Back to resultsAutologuos Lymphoid Effector Cells Specific Against Tumour (ALECSAT) as Add on to Standard of Care in Patients With Glioblastoma (ALECSAT)
Primary Purpose
Glioblastoma
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
ALECSAT
Radiotherapy
Temozolomide
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma focused on measuring glioblastoma, GBM, immunotherapy, autologous lymphoid effector cells specific against tumour cells, ALECSAT, Stupp regimen, TMZ, radiotherapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Participation in any other interventional clinical trial within 30 days prior to inclusion.
- TMZ contraindication.
Sites / Locations
- Sahlgrenska University Hospital
- Ryhov hospital
- Skånes university hospital
- Karolinska University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Radiotherapy in combination with Temozolomide (TMZ)
ALECSAT + Radiotherapy in combination with TMZ
Arm Description
radiotherapy combined with TMZ treatment followed by adjuvant TMZ
3 doses of ALECSAT /4 weeks followed by ALECSAT every 3 months
Outcomes
Primary Outcome Measures
Progression Free Survival
Compare the progression free survival between patients who receive ALECSAT as add on to SoC and patients who only receive SoC
Secondary Outcome Measures
Proportion of patients alive at 12 and 24 months
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
Frequency and Severity of treatment related Adverse Events
Comparison of frequency and severity of treatment related AEs in the 2 study groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02799238
Brief Title
Autologuos Lymphoid Effector Cells Specific Against Tumour (ALECSAT) as Add on to Standard of Care in Patients With Glioblastoma
Acronym
ALECSAT
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
November 14, 2019 (Actual)
Study Completion Date
February 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CytoVac A/S
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
glioblastoma, GBM, immunotherapy, autologous lymphoid effector cells specific against tumour cells, ALECSAT, Stupp regimen, TMZ, radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
open label
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiotherapy in combination with Temozolomide (TMZ)
Arm Type
Active Comparator
Arm Description
radiotherapy combined with TMZ treatment followed by adjuvant TMZ
Arm Title
ALECSAT + Radiotherapy in combination with TMZ
Arm Type
Experimental
Arm Description
3 doses of ALECSAT /4 weeks followed by ALECSAT every 3 months
Intervention Type
Biological
Intervention Name(s)
ALECSAT
Intervention Description
3 doses of ALECSAT/4 weeks followed by ALECSAT/3 months
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Radiotherapy 5 days/week for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
Temozolomide daily for 6 weeks followed by 6 cycles 5days/4weeks
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
Compare the progression free survival between patients who receive ALECSAT as add on to SoC and patients who only receive SoC
Time Frame
24 months after LPFV or when 47 patients has reached investigator assessed disease progression or death from any cause
Secondary Outcome Measure Information:
Title
Proportion of patients alive at 12 and 24 months
Description
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
Time Frame
24 months after LPFV or when 47 patients has reached investigator assessed disease progression or death from any cause
Title
Frequency and Severity of treatment related Adverse Events
Description
Comparison of frequency and severity of treatment related AEs in the 2 study groups
Time Frame
Up to 24 months after randomisation of last patient
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Participation in any other interventional clinical trial within 30 days prior to inclusion.
TMZ contraindication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katja Werlenius, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Gothenburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Göteborg
Country
Sweden
Facility Name
Ryhov hospital
City
Jönköping
ZIP/Postal Code
55185
Country
Sweden
Facility Name
Skånes university hospital
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Karolinska University hospital
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
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Autologuos Lymphoid Effector Cells Specific Against Tumour (ALECSAT) as Add on to Standard of Care in Patients With Glioblastoma
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