GlioblastomaATTRACTNCT06512311
Personalized Targeted Glioblastoma Therapies by ex Vivo Drug Screening
A study testing CBMed Drug Screening Plattform in people with Glioblastoma, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Patient derived cell line (PDC) -based drug screening will be applied to formulate a personalized treatment approach. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- CBMed Drug Screening Plattform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteAustria
- Study dates
- 10 Jul 2024to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75
- ECOG performance status 0-2
- Newly diagnosed glioblastoma, IDH wildtype - according to the 2021 WHO classification of Tumors of the Central Nervous System
- MGMT promotor unmethylated per local investigator
- Tissue available for drug screening (successful PDC establishment from surgical material)
- Scheduled for concomitant radio-chemotherapy with temozolomide
- Written informed consent
Who cannot join
- Current participation in another therapeutic clinical trial
- Patients with a concurrent malignancy or malignancy within five years prior of study enrolment except for carcinoma in situ of the cervix, non-melanoma skin carcinoma or stage I uterine cancer within the last 3 years
- Pregnant or lactating women
- Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antibody [HBsAg] test and a positive anti-hepatitis B core antibody [HBcAb] test, accompanied by a negative HBV DNA test) are eligible. Patients positive for anti-HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
- Known human immunodeficiency virus (HIV) infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA, CD4+ count ≥350 cells/mm3 , no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications (meaning there are no expected further changes in that time to the number or type of antiretroviral drugs in the regimen). If an HIV infection meets the above criteria, monitoring of viral RNA load and CD4+ count is recommended.
- Any of the following co-morbidities:
Show all 16Show fewer
- Pre-existing severe peripheral neuropathy (> CTCAE grade 2)
- Hepatic impairment (Bilirubin Level >1.5x-3x ULN)
- Kidney dysfunction (CrCl < 59 mL/min)
- Cardiac dysfunction with left ventricular ejection fraction <60 %
- Any grade of interstitial lung disease
- Ongoing or previous history of rhabdomyolysis
- Acute pancreatitis
- QTcF ≥480 msec
- Diabetes mellitus with fasting glucose > 250mg/dl or 13.9 mmol/L
- Participants who are unable or unwilling to comply with the requirements of the protocol as assessed by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
AKH Vienna, Department for Internal Medicine I, Oncology
Vienna, State of Vienna, 1090
Anna Berghoff, MD, +43140400 ext. 44450, anna.berghoff@meduniwien.ac.at
Marika Rosner, +43140400 ext. 44450, marika.rosner@meduniwien.ac.at
About this study
Official title: Personalized Targeted Glioblastoma Therapies by ex Vivo Drug Screening: Advanced Brain Tumor TheRApy Clinical Trial (ATTRACT)
Patient derived cell line (PDC) -based drug screening will be applied to formulate a personalized treatment approach.
Read the detailed description
Patient derived cell line (PDC) -based drug screening will be applied to formulate a personalized treatment approach. Patients will be randomized between the investigational group receiving in addition to standard histology analysis also the PDC-based drug screening and the standard group receiving only standard histology analysis. Outcome results will be compared in a randomized, interventional clinical performance study. The PDC-based drug screening will be performed only in accordance with the approved Performance Study Plan on subjects who have signed an informed consent form.
- Conditions
- Glioblastoma
- Being tested
- CBMed Drug Screening Plattform
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBMed Drug Screening PlattformDiagnostic test
The main devices used within the drug screening process are purchased from PerkinElmer, Liconic Instruments, BioTek and Beckman Coulter Diagnostics.
| Study group | Role | What they receive |
|---|---|---|
| PDC-based drug screening | Experimental | 120 patients will be included in the intervention group and will receive PDC-based drug screening. The molecular tumor board will formulate a personalized treatment recommendation by incorporating the individual characteristics of the patients including age, co-morbidities, co-medication, and performance status in addition to the results of the PDC-based drug screening. Receives: Diagnostic Test: CBMed Drug Screening Plattform |
| Standard group | No intervention | 120 patients will be included in the standard group and will not receive PDC-based drug screening. In line, no personalized treatment approach will be formulated by the molecular tumor board and patients will all receive the recommendation for standard treatment including temozolomide maintenance therapy for 6 cycles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival time
Change in overall survival in patients receiving extensive diagnostic work up including the standard histology analysis and PDC- based drug screening in addition (interventional arm) compared to patients receiving only standard histology diagnostic work up (standard arm)
Measured: From date of randomization until date of death from any cause or last follow up whichever came first, assessed up to 144 months
Secondary outcomes (3)
Feasibility of PDC-based drug screening
Number not interpretable results of the PDC-based drug screening; Number of interpretable results of the PDC-based drug screening
Measured: From date of randomization until date of communication of the tumor board outcome, asses up to 144 months
Comparison of Quality of life measurements
Difference between the interventional and the standard arm using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ- C30) and the brain cancer specific questionnaire (QLQ-BN20). The scale is from 0 to 100, with higher values reporting better quality of life.
