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

NCT ID: NCT06138990

Last Updated: 2025-05-16

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-02

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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AML, Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomised, controlled, parallel group, superiority interventional trial.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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.

Group Type EXPERIMENTAL

Pharmacoscopy

Intervention Type 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.

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).

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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.

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role collaborator

ETH Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Berend Snijder, PhD

Role: CONTACT

+41 44 633 71 49

Facility Contacts

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Thomas Pabst, Prof. Dr. med

Role: primary

+41 31 632 41 14

Alexandre Theocharides, Prof. Dr. med

Role: primary

+41 44 255 37 82

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.

Reference Type BACKGROUND
PMID: 29153976 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34635570 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37439341 (View on PubMed)

Related Links

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https://www.snijderlab.org

Snijder Lab website

Other Identifiers

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RAPID-01

Identifier Type: -

Identifier Source: org_study_id

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