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

NCT02799238 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2020-04-30

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • CytoVac A/S

    lead INDUSTRY

Principal Investigators

  • Katja Werlenius, PhD · Sahlgrenska University Hospital, Gothenburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2019-11-14
Completion
2020-02-24

Countries

  • Sweden

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02799238 on ClinicalTrials.gov