Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Temozolomide

Immunomodulating Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

radiotherapy combined with TMZ treatment followed by adjuvant TMZ

3 doses of ALECSAT /4 weeks followed by ALECSAT every 3 months

3 doses of ALECSAT/4 weeks followed by ALECSAT/3 months

ALECSAT

Radiotherapy

Temozolomide daily for 6 weeks followed by 6 cycles 5days/4weeks

Katja Werlenius, PhD

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).

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

Compare the progression free survival between patients who receive ALECSAT as add on to SoC and patients who only receive SoC

To compare OS rate at 12 and 24 months between patients who receive ALECSAT as add on to SoC and patients who only receive SoC

Comparison of frequency and severity of treatment related AEs in the 2 study groups

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Autologuos Lymphoid Effector Cells Specific Against Tumour (ALECSAT) as Add on to Standard of Care in Patients With Glioblastoma	NCT02799238	Glioblastoma	ALECSAT Radiotherapy Temozolomide	18 Years - 70 Years	CytoVac A/S
Autologuos Lymphoid Effector Cells Specific Against Tumour (ALECSAT) as Add on to Standard of Care in Patients With Glioblastoma	NCT02799238	Glioblastoma	ALECSAT Radiotherapy Temozolomide	18 Years - 70 Years	CytoVac A/S
Autologuos Lymphoid Effector Cells Specific Against Tumour (ALECSAT) as Add on to Standard of Care in Patients With Glioblastoma	NCT02799238	Glioblastoma	ALECSAT Radiotherapy Temozolomide	18 Years - 70 Years	CytoVac A/S

Spots Global Cancer Trial Database for glioblastoma, gbm, immunotherapy, autologous lymphoid effector cells specific against tumour cells, alecsat, stupp regimen, tmz, radiotherapy