Pharmacoscopy-guided Clinical Standard-of-care in r/r AML (RAPID-01)

ETH Zurich

Status and phase: Enrolling; Phase 2

Conditions: AML, Adult

Treatments: Diagnostic Test: Pharmacoscopy; Drug: Clinical standard-of-care (physician's choice)

Study type: Interventional

Funder types: Other

Identifiers

NCT06138990

RAPID-01

Details and patient eligibility

About

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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Intervention arm: Pharmacoscopy-guided clinical standard-of-care

Experimental group

Description:

Patients in the PCY-guided treatment arm will receive one of the clinical standard-of-care treatments suggested by their own PCY results, and confirmed by the treating physician.

Treatment:

Diagnostic Test: Pharmacoscopy

Control arm

Active Comparator group

Description:

Patients in the control arm will be treated with clinical standard-of-care therapy for RR AML selected by the physician (physician's choice).

Treatment:

Drug: Clinical standard-of-care (physician's choice)