Measured: From date of randomization until date of death from any cause or last follow up whichever came first, assessed up to 144 months
Comparison of neurocognitive function scale
differences in neurocognitive function between the interventional and standard arms using the Neurologic Assessment in Neuro-Oncology (NANO) scale
Measured: From date of randomization until date of death from any cause or last follow up whichever came first, assessed up to 144 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start10 Jul 2024
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (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 GlioblastomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Berghoff, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512311
- Sponsor's protocol ID
- ATTRACT
- Acronym
- ATTRACT
- Status last verified
- Sep 2025
- First submitted
- 10 Jul 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Berghoff AS, Mair MJ, Spiro Z, Abdel Malak C, El-Heliebi A, Eckert F, Furtner J, Konig F, Leibetseder A, Nowosielski M, Oberndorfer S, Prietl B, Pichler J, Pieber TR, Spiegl-Kreinecker S, Urbanic Purkart T, Wohrer A, Widhalm G, Preusser M; ATTRACT study group. Personalized targeted glioblastoma therapies by ex vivo drug screening: Study protocol of the Advanced brain Tumor TheRApy Clinical Trial (ATTRACT). Neurooncol Adv. 2025 Mar 7;7(1):vdaf056. doi: 10.1093/noajnl/vdaf056. eCollection 2025 Jan-Dec.
PubMed 40351832
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Targeted Glioblastoma Therapies by ex Vivo Drug Screening: Advanced Brain Tumor TheRApy Clinical Trial (ATTRACT)
- ClinicalTrials.gov ID
- NCT06512311
- Acronym / sponsor ID
- ATTRACT / ATTRACT
- Conditions
- Glioblastoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 22 Jul 2024 (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.
Patient derived cell line (PDC) -based drug screening will be applied to formulate a personalized treatment approach.
Detailed description
Patient derived cell line (PDC) -based drug screening will be applied to formulate a personalized treatment approach. Patients will be randomized between the investigational group receiving in addition to standard histology analysis also the PDC-based drug screening and the standard group receiving only standard histology analysis. Outcome results will be compared in a randomized, interventional clinical performance study. The PDC-based drug screening will be performed only in accordance with the approved Performance Study Plan on subjects who have signed an informed consent form.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDC-based drug screening | Experimental | Diagnostic Test: CBMed Drug Screening Plattform120 patients will be included in the intervention group and will receive PDC-based drug screening. The molecular tumor board will formulate a personalized treatment recommendation by incorporating the individual characteristics of the patients including age, co-morbidities, co-medication, and performance status in addition to the results of the PDC-based drug screening. |
| Standard group | No intervention | –120 patients will be included in the standard group and will not receive PDC-based drug screening. In line, no personalized treatment approach will be formulated by the molecular tumor board and patients will all receive the recommendation for standard treatment including temozolomide maintenance therapy for 6 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75
- ECOG performance status 0-2
- Newly diagnosed glioblastoma, IDH wildtype - according to the 2021 WHO classification of Tumors of the Central Nervous System
- MGMT promotor unmethylated per local investigator
- Tissue available for drug screening (successful PDC establishment from surgical material)
Key exclusion criteria (16 listed)
- Current participation in another therapeutic clinical trial
- Patients with a concurrent malignancy or malignancy within five years prior of study enrolment except for carcinoma in situ of the cervix, non-melanoma skin carcinoma or stage I uterine cancer within the last 3 years
- Pregnant or lactating women
- Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antibody [HBsAg] test and a positive anti-hepatitis B core antibody [HBcAb] test, accompanied by a negative HBV DNA test) are eligible. Patients positive for anti-HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
- Known human immunodeficiency virus (HIV) infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA, CD4+ count ≥350 cells/mm3 , no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications (meaning there are no expected further changes in that time to the number or type of antiretroviral drugs in the regimen). If an HIV infection meets the above criteria, monitoring of viral RNA load and CD4+ count is recommended.
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 |
|---|---|---|
| CBMed Drug Screening PlattformThe main devices used within the drug screening process are purchased from PerkinElmer, Liconic Instruments, BioTek and Beckman Coulter Diagnostics. | Diagnostic test | PDC-based drug screening |
Primary outcome
Overall survival time
Time frame: From date of randomization until date of death from any cause or last follow up whichever came first, assessed up to 144 months
Change in overall survival in patients receiving extensive diagnostic work up including the standard histology analysis and PDC- based drug screening in addition (interventional arm) compared to patients receiving only standard histology diagnostic work up (standard arm)
3 secondary outcomes
Feasibility of PDC-based drug screening
Time frame: From date of randomization until date of communication of the tumor board outcome, asses up to 144 months
Comparison of Quality of life measurements
Time frame: From date of randomization until date of death from any cause or last follow up whichever came first, assessed up to 144 months
Comparison of neurocognitive function scale
Time frame: From date of randomization until date of death from any cause or last follow up whichever came first, assessed up to 144 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Derived from this study: PubMed 40351832Berghoff AS, Mair MJ, Spiro Z, Abdel Malak C, El-Heliebi A, Eckert F, Furtner J, Konig F, Leibetseder A, Nowosielski M, Oberndorfer S, Prietl B, Pichler J, Pieber TR, Spiegl-Kreinecker S, Urbanic Purkart T, Wohrer A, Widhalm G, Preusser M; ATTRACT study group. Personalized targeted glioblastoma therapies by ex vivo drug screening: Study protocol of the Advanced brain Tumor TheRApy Clinical Trial (ATTRACT). Neurooncol Adv. 2025 Mar 7;7(1):vdaf056. doi: 10.1093/noajnl/vdaf056. eCollection 2025 Jan-Dec.
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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.
AKH Vienna, Department for Internal Medicine I, Oncology
Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBMed Drug Screening Plattform in people with Glioblastoma, 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 7 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 14 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival time (time frame: From date of randomization until date of death from any cause or last follow up whichever came first, assessed up to 144 months). 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 NCT06512311, 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 14 Apr 2026.