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Pharmacoscopy-guided Clinical Standard-of-care in r/r AML

ConditionAML, Adult
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorETH Zurich

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient with refractory or relapsed AML according to ELN2022 criteria.

Age 18-70 years.

Considered to be eligible for intensive chemotherapy.

Written informed consent.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pharmacoscopy

    Diagnostic test

    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 (physician's choice)

    Drug

    Clinical standard-of-care therapy for RR AML selected by the physician (physician's choice).

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Intervention arm: Pharmacoscopy-guided clinical standard-of-careExperimental treatment 1 intervention
Group B: Control armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Complete response (CR) rate at day 28

Time frame
day 28

Secondary outcomes

1

Composite response rate (CR+CRh+CRi) at day 28

Time frame
day 28
2

Rate of patients bridged to allogeneic hematopoietic stem cell transplantation within 3 months post-treatment initiation

Time frame
3 months
3

Treatment-related mortality within 3 months post-treatment initiation

Time frame
3 months

Other outcomes

Sponsors and contacts

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ETH Zurich

Lead sponsor

University of Zurich

Collaborator

Insel Gruppe AG, University Hospital Bern

Collaborator

Source ClinicalTrials.gov
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