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

Recruiting

• Conditions: Advanced Lymphoma; Refractory T-Cell Lymphoma; Refractory Lymphoma; Refractory Leukemia; Refractory Acute Myeloid Leukemia
• Interventions: Diagnostic Test: Next generation functional drug screening; Diagnostic Test: Comprehensive genomic profiling

• Registration Number: NCT04470947
• Lead Sponsor: Medical University of Vienna

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-10
• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-07-10
• Study First Posted: 2020-07-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Physician's choice	Next generation functional drug screening	-
Next generation functional drug screening	Next generation functional drug screening	-
Next generation functional drug screening	Comprehensive genomic profiling	-
Comprehensive genomic profiling	Next generation functional drug screening	-
Comprehensive genomic profiling	Comprehensive genomic profiling	-
Physician's choice	Comprehensive genomic profiling	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients with a ratio ≥1.3 of progression free survival (PFS) compared to most recent treatment	Through study completion, an average of 8 month	The study aims to identify if next-generation functional drug screening (ngFDS) and/or comprehensive genomic profiling (CGP; FoundationOne®Heme) compared to physicians' choice guided treatment will have an increased percentage of patients with a ratio; ≥1.3 of progression free survival (PFS)/PFS of most recent treatment in patients with aggressive haematological malignancies

Secondary Outcome Measures

Name	Time	Method
Average Ratio of PFS/PFS of most prior treatment	Through study completion, an average of 8 months	Average Ratio of PFS/PFS of most prior treatment
Overall response rate (ORR)	Through study completion, an average of 8 months	Overall response rate (ORR)
Number of treatable targets identified	Through study completion, an average of 8 months	Number of treatable targets identified

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria