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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    150
  • sponsor
    Medical University of Vienna
Updated on 19 February 2024
cancer
basal cell carcinoma of the skin
melanoma of the skin

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

Details
Condition Refractory Acute Myeloid Leukemia, Refractory Leukemia, Advanced Lymphoma, Refractory Lymphoma, Refractory T-Cell Lymphoma
Age 18-100 years
Treatment Next generation functional drug screening, Comprehensive genomic profiling
Clinical Study IdentifierNCT04470947
SponsorMedical University of Vienna
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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