Eligibility Acute Lymphoblastic Leukemia NCT02185781

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult subjects with ph+ all in chr (1st or 2nd) with mrd positivity confirmed at baseline, older or equal to 60 years or not eligible for other post-chr treatment modalities.
Description

ph+ all

Data type

boolean

Alias
UMLS CUI [1]
C1960397
who score 0-1.
Description

who score 0-1

Data type

boolean

Alias
UMLS CUI [1]
C1298651
hematopoietic, liver and renal normal functions defined as follows:wbc bigger or equal to 2.000/mm3 lymphocytes bigger or equal to 500/mm3 neutrophils bigger or equal to 1.000/mm3 platelets bigger or equal to 50.000/mm3 hb bigger or equal to 9 g/dl creatinine fewer or equal to 1.5 x uln bilirubin fewer or equal to 1.5 x uln ast and alt less than 3 times the upper limit of normal. ldh less than 2 times the upper limit of normal.
Description

hematopoietic, liver and renal normal functions

Data type

boolean

Alias
UMLS CUI [1]
C1620290
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
for male and female subjects of childbearing potential, agreement to use effective contraception.
Description

effective contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
authorization by istituto superiore di sanità€ (iss) according to dm 2 march 2004.
Description

authorization

Data type

boolean

Alias
UMLS CUI [1,1]
C0680281
UMLS CUI [1,2]
C0018724
signed written informed consent according to ich/eu/gcp and national local regulations.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
concurrent chemotherapy or immunotherapy (tki maintenance is permitted).
Description

concomitant therapy

Data type

boolean

Alias
UMLS CUI [1]
C1707479
any contraindications to perform a leukapheretic procedure for mononuclear cell collection.
Description

contraindication

Data type

boolean

Alias
UMLS CUI [1]
C1301624
active or chronic infection, including treponema, hiv, hbv and/or hcv unless antigen/pcr negative.
Description

infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
presence of autoimmune symptoms.
Description

autoimmune symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0004364
pregnant or lactating females.
Description

pregnant or breastfeeding

Data type

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
simultaneous participation in another clinical trial.
Description

Study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
any physical or psychological impediment in a patient that could lead the investigator to suspect his/her poor compliance to the protocol.
Description

any physical or psychological impediment in a patient that could lead the investigator to suspect his/her poor compliance to the protocol.

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488

Similar models

Eligibility Acute Lymphoblastic Leukemia NCT02185781

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ph+ all
Item
adult subjects with ph+ all in chr (1st or 2nd) with mrd positivity confirmed at baseline, older or equal to 60 years or not eligible for other post-chr treatment modalities.
boolean
C1960397 (UMLS CUI [1])
who score 0-1
Item
who score 0-1.
boolean
C1298651 (UMLS CUI [1])
hematopoietic, liver and renal normal functions
Item
hematopoietic, liver and renal normal functions defined as follows:wbc bigger or equal to 2.000/mm3 lymphocytes bigger or equal to 500/mm3 neutrophils bigger or equal to 1.000/mm3 platelets bigger or equal to 50.000/mm3 hb bigger or equal to 9 g/dl creatinine fewer or equal to 1.5 x uln bilirubin fewer or equal to 1.5 x uln ast and alt less than 3 times the upper limit of normal. ldh less than 2 times the upper limit of normal.
boolean
C1620290 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
effective contraception
Item
for male and female subjects of childbearing potential, agreement to use effective contraception.
boolean
C0700589 (UMLS CUI [1])
authorization
Item
authorization by istituto superiore di sanità€ (iss) according to dm 2 march 2004.
boolean
C0680281 (UMLS CUI [1,1])
C0018724 (UMLS CUI [1,2])
informed consent
Item
signed written informed consent according to ich/eu/gcp and national local regulations.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
concomitant therapy
Item
concurrent chemotherapy or immunotherapy (tki maintenance is permitted).
boolean
C1707479 (UMLS CUI [1])
contraindication
Item
any contraindications to perform a leukapheretic procedure for mononuclear cell collection.
boolean
C1301624 (UMLS CUI [1])
infection
Item
active or chronic infection, including treponema, hiv, hbv and/or hcv unless antigen/pcr negative.
boolean
C0009450 (UMLS CUI [1])
autoimmune symptoms
Item
presence of autoimmune symptoms.
boolean
C0004364 (UMLS CUI [1])
pregnant or breastfeeding
Item
pregnant or lactating females.
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study subject participation status
Item
simultaneous participation in another clinical trial.
boolean
C2348568 (UMLS CUI [1])
any physical or psychological impediment in a patient that could lead the investigator to suspect his/her poor compliance to the protocol.
Item
any physical or psychological impediment in a patient that could lead the investigator to suspect his/her poor compliance to the protocol.
boolean
C1321605 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])