Comprehensive Genomic Profiling and Next Generation Functional Drug Screening for Patients With Aggressive Haematological Malignancies (EXALT-2)

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Medical University of Vienna

Status

Enrolling

Conditions

Refractory Lymphoma
Refractory Leukemia
Refractory T-Cell Lymphoma
Refractory Acute Myeloid Leukemia
Advanced Lymphoma

Treatments

Diagnostic Test: Next generation functional drug screening
Diagnostic Test: Comprehensive genomic profiling

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT04470947
FA711C1050

Details and patient eligibility

About

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

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

150 participants in 3 patient groups

Next generation functional drug screening
Treatment:
Diagnostic Test: Comprehensive genomic profiling
Diagnostic Test: Next generation functional drug screening
Comprehensive genomic profiling
Treatment:
Diagnostic Test: Comprehensive genomic profiling
Diagnostic Test: Next generation functional drug screening
Physician's choice
Treatment:
Diagnostic Test: Comprehensive genomic profiling
Diagnostic Test: Next generation functional drug screening

Trial contacts and locations

1

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Central trial contact

Philipp B. Staber, MD, PhD

Data sourced from clinicaltrials.gov

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