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
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Updated on 24 January 2021
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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 Lymphoma, Refractory Leukemia, Advanced Lymphoma, Refractory T-Cell Lymphoma, Refractory T-Cell Lymphoma, refractory acute myeloid leukemia (aml), Refractory T-Cell Lymphoma
Treatment Next generation functional drug screening, Comprehensive genomic profiling
Clinical Study IdentifierNCT04470947
SponsorMedical University of Vienna
Last Modified on24 January 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Advanced Lymphoma or Refractory Acute Myeloid Leukemia or Refractory T-Cell Lymphoma or Refractory Leukemia or Refractory Lymphoma?
Do you have any of these conditions: Refractory Leukemia or refractory acute myeloid leukemia (aml) or Refractory Acute Myeloid Leukemia or Refractory T-Cell Lymphoma or Advanced Lymphoma...?
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)
Clear my responses
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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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