VALGANCICLOVIR for Glioblastoma multiforme (WHO grade IV)

Inclusion criteria

• {"criterion_text":"- Patients aged 18 years or older\n- Patients must be enrolled and start their first dose IMP within 10 weeks after surgery\n- Patients with newly diagnosed glioblastoma, IDHwt, WHO grade IV\n- 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\n- Patients eligible for standard treatment with radiation therapy combined with concomitant and adjuvant temozolomide\n- Patients were tumor MGMT promoter methylation status is available\n- Patients with KPS >= 70 and ECOG/WHO <= 2\n- Patients providing written informed consent\n- Patients cooperative and able to complete all study procedures\n- 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."}

Exclusion criteria

• {"criterion_text":"- Patients allergic to, or who do not tolerate valganciclovir, aciclovir or valaciclovir\n- Abnormal renal function (GFR < 30)\n- Secondary glioblastoma or IDH mutated glioblastoma\n- Unfit or for any other reason judged ineligible by investigator\n- Patients intolerant to ingredients of the study drug tablets\n- Patients with decreased cognitive function (below 24 in MMSE test)\n- Pregnant or lactating females\n- Patients not signing informed consent\n- Patients participating in other interventional trials\n- Neutrophil count < 1,5 cells/ 109/L\n- Platelet count < 150 cells/ 109/L\n- HGB < 80 g/L"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"OS time is measured from time of resection until death for any reason; primary endpoint is median overall survival at End of Study when last patient has reached 30 months."}

Secondary endpoints

• {"endpoint_text":"- Compare different survival and toxicity parameters in patients with newly-diagnosed glioblastoma treated with and without valganciclovir as add-on to standard therapy.","definition_or_measurement_approach":"Includes one- and two-year (12 and 24 months) survival rates; median progression free survival (PFS) time measured from resection to objective demonstration of disease progression or death; quality of life assessments by EORTC QLQ C30 and BN20 at baseline and at 3, 6, 9, 12, 15, 18, 21, 24 and 30 months; proportion with progressive or stable disease at 12 and 24 months; subgroup analyses by CMV status, Optune treatment, and surgical interventions; evaluation of safety and tolerance for valganciclovir as add-on."}

Sweden

Earliest CTIS Part Ii Submission Date

17-10-2024

Latest Decision Or Authorization Date

29-10-2024

Processing Time Days

12

Number Of Sites

1

Number Of Participants

190

Norway

Earliest CTIS Part Ii Submission Date

17-10-2024

Latest Decision Or Authorization Date

29-10-2024

Processing Time Days

12

Number Of Sites

2

Number Of Participants

30

Primary sponsor

Full Name

Karolinska Institutet

Organisation Type

Educational Institution

Country Of Registered Address

Sweden