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)

Medical University of Vienna

Vienna, Austria

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NCT04470947


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