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

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ClinicalTrials.gov Identifier: NCT02799238
Recruitment Status : Active, not recruiting
First Posted : June 14, 2016
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
CytoVac A/S

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).

Condition or disease Intervention/treatment Phase
Glioblastoma Biological: ALECSAT Radiation: radiotherapy Drug: Temozolomide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: open label
Primary Purpose: Treatment
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 Start Date : March 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Radiotherapy in combination with Temozolomide (TMZ)
radiotherapy combined with TMZ treatment followed by adjuvant TMZ
Radiation: radiotherapy
Radiotherapy 5 days/week for 6 weeks

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

Experimental: ALECSAT + Radiotherapy in combination with TMZ
3 doses of ALECSAT /4 weeks followed by ALECSAT every 3 months
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




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: During study period of approximately 46 months ]
    Compare the progression free survival between patients who receive ALECSAT as add on to SoC and patients who only receive SoC


Secondary Outcome Measures :
  1. Proportion of patients alive at 12 and 24 months [ Time Frame: Up to 24 months after enrollment of last patient ]
    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

  2. Frequency and Severity of treatment related Adverse Events [ Time Frame: During study period of approximately 46 months ]
    Comparison of frequency and severity of treatment related AEs in the 2 study groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02799238


Locations
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Sweden
Sahlgrenska University Hospital
Göteborg, Sweden
Ryhov hospital
Jönköping, Sweden, 55185
Skånes university hospital
Lund, Sweden, 221 85
Karolinska University hospital
Stockholm, Sweden, 171 76
Sponsors and Collaborators
CytoVac A/S
Investigators
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Principal Investigator: Katja Werlenius, PhD Sahlgrenska University Hospital, Gothenburg

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Responsible Party: CytoVac A/S
ClinicalTrials.gov Identifier: NCT02799238     History of Changes
Other Study ID Numbers: CV-006
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by CytoVac A/S:
glioblastoma, GBM, immunotherapy, autologous lymphoid effector cells specific against tumour cells, ALECSAT, Stupp regimen, TMZ, radiotherapy/TMZ
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents