GlioblastomaPhase 2ALECSATNCT02799238
Autologuos Lymphoid Effector Cells Specific Against Tumour (ALECSAT) as Add on to Standard of Care in Patients With Glioblastoma
A Phase 2 study testing ALECSAT, Radiotherapy and Temozolomide in people with Glioblastoma, run by CytoVac A/S at 4 sites in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- ALECSAT, Radiotherapy and Temozolomide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 4 sitesSweden
- Study dates
- Mar 2016to 24 Feb 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Sahlgrenska University Hospital
Gothenburg
Ryhov hospital
Jönköping, 55185
Skånes university hospital
Lund, 221 85
Karolinska University hospital
Stockholm, 171 76
About this study
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
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
- Being tested
- ALECSAT, Radiotherapy, Temozolomide
- Keywords
- glioblastoma, GBM, immunotherapy, autologous lymphoid effector cells specific against tumour cells, ALECSAT, Stupp regimen, TMZ, radiotherapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALECSATBiological
3 doses of ALECSAT/4 weeks followed by ALECSAT/3 months
RadiotherapyRadiation
Radiotherapy 5 days/week for 6 weeks
TemozolomideDrug
Temozolomide daily for 6 weeks followed by 6 cycles 5days/4weeks
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy in combination with Temozolomide (TMZ) | Active comparator | radiotherapy combined with TMZ treatment followed by adjuvant TMZ Receives: Radiation: Radiotherapy; Drug: Temozolomide |
| ALECSAT + Radiotherapy in combination with TMZ | Experimental | 3 doses of ALECSAT /4 weeks followed by ALECSAT every 3 months Receives: Biological: ALECSAT; Radiation: Radiotherapy; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Compare the progression free survival between patients who receive ALECSAT as add on to SoC and patients who only receive SoC
Measured: 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
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
Measured: 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
Comparison of frequency and severity of treatment related AEs in the 2 study groups
Measured: Up to 24 months after randomisation of last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startMar 2016
- Primary completion14 Nov 2019
- Study completion24 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytoVac A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katja Werlenius, PhD, Principal investigator, Sahlgrenska University Hospital, Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799238
- Sponsor's protocol ID
- CV-006
- Acronym
- ALECSAT
- Status last verified
- Apr 2020
- First submitted
- 6 Jun 2016
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02799238
- Acronym / sponsor ID
- ALECSAT / CV-006
- Conditions
- Glioblastoma
- Keywords
- glioblastoma, GBM, immunotherapy, autologous lymphoid effector cells specific against tumour cells, ALECSAT, Stupp regimen, TMZ, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- CytoVac A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy in combination with Temozolomide (TMZ) | Active comparator | Radiation: Radiotherapy, Drug: Temozolomideradiotherapy combined with TMZ treatment followed by adjuvant TMZ |
| ALECSAT + Radiotherapy in combination with TMZ | Experimental | Biological: ALECSAT, Radiation: Radiotherapy, Drug: Temozolomide3 doses of ALECSAT /4 weeks followed by ALECSAT every 3 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALECSAT3 doses of ALECSAT/4 weeks followed by ALECSAT/3 months | Biological | ALECSAT + Radiotherapy in combination with TMZ |
| RadiotherapyRadiotherapy 5 days/week for 6 weeks | Radiation | ALECSAT + Radiotherapy in combination with TMZ, Radiotherapy in combination with Temozolomide (TMZ) |
| TemozolomideTemozolomide daily for 6 weeks followed by 6 cycles 5days/4weeks | Drug | ALECSAT + Radiotherapy in combination with TMZ, Radiotherapy in combination with Temozolomide (TMZ) |
Primary outcome
Progression Free Survival
Time frame: 24 months after LPFV or when 47 patients has reached investigator assessed disease progression or death from any cause
Compare the progression free survival between patients who receive ALECSAT as add on to SoC and patients who only receive SoC
2 secondary outcomes
Proportion of patients alive at 12 and 24 months
Time frame: 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
Time frame: Up to 24 months after randomisation of last patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katja Werlenius, PhD principal investigator
Sahlgrenska University Hospital, Gothenburg
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALECSAT, Radiotherapy and Temozolomide in people with Glioblastoma, run by CytoVac A/S at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 24 months after LPFV or when 47 patients has reached investigator assessed disease progression or death from any cause). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.