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| Name | Class |
|---|---|
| University of Zurich | OTHER |
| Insel Gruppe AG, University Hospital Bern | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm: Pharmacoscopy-guided clinical standard-of-care | Experimental | 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. |
|
| Control arm | Active Comparator | Patients in the control arm will be treated with clinical standard-of-care therapy for RR AML selected by the physician (physician's choice). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response (CR) rate at day 28 | day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite response rate (CR+CRh+CRi) at day 28 | day 28 | |
| Rate of patients bridged to allogeneic hematopoietic stem cell transplantation within 3 months post-treatment initiation | 3 months | |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Berend Snijder, PhD | Contact | +41 44 633 71 49 | bsnijder@ethz.ch |
| Name | Affiliation | Role |
|---|---|---|
| Alexandre Theocharides, MD PhD | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital Bern | Recruiting | Bern | Canton of Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29153976 | Background | 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. | |
| 34635570 |
| Label | URL |
|---|---|
| Snijder Lab website | View source |
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De-identified patient data will be made available upon publication of the study results in a peer-reviewed internationally recognized journal.
De-identified patient data will be made available upon publication of the study results in a peer-reviewed internationally recognized journal.
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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This is a randomised, controlled, parallel group, superiority interventional trial.
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|
| Clinical standard-of-care (physician's choice) | Drug | Clinical standard-of-care therapy for RR AML selected by the physician (physician's choice). |
|
| Treatment-related mortality within 3 months post-treatment initiation |
| 3 months |
| University Hospital Zurich | Recruiting | Zurich | Canton of Zurich | 8091 | Switzerland |
|
| Background |
| 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. |
| 37439341 | Background | 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. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |