NCT02799238

Autologuos Lymphoid Effector Cells Specific Against Tumour (ALECSAT) as Add on to Standard of Care in Patients With Glioblastoma

An Open Label, Randomised, Phase II Study to Investigate the Efficacy and Safety of ALECSAT Treatment as an add-on Therapy to Radiotherapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: CytoVac A/S · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a randomised, open-label, multi-centre, Phase II study in patients with newly diagnosed glioblastoma. 62 patients with newly diagnosed glioblastoma are enrolled in the study in a 1:2 allocation (standard of care (SOC): ALECSAT as an adjunct therapy to SOC). Patients recruited into this study will receive either: * ALECSAT as an adjunct therapy to standard of care for newly diagnosed glioblastoma (first line therapy: Stupp regimen, followed by second line therapy at the Investigator's discretion) or * Standard of care therapy for newly diagnosed glioblastoma (first line therapy: Stupp regimen, followed by second line therapy at the Investigator's discretion).

Conditions

• Glioblastoma

Interventions

Type	Name	Description
BIOLOGICAL	ALECSAT	3 doses of ALECSAT/4 weeks followed by ALECSAT/3 months
RADIATION	Radiotherapy	Radiotherapy 5 days/week for 6 weeks
DRUG	Temozolomide	Temozolomide daily for 6 weeks followed by 6 cycles 5days/4weeks

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-11-14
• Completion: 2020-02-24
• First posted: 2016-06-14
• Last updated: 2020-04-30

Locations

4 sites across 1 country: Sweden