Information:
Error:
ID
12738
Description
Phase I Study of Adoptive Immunotherapy With Enriched and Expanded Autologous Natural Killer (NK) Cells for Patients With Ph+ Acute Lymphoblastic Leukemia (ALL); ODM derived from: https://clinicaltrials.gov/show/NCT02185781
Link
https://clinicaltrials.gov/show/NCT02185781
Keywords
Versions (1)
- 12/17/15 12/17/15 -
Uploaded on
December 17, 2015
DOI
To request one please log in.
License
Creative Commons BY 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Eligibility Acute Lymphoblastic Leukemia NCT02185781
Eligibility Acute Lymphoblastic Leukemia NCT02185781
- StudyEvent: Eligibility
Similar models
Eligibility Acute Lymphoblastic Leukemia NCT02185781
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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])
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])
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])
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])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])