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

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.

Inclusion criteria

• 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 criteria

• 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.