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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date March 2024
Source Medical University of Vienna
Contact Philipp B. Staber, MD, PhD
Phone +43 140400
Email philipp.staber@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


Recruitment information / eligibility

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)

Study Design


Intervention

Diagnostic Test:
Next generation functional drug screening
High-throughput image based in-vitro drug screening on primary patient tumor cells
Comprehensive genomic profiling
Comprehensive targeted profiling of genetic aberrations on primary patient tumor material

Locations

Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (3)

Lead Sponsor Collaborator
Medical University of Vienna Allcyte GmbH, Roche Pharma AG

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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

Outcome

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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