NCT02060955

Randomized Phase 2 Study to Investigate Efficacy of ALECSAT in Patients With GBM Measured Compared to Avastin/Irinotecan

An Open-labelled, Randomized Phase II Study to Investigate Efficacy of Autologous Lymphoid Effector Cells Specific Against Tumour-Cells (ALECSAT) in Patients With GBM Measured as Progression Free Survival Compared to Avastin/Irinotecan

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: CytoVac A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall purpose of the study is to investigate the efficacy and safety of ALECSAT in patients with relapse of GlioBlastoma Multiforme (GBM) after first line treatments (followed by reoperation if possible). The efficacy and safety of ALECSAT treatment is, compared to standard Bevacizumab/Irinotecan second line treatments for these patients.

Detailed description

This study is an open-label, randomized, prospective, parallel group phase II study with ALECSAT compared to Bevacizumab/Irinotecan in patients with verified relapsed glioblastoma multiforme after or during treatment with recognised first-line treatment. After 62 PFS events have been recorded, an interim analysis will be conducted under the auspices of the Data Monitoring Committee. The patients in the two treatment groups will be followed for up to 62 weeks by planned study visits. Patients with, at least, stable disease will continue the allocated treatment after the study period as judged by the Investigator. Patients allocated to the Bevacizumab/Irinotecan (control group) will receive their treatment according to standard praxis, i.e. up to 16 treatment cycles with 4 weeks duration. Each cycle of Bevacizumab/Irinotecan consist of 2 dosing days; day 1 and day 15 in the cycle.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
BIOLOGICAL	ALECSAT	The ALECSAT will be administered at week 4, 9, 14, 26 and week 46. Cells are re-suspended in a plasmalyte injection fluid up to a total volume of 20 ml. The 20 ml cell suspension will contain between 10 million and 1 billion cells. Each dose is supplied in a sterile 20 ml syringe and should be injected intravenously.
DRUG	Bevacizumab/Irinotecan	Patients allocated to the Bevacizumab/Irinotecan (control group) will receive treatment according to standard praxis, i.e. up to 16 treatment cycles with 4 weeks duration. Each cycle consist of 2 dosing days; day 1 and day 15 in the cycle.

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-06-01
• Completion: 2015-07-01
• First posted: 2014-02-12
• Last updated: 2016-06-06

Locations

4 sites across 1 country: Denmark