Pharmacoscopy-guided Clinical Standard-of-care in r/r AML
NCT ID: NCT06138990
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
88 participants
INTERVENTIONAL
2024-09-02
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
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.
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).
Clinical standard-of-care (physician's choice)
Clinical standard-of-care therapy for RR AML selected by the physician (physician's choice).
Interventions
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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.
Clinical standard-of-care (physician's choice)
Clinical standard-of-care therapy for RR AML selected by the physician (physician's choice).
Eligibility Criteria
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Inclusion Criteria
* Age 18-70 years.
* Considered to be eligible for intensive chemotherapy.
* Written informed consent.
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
ETH Zurich
OTHER
Responsible Party
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Principal Investigators
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Alexandre Theocharides, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
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Inselspital Bern
Bern, Canton of Bern, Switzerland
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Related Links
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Snijder Lab website
Other Identifiers
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RAPID-01
Identifier Type: -
Identifier Source: org_study_id
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