Clinical trial NCT04470947: Comprehensive Genomic Profiling and Next Generation Functional Drug Screening for Patients With Aggressive Haematological Malignancies
Official title: Comprehensive Genomic Profiling and Next Generation Functional Drug Screening for Patients With Aggressive Haematological Malignancies: Next Generation Personal Hematology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Lymphoma
Refractory Lymphoma
Refractory Leukemia
Refractory Acute Myeloid Leukemia
Refractory T-Cell Lymphoma
Keywords: Personalized medicine
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
name: Allcyte GmbH
First posted: 2020-07-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 150 patients with relapsed/ refractory acute leukemia and relapsed/ refractory aggressive lymphoma after standard treatment fulfilling inclusion criteria.

Brief 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


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of patients with a ratio ≥1.3 of progression free survival (PFS) compared to most recent treatment
timeFrame: Through study completion, an average of 8 month
Secondary outcomes:
measure: Average Ratio of PFS/PFS of most prior treatment
timeFrame: Through study completion, an average of 8 months
measure: Overall response rate (ORR)
timeFrame: Through study completion, an average of 8 months
measure: Number of treatable targets identified
timeFrame: Through study completion, an average of 8 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
citation: 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.