Comprehensive Genomic Profiling and Next Generation Functional Drug Screening for Patients With Aggressive Haematological Malignancies

Refractory Acute Myeloid Leukemia Clinical Trial

— EXALT-2  

Official title:

Comprehensive Genomic Profiling and Next Generation Functional Drug Screening for Patients With Aggressive Haematological Malignancies: Next Generation Personal Hematology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04470947
• Other study ID #: FA711C1050
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Advanced Lymphoma
• Hematologic Neoplasms
• Leukemia
• Lymphoma
• Refractory Acute Myeloid Leukemia
• Refractory Leukemia
• Refractory Lymphoma
• Refractory T-Cell Lymphoma

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