ClinicalTrials.gg
RecruitingNCT06138990RAPID-01Updated May 16, 2025

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

A Phase 2 interventional study of Pharmacoscopy and Clinical standard-of-care (physician's choice) in AML, Adult, sponsored by ETH Zurich. Recruiting at 2 sites in Switzerland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by ETH Zurich · Phase 2, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Sep 2024; still recruiting 2 years 2 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • AML, Adult

Keywords

  • relapsed / refractory AML
  • Pharmacoscopy
  • Functional precision medicine
03

In context

Leukemia, Myeloid, Acute

3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.

This study's planned enrollment of 88 is above the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.

Browse Leukemia, Myeloid, Acute studies →

Lead sponsor

ETH Zurich is the lead sponsor of 20 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient with or relapsed AML according to ELN2022 criteria.
  • Age 18-70 years.
  • Considered to be eligible for intensive chemotherapy.
  • Written .

Exclusion criteria

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 .
  • Participation in a clinical trial with an drug within the 30 days preceding and during the present investigation.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
88 participants (estimated)

Study arms

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

    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.

    Diagnostic Test: Pharmacoscopy

  • Active comparator
    Control arm

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

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

Interventions

  • Diagnostic testPharmacoscopy

    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.

  • DrugClinical standard-of-care (physician's choice)

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

06

What researchers measure

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

07

Study locations

2 of 2 sites recruiting
08

References and documents

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 PB, Superti-Furga G. Image-based ex-vivo drug screening for patients with aggressive haematological malignancies: interim results from a single-arm, open-label, pilot study. Lancet Haematol. 2017 Dec;4(12):e595-e606. doi: 10.1016/S2352-3026(17)30208-9. Epub 2017 Nov 15. PubMed 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 O, Miura K, Mullauer L, Neumeister P, Noesslinger T, Ocko K, Ohler L, Panny M, Pichler A, Porpaczy E, Prager GW, Raderer M, Ristl R, Ruckser R, Salamon J, Schiefer AI, Schmolke AS, Schwarzinger I, Selzer E, Sillaber C, Skrabs C, Sperr WR, Srndic I, Thalhammer R, Valent P, van der Kouwe E, Vanura K, Vogt S, Waldstein C, Wolf D, Zielinski CC, Zojer N, Simonitsch-Klupp I, Superti-Furga G, Snijder B, Staber PB. Functional Precision Medicine Provides Clinical Benefit in Advanced Aggressive Hematologic Cancers and Identifies Exceptional Responders. Cancer Discov. 2022 Feb;12(2):372-387. doi: 10.1158/2159-8290.CD-21-0538. Epub 2021 Oct 11. PubMed 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. PubMed 37439341 ↗

Individual participant data

Plan to share: Yes — De-identified patient data will be made available upon publication of the study results in a peer-reviewed internationally recognized journal.

Supporting information: Clinical study report

Time frame: De-identified patient data will be made available upon publication of the study results in a peer-reviewed internationally recognized journal.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2024 (actual). Primary completion is estimated for Jun 2026, 21 months after the start.

Of 385 non-industry phase 2 interventional studies under Leukemia, Myeloid, Acute, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 108. This study's planned 21 months is below that.

Counting every sponsor, half of 442 studies reached it within 60 months; a quarter within 38 and three quarters within 104.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 14, 2023
First posted
Nov 18, 2023
StartActual
Sep 2, 2024
Primary completionEst.
Jun 30, 2026
CompletionEst.
Jun 30, 2026
Last update
May 16, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06138990
Lead sponsor
ETH Zurich
Responsible party
Sponsor
First posted
Nov 18, 2023
Start date
Sep 2, 2024
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
May 16, 2025

Study contacts

Berend Snijder, PhD
Contact
bsnijder@ethz.ch
+41 44 633 71 49
Alexandre Theocharides, MD PhD
principal investigator · University of Zurich

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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