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

NCT02799238 | Completed Phase 2 DMC

• 1 other identifier: CV-006
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

glioblastoma, GBM, immunotherapy, autologous lymphoid effector cells specific against tumour cells, ALECSAT, Stupp regimen, TMZ, radiotherapy

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

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

  24 months after LPFV or when 47 patients has reached investigator assessed disease progression or death from any cause

Secondary Outcomes (2)

• Proportion of patients alive at 12 and 24 months

  24 months after LPFV or when 47 patients has reached investigator assessed disease progression or death from any cause

• Frequency and Severity of treatment related Adverse Events

  Up to 24 months after randomisation of last patient

Study Arms (2)

Radiotherapy in combination with Temozolomide (TMZ)

ACTIVE COMPARATOR

radiotherapy combined with TMZ treatment followed by adjuvant TMZ

Radiation: Radiotherapy; Drug: Temozolomide

ALECSAT + Radiotherapy in combination with TMZ

EXPERIMENTAL

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

Biological: ALECSAT; Radiation: Radiotherapy; Drug: Temozolomide

Interventions

ALECSAT BIOLOGICAL

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

ALECSAT + Radiotherapy in combination with TMZ

Radiotherapy RADIATION

Radiotherapy 5 days/week for 6 weeks

ALECSAT + Radiotherapy in combination with TMZ; Radiotherapy in combination with Temozolomide (TMZ)

Temozolomide DRUG

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

ALECSAT + Radiotherapy in combination with TMZ; Radiotherapy in combination with Temozolomide (TMZ)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients, aged between 18 and 70.
• Histologically confirmed glioblastoma (Grade IV) diagnosis.
• Eligible for combined radiotherapy and TMZ treatment.
• Patients with complete or partial tumour resection. For patients with limited tumour volume, biopsy is acceptable.
• WHO Performance status 0-2.
• Body weight ≥ 40 kg (males), ≥ 50 kg (females).
• Able and willing to provide written informed consent and comply with the study protocol and procedures.
• Women of child-bearing potential must have a negative pregnancy test at screening and agree to use acceptable methods of contraception during the trial.

You may not qualify if:

• Prior treatment for brain tumours at study entry.
• Prior treatment with temozolomide at study entry.
• Females who are pregnant, planning to become pregnant or breastfeeding.
• Positive tests for anti- human immunodeficiency virus (HIV)-1/2; HBsAg, anti HBc, anti-HCV or being positive in a Treponema Pallidum test (syphilis).
• Patients who may have been exposed to West Nile virus or Dengue fever virus within the last 28 days prior to enrolment or Ebola virus within the last 60 days prior to enrolment should be excluded, unless the patient has been tested negative.
• Patients from high incidence areas for Human T-Lymphotropic Virus (HTLV-1) virus or who has a parent or spouse from a high incidence area must be excluded unless tested negative for HTLV-1 virus.
• Known allergy to study medication.
• Any condition or illness that, in the opinion of the Investigator or medical monitor, would compromise patient safety or interfere with the evaluation of the safety of the investigational drug.
• Any concurrent illness that may worsen or cause complications in connection with blood donation, for example uncontrolled epilepsy, cardiovascular, cerebrovascular or respiratory disease.
• Use of immunosuppressant drugs with the exception of steroids. Blood transfusion within 48 hours prior to the donation of blood for ALECSAT production.
• Low haemoglobin count in the opinion of the Investigator.
• Lymphocyte count \<0.3 x 109/litre.
• TMZ contraindication.

Sponsors & Collaborators

• CytoVac A/S: lead

Study Sites (4)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Ryhov hospital

Jönköping, 55185, Sweden

Location

Skånes university hospital

Lund, 221 85, Sweden

Location

Karolinska University hospital

Stockholm, 171 76, Sweden

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Radiotherapy; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Katja Werlenius, PhD

  Sahlgrenska University Hospital, Gothenburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 14, 2016
• Study Start: March 1, 2016
• Primary Completion: November 14, 2019
• Study Completion: February 24, 2020
• Last Updated: April 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)