Refractory Acute Myeloid Leukemia Clinical Trial
— EXALT-2Official title:
Comprehensive Genomic Profiling and Next Generation Functional Drug Screening for Patients With Aggressive Haematological Malignancies: Next Generation Personal Hematology
NCT number | NCT04470947 |
Other study ID # | FA711C1050 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 10, 2020 |
Est. completion date | March 31, 2026 |
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
Status | Recruiting |
Enrollment | 150 |
Est. completion date | March 31, 2026 |
Est. primary completion date | March 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - patient is suffering from aggressive haematological disease AND has undergone at least two lines of previous therapies AND/OR has undergone at least one previous therapy and no standard treatment is available in the specific disease setting and disease specific guidelines recommend treatment in studies. - duration of last response is less than 6 months defined as first day of last treatment to date of relapse, the response duration has to be available with dates (dd/mm/yyyy) for initiation of and relapse to previous treatment. - best response to previous treatment has to be available. - The patient is able to give written informed consent and wishes to undergo further therapy - further therapy is medically feasible - tumor cell-containing samples can be obtained Exclusion Criteria: - current participation in another experimental clinical trial - performance status does not allow participation (ECOG ? 1) - pregnancy, tested at screening - patient suffers from classical or nodular, lymphocyte predominant Hodgkins lymphoma. - other malignoma, diagnosed <1a before inclusion (except localized squamous cell carcinoma of the skin, surgically curable melanoma of the skin, basal cell carcinoma of the skin) |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna | Allcyte GmbH, Roche Pharma AG |
Austria,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Overall response rate (ORR) | Overall response rate (ORR) | Through study completion, an average of 8 months | |
Secondary | Number of treatable targets identified | Number of treatable targets identified | Through study completion, an average of 8 months |
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