Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT01588769
Eligibility Criteria:
Inclusion Criteria:
1. Recurrence of GBM tumour documented by MRI and PET in patients having received all available standard treatment.
2. Be over the age of 18 and capable of understanding the information and giving informed consent.
3. Adequate performance status \> 50% (see below\*).
* Performance is monitored according to the Karnofsky Performance Score (KPS)
* 100% - normal, no complaints, no signs of disease
* 90% - capable of normal activity, few symptoms or signs of disease
* 80% - normal activity with some difficulty, some symptoms or signs
* 70% - caring for self, not capable of normal activity or work
* 60% - requiring some help, can take care of most personal requirements
* 50% - requires help often, requires frequent medical care
* 40% - disabled, requires special care and help
* 30% - severely disabled, hospital admission indicated but no risk of death
* 20% - very ill, urgently requiring admission, requires supportive measures or treatment
* 10% - moribund, rapidly progressive fatal disease processes
* 0% - death.
Exclusion Criteria:
1. A low blood count (haemoglobin \< 6.0 mmol/l).
2. Lymphocyte counts below 0.8 x 109/l.
3. Positive tests for anti-HIV-1/2;
4. Positive tests for HBsAg,
5. Positive tests for anti-HBc and Anti-HCV.
6. Syphilis i.e. being positive in a Treponema Pallidum test.
7. Uncontrolled serious bacterial, viral, fungal or parasitic infection.
8. Clinically significant autoimmune disorders or conditions of immune suppression.
9. Treatment with chemotherapy three weeks prior to inclusion in the clinical trial.
10. Pregnant women cannot be included in the trial. Fertile women can only be included with a negative pregnancy test and must use contraceptives during the study.
11. Blood transfusions within 48 hours prior to donation of blood for ALECSAT production.
12. Inclusion in other clinical trials 6 weeks prior to inclusion in the trial.
13. The patient's medical condition is evaluated to be so poor that there is a significant risk for the patient to be part of the trial and to evaluate any effects of the treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01588769
Study Brief:
Protocol Section:
NCT01588769