RecruitingNCT04470947
Comprehensive Genomic Profiling and Next Generation Functional Drug Screening for Patients With Aggressive Haematological Malignancies
Comprehensive Genomic Profiling and Next Generation Functional Drug Screening for Patients With Aggressive Haematological Malignancies: Next Generation Personal Hematology
Sponsor
Medical University of Vienna
Enrollment
150 participants
Start Date
Jun 10, 2020
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria5
- 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)
Interventions
DIAGNOSTIC_TESTNext generation functional drug screening
High-throughput image based in-vitro drug screening on primary patient tumor cells
DIAGNOSTIC_TESTComprehensive genomic profiling
Comprehensive targeted profiling of genetic aberrations on primary patient tumor material
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04470947
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