Advanced Lymphoma, Refractory Acute Myeloid Leukemia, Refractory Leukemia, Refractory Lymphoma, Refractory T-Cell Lymphoma
Conditions
Keywords
Personalized medicine
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
Interventions
DIAGNOSTIC_TESTComprehensive genomic profiling
Comprehensive targeted profiling of genetic aberrations on primary patient tumor material
DIAGNOSTIC_TESTNext generation functional drug screening
High-throughput image based in-vitro drug screening on primary patient tumor cells
Sponsors
Roche Pharma AG
Allcyte GmbH
Medical University of Vienna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with a ratio ≥1.3 of progression free survival (PFS) compared to most recent treatment | Through study completion, an average of 8 month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Ratio of PFS/PFS of most prior treatment | Through study completion, an average of 8 months | Average Ratio of PFS/PFS of most prior treatment |
| Overall response rate (ORR) | Through study completion, an average of 8 months | Overall response rate (ORR) |
| Number of treatable targets identified | Through study completion, an average of 8 months | Number of treatable targets identified |
Countries
Austria
Contacts
Primary ContactPhilipp B. Staber, MD, PhD
Outcome results
None listed