Association of Ex Vivo Drug Response ( EVDR) and Clinical Outcome in Acute Myeloid Leukaemia (EXCYTE-2)

Launched by EXSCIENTIA AI LIMITED · Oct 16, 2024

Keywords

ClinConnect Summary

The EXCYTE-2 clinical trial is studying how well different drugs work to treat Acute Myeloid Leukemia (AML) by examining blood and bone marrow samples from patients. The researchers will use a special AI technology to test how the cancer cells respond to various treatments outside the body. This method, called Ex Vivo Drug Response (EVDR), helps to see which drugs may be most effective for individual patients based on their unique cancer characteristics. The goal is to find a strong link between how the cancer cells react to the drugs and the actual treatment outcomes for the patients, which could lead to more personalized and effective treatment plans in the future.

To participate in the trial, patients must be at least 18 years old and have a confirmed diagnosis of AML. They should have samples collected at the time of diagnosis or from specific treatment types. Participants will not need to undergo any additional treatments or interventions during the trial, but their samples will be analyzed to see how well their cancer responds to existing and experimental drugs. This trial is currently recruiting patients and aims to improve how doctors select treatments for AML, especially in cases where standard approaches may not be effective.

Gender

ALL

Eligibility 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.