Pharmacoscopy-guided Clinical Standard-of-care in r/r AML
Pharmacoscopy-guided Clinical Standard-of-care in Relapsed/Refractory Acute Myeloid Leukemia, a Randomized Phase-2 Clinical Trial
ETH Zurich
88 participants
Sep 2, 2024
INTERVENTIONAL
Conditions
Summary
With an overall survival of below 12 months, the outcome of relapsed/refractory AML (RR AML) is poor, making it a critical challenge to identify effective therapies at this stage. The RAPID-01 trial aims to show for the first time in a randomized and controlled clinical trial that Pharmacoscopy (PCY), a functional precision medicine platform, helps improve clinical standard-of-care treatment selection for patients suffering from relapsed/refractory AML.
Eligibility
Inclusion Criteria4
- Patient with refractory or relapsed AML according to ELN2022 criteria.
- Age 18-70 years.
- Considered to be eligible for intensive chemotherapy.
- Written informed consent.
Exclusion Criteria8
- Acute promyelocytic leukemia (APL) with PML-RARA or one of the other pathognomonic variant fusion genes/chromosome translocations.
- Blast crisis after chronic myeloid leukemia (CML).
- Considered not eligible for intensive chemotherapy.
- Condition of the patient does not allow to wait for PCY results (patient requires immediate treatment).
- PCY not working / patient sample did not pass the QC steps of PCY.
- Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the principal investigator may interfere with the project or affect patient compliance.
- Legal incompetence or Subjects lacking capacity to provide informed consent.
- Participation in a clinical trial with an investigational drug within the 30 days preceding and during the present investigation.
Interventions
Pharmacoscopy (PCY) is an image-based ex vivo drug testing platform developed by the Snijder lab at the ETH Zurich. PCY measures in the drug response of patient cells from small biopsies using automated microscopy and single-cell image analysis. PCY prioritizes treatments based on their specific efficacy against AML cells, while minimizing toxicity to healthy (non-malignant) cells in the patient biopsy.
Clinical standard-of-care therapy for RR AML selected by the physician (physician's choice).
Locations(2)
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NCT06138990