Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 6, 2016
First Posted Date  ICMJE June 14, 2016
Last Update Posted Date February 26, 2019
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2016)
Overall Survival [ Time Frame: During study period of approximately 46 months ]
compare overall survival between patients who receive ALECSAT as add on to SoC and patients who only receive SoC
Change History Complete list of historical versions of study NCT02799238 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2019)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2016)
  • Proportion of patients alive at 12, 24 and 36 months [ Time Frame: Up to 36 months after enrollment of first patient ]
    To compare OS rate at 12, 24 and 36 months between patients who receive ALECSAT as add on to SoC and patients who only receive SoC
  • Progression Free Survival [ Time Frame: During study period of approximately 46 months ]
    To compare the progression free survival
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologuos Lymphoid Effector Cells Specific Against Tumour (ALECSAT) as Add on to Standard of Care in Patients With Glioblastoma
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
open label
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Radiotherapy in combination with Temozolomide (TMZ)
    radiotherapy combined with TMZ treatment followed by adjuvant TMZ
    Interventions:
    • Radiation: radiotherapy
    • Drug: Temozolomide
  • Experimental: ALECSAT + Radiotherapy in combination with TMZ
    3 doses of ALECSAT /4 weeks followed by ALECSAT every 3 months
    Interventions:
    • Biological: ALECSAT
    • Radiation: radiotherapy
    • Drug: Temozolomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 25, 2019)
62
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2016)
87
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02799238
Other Study ID Numbers  ICMJE CV-006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party CytoVac A/S
Study Sponsor  ICMJE CytoVac A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Katja Werlenius, PhD Sahlgrenska University Hospital, Gothenburg
PRS Account CytoVac A/S
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP