Evaluating drug response in acute myeloid leukemia patients using biobanked samples
Prospective Analysis of the Association of Drug Activity Measured in Viable Tumour Tissues ex Vivo and Clinical Response in Acute Myeloid Leukaemia (EXCYTE-2)
This study is testing how well different cancer drugs work on leukemia cells from patients to help find better personalized treatments for acute myeloid leukemia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 142 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Exscientia AI Limited Industry-sponsored |
| Drugs / interventions | Gilteritinib |
| Locations | 3 sites (Graz and 2 other locations) |
| Trial ID | NCT06648512 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study analyzes biobanked bone marrow and blood samples from patients with acute myeloid leukemia (AML) to assess the effectiveness of various drugs on cancer cells outside the body. Using an AI-based precision medicine platform, the study measures the ex vivo drug response by exposing cancer cells to different approved or experimental AML drugs and determining the rate of cell death. The findings will be correlated with the clinical outcomes of the patients' treatments to enhance understanding of drug efficacy. The study aims to improve personalized treatment strategies for AML patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of AML who have provided consent for sample use.
Not a fit: Patients who do not have a recent sample or those with AML types not included in the study criteria may not benefit.
Why it matters
Potential benefit: If successful, this study could lead to more effective, personalized treatment options for patients with acute myeloid leukemia.
How similar studies have performed: Other studies utilizing ex vivo drug response assessments in hematological malignancies have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 18 years or older. 2. Signed informed consent form that permits use of sample in the proposed study (including permission for genetic analysis). 3. Sample of a newly diagnosed patient (sample at time point diagnosis); after interim analysis the population may include samples from patients with FLT3 mutated relapsed/refractory AML. 4. The sample may not be older than 5/ 10 years (depending on location) 5. Confirmed diagnosed AML according to WHO or ICC criteria; after interim analysis the population may include FLT3 mutated R/R AML according to ELN 2022 criteria after interim analysis. 6. Patient received one of the following therapies after sampling for which response data is available: 1. 7 + 3 (with or without additional GO or TKIs) 2. CPX-351 3. Venetoclax and AZA in combination or alone 4. If R/R AML, FLT3 mutated: treated with Gilteritinib 7. Characteristics of sample taken prior to therapy as specified in the study protocol. 8. Availability of complete dataset as specified in the study protocol. Exclusion Criteria: 1. Known or suspected HIV or active Hepatitis B and/or C infection or active COVID-19 infection (if information not available, samples can still be included) at time of sample collection. 2. Known active infection of bone marrow. 3. Known pregnancy. 4. Received systemic anticancer treatment or radiotherapy within 4 weeks of sampling (pre-treatment of hydroxyurea and/or low dose cytarabine allowed). 5. Patient is diagnosed with Acute Promyelocytic Leukaemia (APL). 6. Patients with treatment for any other oncologic neoplasm at time of sample collection. 7. Patients for whom CR could not be assessed (e.g. death before re-staging). 8. Inclusion of samples from the same patient at both diagnosis and relapse is not permitted. In such cases, only the diagnostic sample is to be used.
Where this trial is running
Graz and 2 other locations
- Medizinische Universität Graz — Graz, Austria (Recruiting)
- FHRB (Finnish Hematology Registry and Clinical Biobank) — Vantaa, Finland (Not_yet_recruiting)
- Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Hämatologie und Onkologie — Berlin, Germany (Not_yet_recruiting)
Study contacts
- Study coordinator: Claudia Baumgaertler
- Email: cbaumgaertler@exscientia.co.uk
- Phone: +43 664 160 1893
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.