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

March 20, 2024 updated by: Philipp Staber, MD, PhD, Medical University of Vienna

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Next generation functional drug screening
Diagnostic test: Next generation functional drug screening
High-throughput image based in-vitro drug screening on primary patient tumor cells
Diagnostic test: Comprehensive genomic profiling
Comprehensive targeted profiling of genetic aberrations on primary patient tumor material
Other Names:
  • FoundationOne Heme
Comprehensive genomic profiling
Diagnostic test: Next generation functional drug screening
High-throughput image based in-vitro drug screening on primary patient tumor cells
Diagnostic test: Comprehensive genomic profiling
Comprehensive targeted profiling of genetic aberrations on primary patient tumor material
Other Names:
  • FoundationOne Heme
Physician's choice
Diagnostic test: Next generation functional drug screening
High-throughput image based in-vitro drug screening on primary patient tumor cells
Diagnostic test: Comprehensive genomic profiling
Comprehensive targeted profiling of genetic aberrations on primary patient tumor material
Other Names:
  • FoundationOne Heme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with a ratio ≥1.3 of progression free survival (PFS) compared to most recent treatment
Time Frame: 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
Through study completion, an average of 8 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Ratio of PFS/PFS of most prior treatment
Time Frame: Through study completion, an average of 8 months
Average Ratio of PFS/PFS of most prior treatment
Through study completion, an average of 8 months
Overall response rate (ORR)
Time Frame: 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
Time Frame: Through study completion, an average of 8 months
Number of treatable targets identified
Through study completion, an average of 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Collaborators

Roche Pharma AG
Allcyte GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2020

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

July 7, 2020

First Submitted That Met QC Criteria

July 10, 2020

First Posted (Actual)

July 14, 2020

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FA711C1050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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