Advanced LymphomaEXALT-2NCT04470947
Comprehensive Genomic Profiling and Next Generation Functional Drug Screening for Patients With Aggressive Haematological Malignancies
An observational study of Advanced Lymphoma and Refractory Lymphoma, run by Medical University of Vienna at 1 site in Austria.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Lymphoma, Refractory Lymphoma, Refractory Leukemia
- What is being tested?
- Next generation functional drug screening and Comprehensive genomic profiling
- How many people
- 150 participants
- Where
- 1 siteAustria
- Study dates
- 10 Jun 2020to 31 Mar 2026
- How long will I take part?
- 8 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 150 patients with relapsed/ refractory acute leukemia and relapsed/ refractory aggressive lymphoma after standard treatment fulfilling inclusion criteria.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Philipp B. Staber, MD, PhD, +43 140400 ext. 73782, philipp.staber@meduniwien.ac.at
About this study
Official title: 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
- Conditions
- Advanced Lymphoma, Refractory Lymphoma, Refractory Leukemia, Refractory Acute Myeloid Leukemia, Refractory T-Cell Lymphoma
- Being tested
- Next generation functional drug screening, Comprehensive genomic profiling
- Keywords
- Personalized medicine
- Medical subject headings
- Lymphoma, Leukemia, Leukemia, Myeloid, Acute, Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next generation functional drug screeningDiagnostic test
High-throughput image based in-vitro drug screening on primary patient tumor cells
Comprehensive genomic profilingDiagnostic test
Also called FoundationOne Heme
Comprehensive targeted profiling of genetic aberrations on primary patient tumor material
| Study group | Role | What they receive |
|---|---|---|
| Next generation functional drug screening | Not described Receives: Diagnostic Test: Next generation functional drug screening; Diagnostic Test: Comprehensive genomic profiling | |
| Comprehensive genomic profiling | Not described Receives: Diagnostic Test: Next generation functional drug screening; Diagnostic Test: Comprehensive genomic profiling | |
| Physician's choice | Not described Receives: Diagnostic Test: Next generation functional drug screening; Diagnostic Test: Comprehensive genomic profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 8 month
Secondary outcomes (3)
Average Ratio of PFS/PFS of most prior treatment
Average Ratio of PFS/PFS of most prior treatment
Measured: Through study completion, an average of 8 months
Overall response rate (ORR)
Overall response rate (ORR)
Measured: Through study completion, an average of 8 months
Number of treatable targets identified
Number of treatable targets identified
Measured: Through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start10 Jun 2020
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced LymphomaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, Allcyte GmbH
- Responsible party
- Principal investigator, Philipp Staber, MD, PhD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470947
- Sponsor's protocol ID
- FA711C1050
- Acronym
- EXALT-2
- Status last verified
- Mar 2024
- First submitted
- 7 Jul 2020
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29153976
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Genomic Profiling and Next Generation Functional Drug Screening for Patients With Aggressive Haematological Malignancies: Next Generation Personal Hematology
- ClinicalTrials.gov ID
- NCT04470947
- Acronym / sponsor ID
- EXALT-2 / FA711C1050
- Conditions
- Advanced Lymphoma, Refractory Lymphoma, Refractory Leukemia, Refractory Acute Myeloid Leukemia, Refractory T-Cell Lymphoma
- Keywords
- Personalized medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Roche Pharma AG, Allcyte GmbH
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 150 patients with relapsed/ refractory acute leukemia and relapsed/ refractory aggressive lymphoma after standard treatment fulfilling inclusion criteria.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Next generation functional drug screeningHigh-throughput image based in-vitro drug screening on primary patient tumor cells | Diagnostic test | Comprehensive genomic profiling, Next generation functional drug screening, Physician's choice |
| Comprehensive genomic profilingAlso: FoundationOne HemeComprehensive targeted profiling of genetic aberrations on primary patient tumor material | Diagnostic test | Comprehensive genomic profiling, Next generation functional drug screening, Physician's choice |
Primary outcome
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
3 secondary outcomes
Average Ratio of PFS/PFS of most prior treatment
Time frame: Through study completion, an average of 8 months
Overall response rate (ORR)
Time frame: Through study completion, an average of 8 months
Number of treatable targets identified
Time frame: Through study completion, an average of 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Background: PubMed 29153976Snijder 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Lymphoma and Refractory Lymphoma, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philipp B. Staber, MD, PhD (+43 140400 ext. 73782, philipp.staber@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04470947, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024; AzTrials last refreshed its copy on 28 Oct 2026.