Personalized Targeted Glioblastoma Therapies by ex Vivo Drug Screening (ATTRACT)

April 9, 2026 updated by: Anna Berghoff, Medical University of Vienna

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

    • 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.

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard group
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.
Experimental: PDC-based drug screening
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.
Diagnostic test: CBMed Drug Screening Plattform
The main devices used within the drug screening process are purchased from PerkinElmer, Liconic Instruments, BioTek and Beckman Coulter Diagnostics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From date of randomization until date of death from any cause or last follow up whichever came first, assessed up to 144 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Number not interpretable results of the PDC-based drug screening; Number of interpretable results of the PDC-based drug screening
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
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.
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
differences in neurocognitive function between the interventional and standard arms using the Neurologic Assessment in Neuro-Oncology (NANO) scale
From date of randomization until date of death from any cause or last follow up whichever came first, assessed up to 144 months

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

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)

July 10, 2024

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATTRACT (Amicus Therapeutics)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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