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

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)