Data type

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
Description

ineligible for total body irradiation

Data type

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
Description

karnofsky performance status

Data type

boolean

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

major organ function

Data type

boolean

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

left ventricular ejection fraction

Data type

boolean

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

creatinine clearance

Data type

boolean

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

hepatic failure

Data type

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:
Description

source of stem cells

Data type

boolean

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

related or unrelated donor

Data type

boolean

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

related or unrelated donor peripheral blood stem cells

Data type

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)
Description

related or single or double unrelated donor umbilical cord blood

Data type

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
Description

contraceptive methods, negative pregnancy test

Data type

boolean

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

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
eligible for tbi containing preparative regimen
Description

eligible for total body irradiation

Data type

boolean

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

infection

Data type

boolean

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

pregnant or breastfeeding

Data type

boolean

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

Eligibility Acute Lymphoblastic Leukemia NCT01685411

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