Information:
Fel:
ID
17381
Beskrivning
CD19-specific T-cell for Chronic Lymphocytic Leukemia (CLL); ODM derived from: https://clinicaltrials.gov/show/NCT01653717
Länk
https://clinicaltrials.gov/show/NCT01653717
Nyckelord
Versioner (1)
- 2016-09-10 2016-09-10 -
Uppladdad den
10 september 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Advanced Cancers NCT01653717
Eligibility Advanced Cancers NCT01653717
- StudyEvent: Eligibility
Similar models
Eligibility Advanced Cancers NCT01653717
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
b-cll
Item
patients with a history of b-cll, who have received at least 2 lines of standard chemoimmunotherapy and have persistent disease.
boolean
C0023434 (UMLS CUI [1])
cd19+
Item
confirmed history of cd19 positivity by flow cytometry.
boolean
C1267885 (UMLS CUI [1])
cytotoxic chemotherapy
Item
at least 8 weeks from last cytotoxic chemotherapy. patients may continue ibrutinib or lenalidomide. these drugs will be discontinued 1 week prior to start of lymphodepleting chemotherapy.
boolean
C0677881 (UMLS CUI [1])
karnofsky
Item
karnofsky performance scale > 60%.
boolean
C0206065 (UMLS CUI [1])
absolute lymphocyte count
Item
absolute lymphocyte count >100/ul.
boolean
C3544087 (UMLS CUI [1])
hepatic function
Item
adequate hepatic function, as defined by sgpt <3 x upper limit of normal; serum bilirubin and alkaline phosphatase <2 x upper limit of normal, or considered not clinically significant by the study doctor or designee.
boolean
C0232741 (UMLS CUI [1])
informed consent
Item
able to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
age
Item
18-80 years of age.
boolean
C0001779 (UMLS CUI [1])
written informed consent
Item
patient or patient's legal representative, parent(s) or guardian able to provide written informed consent for the long-term follow-up gene therapy study.
boolean
C0021430 (UMLS CUI [1])
beta hcg positive
Item
positive beta hcg in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or lactating females.
boolean
C0813152 (UMLS CUI [1])
hypersensivity
Item
patients with known allergy to bovine or murine products.
boolean
C0020517 (UMLS CUI [1,1])
C0007452 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0591833 (UMLS CUI [2,2])
C0007452 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0591833 (UMLS CUI [2,2])
hiv+
Item
positive serology for hiv.
boolean
C0019699 (UMLS CUI [1])
steroid therapy
Item
presence of autoimmune phenomenon (aiha, itp) requiring steroid therapy.
boolean
C0149783 (UMLS CUI [1])
toxicity
Item
presence of grade 3 or greater toxicity from the previous treatment.
boolean
C0013221 (UMLS CUI [1])
investigational agents
Item
concomitant use of other investigational agents (ibrutinib or lenalidomide are allowed).
boolean
C1875319 (UMLS CUI [1])