Status:

RECRUITING

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

Lead Sponsor:

Medical University of Vienna

Collaborating Sponsors:

Roche Pharma AG

Allcyte GmbH

Conditions:

Advanced Lymphoma

Refractory Lymphoma

Eligibility:

All Genders

18+ years

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

  • 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

  • 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)

Key Trial Info

Start Date :

June 10 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

March 31 2026

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT04470947

Start Date

June 10 2020

End Date

March 31 2026

Last Update

March 22 2024

Active Locations (1)

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Medical University of Vienna

Vienna, Austria, 1090