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

NCT04470947 | Recruiting

• 1 other identifier: FA711C1050
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Personalized medicine

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with a ratio ≥1.3 of progression free survival (PFS) compared to most recent treatment

  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

  Through study completion, an average of 8 month

Secondary Outcomes (3)

• Average Ratio of PFS/PFS of most prior treatment

  Through study completion, an average of 8 months

• Overall response rate (ORR)

  Through study completion, an average of 8 months

• Number of treatable targets identified

  Through study completion, an average of 8 months

Study Arms (3)

Next generation functional drug screening

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

Comprehensive genomic profiling

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

Physician's choice

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

Interventions

Next generation functional drug screening DIAGNOSTIC_TEST

High-throughput image based in-vitro drug screening on primary patient tumor cells

Comprehensive genomic profiling; Next generation functional drug screening; Physician's choice

Comprehensive genomic profiling DIAGNOSTIC_TEST

Comprehensive targeted profiling of genetic aberrations on primary patient tumor material

Also known as: FoundationOne Heme

Comprehensive genomic profiling; Next generation functional drug screening; Physician's choice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

150 patients with relapsed/ refractory acute leukemia and relapsed/ refractory aggressive lymphoma after standard treatment fulfilling inclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead
• Roche Pharma AG: collaborator
• Allcyte GmbH: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (1)

• Snijder B, Vladimer GI, Krall N, Miura K, Schmolke AS, Kornauth C, Lopez de la Fuente O, Choi HS, van der Kouwe E, Gultekin S, Kazianka L, Bigenzahn JW, Hoermann G, Prutsch N, Merkel O, Ringler A, Sabler M, Jeryczynski G, Mayerhoefer ME, Simonitsch-Klupp I, Ocko K, Felberbauer F, Mullauer L, Prager GW, Korkmaz B, Kenner L, Sperr WR, Kralovics R, Gisslinger H, Valent P, Kubicek S, Jager U, Staber PB, Superti-Furga G. Image-based ex-vivo drug screening for patients with aggressive haematological malignancies: interim results from a single-arm, open-label, pilot study. Lancet Haematol. 2017 Dec;4(12):e595-e606. doi: 10.1016/S2352-3026(17)30208-9. Epub 2017 Nov 15.

  PMID: 29153976 BACKGROUND

MeSH Terms

Conditions

Lymphoma; Leukemia; Leukemia, Myeloid, Acute; Lymphoma, T-Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases; Leukemia, Myeloid; Lymphoma, Non-Hodgkin

Central Study Contacts

Philipp B. Staber, MD, PhD

CONTACT

+43 140400; philipp.staber@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Priv.-Doz. Dr.med.univ. Philipp Staber

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 14, 2020
• Study Start: June 10, 2020
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)