Glioblastoma multiforme MedDRA version: 20.0 Level: PT Classification code 10018337 Term: Glioblastoma multiforme System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: ALECSAT
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: No INN has been allocated to ALECSAT
Other descriptive name: AUTOLOGOUS T-LYMPHOCYTES
Concentration unit: Other
Sponsors
CytoVac A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients, aged between 18 and 70. 2. Histologically confirmed, newly diagnosed glioblastoma, including gliosarcoma. 3. Eligible for combined radiotherapy and TMZ treatment. (Stupp treatment) 4. Patients with complete or partial tumour resection. For patients with limited tumour volume, biopsy is acceptable. 5. WHO Performance status 0-2. 6. Body weight 40 = kg (males), 50 = kg (females). 7. Able and willing to provide written informed consent and comply with the study protocol and procedures. 8. Women of child-bearing potential must have a negative pregnancy test at screening and agree to use acceptable methods of contraception during the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral, intravaginal and transdermal contraceptives, some intrauterine devices (IUDs), intrauterine system (IUS), bilateral tubal occlusion, sexual abstinence or vasectomised partner. True abstinence should be consistent with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post- ovulation methods) and withdrawal are not acceptable methods of contraception. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Prior treatment for brain tumours at study entry. 2. Prior treatment with temozolomide at study entry. 3. Females who are pregnant, planning to become pregnant or breastfeeding. 4. Positive tests for anti- human immunodeficiency virus (HIV)-1/2; HBsAg, anti HBc, anti-HCV or being positive in a Treponema Pallidum test (syphilis). 5. Patients who may have been exposed to high risk contagious virus within a reasonable time prior to enrolment should be excluded, unless the patient has been tested negative. e.g. by travelling in areas of the world with known high risk of infection or known epidemics, (in particular but not limited to West Nile virus (in season), Dengue fever, Zika or Ebola when outbreaks are recognized) 6. 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. 7. Known allergy to study medication. 8. Any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the safety of the investigational drug. 9. Any concurrent illness that may worsen or cause complications in connection with blood donation, for example uncontrolled epilepsy, cardiovascular, cerebrovascular or respiratory disease. 10. Use of immunosuppressant drugs with the exception of steroids. 11. Blood transfusion within 48 hours prior to the donation of blood for ALECSAT production. 12. Low haemoglobin count, in the opinion of the Investigator. 13. Lymphocyte count <0.3 x 10E9 /litre. 14. Receiving any other experimental treatment, including compassionate use programs and other interventional clinical studies for glioblastoma, within 30 days prior to inclusion, at the moment of inclusion or during active treatment within the assigned group. 15. TMZ contraindication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To obtain preliminary but not conclusive evidence by analysing PFS in patients receiving ALECSAT as add-on therapy to radiotherapy and TMZ (SOC) versus patients receiving SOC only.;Secondary Objective: a) To compare OS between patients who received ALECSAT as an add- on therapy to SOC versus patients who received SOC only. b) To compare OS rate at 12 and 24 months between patients who received ALECSAT as an add-on therapy to SOC versus patients who received SOC only. c) To assess the safety of ALECSAT treatment.;Primary end point(s): PFS is measured as the time from surgical resection to the date of investigator assessed progressive disease (PD) or death by any cause. PD will be declared based on MRI scans, clinical status, and corticosteroid usage according to the Revised Assessment for Neuro-Oncology (RANO) criteria.;Timepoint(s) of evaluation of this end point: The final analysis will be carried out when 47 events (investigator assessed progression or death by any cause) have been observed. Twenty-four months after recruitment to the study has closed, treatment and data collection for any patients still alive will end and the study will close. Any data collected for patients still alive after the point of final analysis (47 events) until study closure (24 months after recruitment has closed) will be analysed and included as an addendum to the final report. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy a) OS time is measured from time of surgical resection until death for any reason. b) Proportion of patients alive at 12 and 24 months after randomization (1-year and 2-year OS). Safety Endpoints: • Adverse events and pregnancies • Safety laboratory parameters • Immune system status Exploratory Endpoint: • PFS measured as the time from surgical resection to the date of PD centrally assessed ;Timepoint(s) of evaluation of this end point: Efficacy a) OS time is measured from time of surgical resection until death for any reason. b) Proportion of patients alive at 12 and 24 months after randomization (1-year and 2-year OS). Safety Endpoints: • Adverse events and pregnancies • Safety laboratory parameters • Immune system status Exploratory Endpoint: • PFS measured as the time from surgical resection to the date of PD centrally assessed | — |
Countries
Sweden
Contacts
Public ContactClinical Trials Information
CytoVac A/S
Outcome results
None listed