BridgeMD
A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients
EU CTIS ID: 2023-504846-73-01
What this study is testing
Compare median overall survival (OS) time in patients with newly-diagnosed glioblastoma and less than 1 cm3 remaining contrast enhancing tumor postoperatively treated with and without valganciclovir as add-on to standard therapy. The primary endpoint is median OS at End of Study (EoS) when the last patient has reached 30 months. OS time is measured from time of resection until death for any reason.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged 18 years or older
- Patients must be enrolled and start their first dose IMP within 10 weeks after surgery
- Patients with newly diagnosed glioblastoma, IDHwt, WHO grade IV
- Patients were a radical tumor resection has been achieved; no more than 1 cm3 remaining contrast enhancing tumor as assessed by postoperative MRI or CT is allowed
- Patients eligible for standard treatment with radiation therapy combined with concomitant and adjuvant temozolomide
- Patients were tumor MGMT promoter methylation status is available
You likely can't join if
- Patients allergic to, or who do not tolerate valganciclovir, aciclovir or valaciclovir
- Abnormal renal function (GFR < 30)
- Secondary glioblastoma or IDH mutated glioblastoma
- Unfit or for any other reason judged ineligible by investigator
- Patients intolerant to ingredients of the study drug tablets
- Patients with decreased cognitive function (below 24 in MMSE test)
See the full eligibility criteria
- Patients aged 18 years or older
- Patients must be enrolled and start their first dose IMP within 10 weeks after surgery
- Patients with newly diagnosed glioblastoma, IDHwt, WHO grade IV
- Patients were a radical tumor resection has been achieved; no more than 1 cm3 remaining contrast enhancing tumor as assessed by postoperative MRI or CT is allowed
- Patients eligible for standard treatment with radiation therapy combined with concomitant and adjuvant temozolomide
- Patients were tumor MGMT promoter methylation status is available
- Patients with KPS >= 70 and ECOG/WHO <= 2
- Patients providing written informed consent
- Patients cooperative and able to complete all study procedures
- Females of child-bearing age must have a negative pregnancy test at screening (all premenopausal women and in women under the age of 55 were menstrual status cannot be ascertained). Female patients must agree to utilize a highly efficient birth control method throughout the study period (Pearl index <1, e.g: oral contraception with gestagens, transdermal contraceptives, implants, injectables, intrauterine devices, bilateral tubal occlusion, sexual abstinence or vasectomised partner). The birth control method must be used until 6 months after last dose of study drug. Pregnancy testing will be performed at monthly intervals due to high teratogenic potential of valganciclovir, and continue for 6 months after the Study drug has been discontinued. Men are recommended to use condoms with female fertile partners during, and for 6 months following treatment with valganciclovir.
- Patients allergic to, or who do not tolerate valganciclovir, aciclovir or valaciclovir
- Abnormal renal function (GFR < 30)
- Secondary glioblastoma or IDH mutated glioblastoma
- Unfit or for any other reason judged ineligible by investigator
- Patients intolerant to ingredients of the study drug tablets
- Patients with decreased cognitive function (below 24 in MMSE test)
- Pregnant or lactating females
- Patients not signing informed consent
- Patients participating in other interventional trials
- Neutrophil count < 1,5 cells/ 109/L
- Platelet count < 150 cells/ 109/L
- HGB < 80 g/L
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.