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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04470947
Recruitment Status : Recruiting
First Posted : July 14, 2020
Last Update Posted : July 14, 2020
Sponsor:
Collaborators:
Roche Pharma AG
Allcyte GmbH
Information provided by (Responsible Party):
Philipp Staber, MD, PhD, Medical University of Vienna

Study Description
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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

Condition or disease Intervention/treatment
Advanced Lymphoma Refractory Lymphoma Refractory Leukemia Refractory Acute Myeloid Leukemia Refractory T-Cell Lymphoma Diagnostic Test: Next generation functional drug screening Diagnostic Test: Comprehensive genomic profiling

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 8 Months
Official Title: Comprehensive Genomic Profiling and Next Generation Functional Drug Screening for Patients With Aggressive Haematological Malignancies: Next Generation Personal Hematology
Actual Study Start Date : June 10, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Groups and Cohorts
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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 Name: 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 Name: 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 Name: FoundationOne Heme


Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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

  2. Overall response rate (ORR) [ Time Frame: Through study completion, an average of 8 months ]
    Overall response rate (ORR)

  3. Number of treatable targets identified [ Time Frame: Through study completion, an average of 8 months ]
    Number of treatable targets identified


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04470947


Contacts
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Contact: Philipp B. Staber, MD, PhD +43 140400 ext 73782 philipp.staber@meduniwien.ac.at

Locations
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Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Philipp B. Staber, MD, PhD    +43 140400 ext 73782    philipp.staber@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
Roche Pharma AG
Allcyte GmbH
More Information
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Publications:

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Responsible Party: Philipp Staber, MD, PhD, Assoc. Prof. Priv.-Doz. Dr.med.univ. Philipp Staber, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04470947    
Other Study ID Numbers: FA711C1050
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Philipp Staber, MD, PhD, Medical University of Vienna:
Personalized medicine
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Hematologic Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Hematologic Diseases