Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648512
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Association of Ex Vivo Drug Response EVDR and Clinical Outcome in Acute Myeloid Leukaemia EXCYTE-2
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Analysis of the Association of Drug Activity Measured in Viable Tumour Tissues ex Vivo and Clinical Response in Acute Myeloid Leukaemia EXCYTE-2
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXCYTE-2
Brief Summary:
This is a multicentre study on biobanked bone marrow and blood samples of AML patients conducted by Exscientia GmbH The study aims to compare the drug response measured ex vivo this means outside of the body in the samples and the documented outcome of the respective patients clinical treatment To measure this Ex Vivo Drug Response EVDR Exscientia will use its AI- Artificial Intelligence-based precision medicine platform In this platform the cells of each sample are split and distributed in a number of small vials to which different approved or experimental AML drugs are added The cells are left with the drugs for a certain period of time no culturing or expansion is done After that the cells are stained coloured by using specific dyes and the rates of dead cancer cells in each of these small vials is determined via automated microscopy The EVDR shows how well the drugs killed the cancer cells in the sample Taking clinical data into account which is information on eg the patients health status or genetic markers the EVDR could reveal which patients might especially benefit from the treatment
If a reproducible correlation between the EVDR and the patients clinical treatment outcome is found the scFDS platform could be used in the future to improve treatment selection for AML patients
The study will include biobanked samples from newly diagnosed patients treated with cytarabine daunorubicin classical 73 or CPX-351 or venetoclax azacitidine and after favourable results in an interim analysis biobanked samples from RR AML FLT3 mutant patients treated with Gilteritinib might be included
Key procedures include
Viable tumour tissues ie bone marrow or blood taken prior to therapy are provided by biobanks to Exscientias central lab or delegated central laboratory
Ex vivo drug response against commonly given standard of care drugs is evaluated in viable tumour tissues Exscientia-owned drug candidates might be included in the assay for pre-clinical testing
Clinical patient data are collected
Relationship of EVDR to clinical response is evaluated
Primary key hypothesis Ex vivo drug response EVDR is significantly associated with Complete Response CR
Secondary key hypothesis EVDR predicts achieving CR with 80 sensitivity and specificity
The outcome of this observational clinical study will have broad implications both for the clinical routine preclinical drug development and translational cancer research If a robust correlation between drug response measured ex vivo in tumour samples and clinical outcome can be identified this will pave the way for
the use of functional drug testing as a tool for personalised treatment decision making in the clinical routine in particular where classical molecular precision medicine approaches fail to prioritise effective therapies and
the use of human tumour samples as clinically relevant model systems for preclinical development of new drugs and translational cancer research that can potentially overcome the limited clinical relevance of mouse and other animal models
If a reproducible correlation between the EVDR and the patients clinical treatment outcome is found the scFDS platform could be used in the future to improve treatment selection for AML patients
The study will include biobanked samples from newly diagnosed patients treated with cytarabine daunorubicin classical 73 or CPX-351 or venetoclax azacitidine and after favourable results in an interim analysis biobanked samples from RR AML FLT3 mutant patients treated with Gilteritinib might be included
Key procedures include
Viable tumour tissues ie bone marrow or blood taken prior to therapy are provided by biobanks to Exscientias central lab or delegated central laboratory
Ex vivo drug response against commonly given standard of care drugs is evaluated in viable tumour tissues Exscientia-owned drug candidates might be included in the assay for pre-clinical testing
Clinical patient data are collected
Relationship of EVDR to clinical response is evaluated
Primary key hypothesis Ex vivo drug response EVDR is significantly associated with Complete Response CR
Secondary key hypothesis EVDR predicts achieving CR with 80 sensitivity and specificity
The outcome of this observational clinical study will have broad implications both for the clinical routine preclinical drug development and translational cancer research If a robust correlation between drug response measured ex vivo in tumour samples and clinical outcome can be identified this will pave the way for
the use of functional drug testing as a tool for personalised treatment decision making in the clinical routine in particular where classical molecular precision medicine approaches fail to prioritise effective therapies and
the use of human tumour samples as clinically relevant model systems for preclinical development of new drugs and translational cancer research that can potentially overcome the limited clinical relevance of mouse and other animal models
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None