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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
| Allcyte GmbH | INDUSTRY |
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EXALT-2 is a prospective, randomized, three arm study for treatment decision guided either by either comprehensive genomic profiling, next generation drug screening or physician's choice
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Next generation functional drug screening |
| ||
| Comprehensive genomic profiling |
| ||
| Physician's choice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Next generation functional drug screening | Diagnostic Test | High-throughput image based in-vitro drug screening on primary patient tumor cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with a ratio ≥1.3 of progression free survival (PFS) compared to most recent treatment | The study aims to identify if next-generation functional drug screening (ngFDS) and/or comprehensive genomic profiling (CGP; FoundationOne®Heme) compared to physicians' choice guided treatment will have an increased percentage of patients with a ratio ≥1.3 of progression free survival (PFS)/PFS of most recent treatment in patients with aggressive haematological malignancies | Through study completion, an average of 8 month |
| Measure | Description | Time Frame |
|---|---|---|
| Average Ratio of PFS/PFS of most prior treatment | Average Ratio of PFS/PFS of most prior treatment | Through study completion, an average of 8 months |
| Overall response rate (ORR) | Overall response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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150 patients with relapsed/ refractory acute leukemia and relapsed/ refractory aggressive lymphoma after standard treatment fulfilling inclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philipp B. Staber, MD, PhD | Contact | +43 140400 | 73782 | philipp.staber@meduniwien.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
| 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. |
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| Comprehensive genomic profiling | Diagnostic Test | Comprehensive targeted profiling of genetic aberrations on primary patient tumor material |
|
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| Through study completion, an average of 8 months |
| Number of treatable targets identified | Number of treatable targets identified | Through study completion, an average of 8 months |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D007938 | Leukemia |
| D015470 | Leukemia, Myeloid, Acute |
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |
| D007951 | Leukemia, Myeloid |
| D008228 | Lymphoma, Non-Hodgkin |
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