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Recruiting NCT06138990

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

Phase II Interventional AML, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pharmacoscopy, Clinical standard-of-care (physician's choice).
Who it may be relevant to
Registry conditions: AML, Adult. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Diagnostic test Pharmacoscopy
    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.
  • Drug Clinical standard-of-care (physician's choice)
    Clinical standard-of-care therapy for RR AML selected by the physician (physician's choice).

Primary outcome measures

  • Complete response (CR) rate at day 28 [Time frame: day 28]
Secondary outcome measures (3)
  • Composite response rate (CR+CRh+CRi) at day 28 [Time frame: day 28]
  • Rate of patients bridged to allogeneic hematopoietic stem cell transplantation within 3 months post-treatment initiation [Time frame: 3 months]
  • Treatment-related mortality within 3 months post-treatment initiation [Time frame: 3 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Switzerland · 2 centers
  • Inselspital Bern — Bern
  • University Hospital Zurich — Zurich

Publications

  • Snijder B, Vladimer GI, Krall N, Miura K, Schmolke AS, Kornauth C, Lopez de la Fuente O, Choi HS, van der Kouwe E, Gultekin S, Kazianka L, Bigenzahn JW, Hoermann G, Prutsch N, Merkel O, Ringler A, Sabler M, Jeryczynski G, Mayerhoefer ME, Simonitsch-Klupp I, Ocko K, Felberbauer F, Mullauer L, Prager GW, Korkmaz B, Kenner L, Sperr WR, Kralovics R, Gisslinger H, Valent P, Kubicek S, Jager U, Staber P PMID 29153976
  • Kornauth C, Pemovska T, Vladimer GI, Bayer G, Bergmann M, Eder S, Eichner R, Erl M, Esterbauer H, Exner R, Felsleitner-Hauer V, Forte M, Gaiger A, Geissler K, Greinix HT, Gstottner W, Hacker M, Hartmann BL, Hauswirth AW, Heinemann T, Heintel D, Hoda MA, Hopfinger G, Jaeger U, Kazianka L, Kenner L, Kiesewetter B, Krall N, Krajnik G, Kubicek S, Le T, Lubowitzki S, Mayerhoefer ME, Menschel E, Merkel PMID 34635570
  • Schmid JA, Festl Y, Severin Y, Bacher U, Kronig MN, Snijder B, Pabst T. Efficacy and feasibility of pharmacoscopy-guided treatment for acute myeloid leukemia patients who have exhausted all registered therapeutic options. Haematologica. 2024 Feb 1;109(2):617-621. doi: 10.3324/haematol.2023.283224. No abstract available. PMID 37439341

Identifiers

NCT: NCT06138990 · RAPID-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