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NCT06648512: EXCYTE-2
Association of Ex Vivo Drug Response ( EVDR) and Clinical Outcome in Acute Myeloid Leukaemia (EXCYTE-2)
trial testing No Interventions in Acute Myeloid Leukemia (AML) in 91 participants. Completed in 7 March 2025.
7 March 2025
Quick facts
| Lead sponsor | Exscientia AI Limited |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 91 |
| Start date | 13 May 2024 |
| Primary completion | 7 March 2025 |
| Estimated completion | 7 March 2025 |
| Sites | 3 locations across Austria, Finland, Germany |
Drugs / interventions tested
- No Interventions — full drug profile →
Conditions studied
- Acute Myeloid Leukemia (AML) — all drugs for Acute Myeloid Leukemia (AML) →
- Acute Myeloid Leukemia (AML) Relapse — all drugs for Acute Myeloid Leukemia (AML) Relapse →
Sponsor
Exscientia AI Limited — full company profile →
Who can join
18 and older, any sex, with Acute Myeloid Leukemia (AML) or Acute Myeloid Leukemia (AML) Relapse. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 patient's clinical treatment. To measure this Ex Vivo Drug Response (EVDR), Exscientia will use it's 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 e.g. 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 patient's 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 7+3 or CPX-351) or venetoclax + azacitidine and after favourable results in an interim analysis, biobanked samples from R/R AML FLT3 mutant patients, treated with Gilteritinib might be included. Key procedures include: * Viable tumour tissues (i.e. bone marrow or blood) taken prior to therapy are provided by biobanks to Exscientia's 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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
New genomic and proteomic biomarker discovery in cancer: revolutionizing diagnosis and prognostication.
Rajput M, Pandey M, Dixit R. · · 2026 · PMID 41593642 · DOI 10.1186/s12957-025-04185-3
Verify or expand the search:
- PubMed search for NCT06648512
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Exscientia AI Limited trials
Trials by the same sponsor.
- NCT06068738 — Association of Ex Vivo Drug Response (EVDR) and Clinical Outcome in Ovarian Cancer · terminated
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06648512 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Exscientia AI Limited
- Last refreshed: 26 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06648512.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing