Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06138990

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

AML, Adult Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Inselspital Bern, Bern, Canton of Bern, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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

Study contacts

Contact information is provided by the study sponsor or research team.

Berend Snijder, PhD

CONTACT

[email protected]

+41 44 633 71 49

Sponsors and collaborators

Lead sponsor

ETH Zurich

Other

Collaborators

  • Insel Gruppe AG, University Hospital Bern
  • University of Zurich

Registry information

Official study title

Pharmacoscopy-guided Clinical Standard-of-care in Relapsed/Refractory Acute Myeloid Leukemia, a Randomized Phase-2 Clinical Trial

Acronym: RAPID-01

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2023
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.