Clinical trial · Interventional
Randomized Phase 2 Study to Investigate Efficacy of ALECSAT in Patients With GBM Measured Compared to Avastin/Irinotecan
An Open-labelled, Randomized Phase II Study to Investigate Efficacy of Autologous Lymphoid Effector Cells Specific Against Tumour-Cells (ALECSAT) in Patients With GBM Measured as Progression Free Survival Compared to Avastin/Irinotecan
NCT02060955CI-TRIAL-00022486terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Substantial design modifications required.
Summary
Brief summary (as posted)
The overall purpose of the study is to investigate the efficacy and safety of ALECSAT in patients with relapse of GlioBlastoma Multiforme (GBM) after first line treatments (followed by reoperation if possible). The efficacy and safety of ALECSAT treatment is, compared to standard Bevacizumab/Irinotecan second line treatments for these patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALECSAT | Biological | — | UNRESOLVED |
| Bevacizumab/Irinotecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Alecsat
- description
- The experimental product is an autologous product based on the individual patients blood. Blood donation are performed in study weeks 0, 6, 11, 23 and 43. The patient receives treatment as bolus injection at study weeks 4, 9, 14, 26 and 46.
- interventionNames
- Biological: ALECSAT
- type
- ACTIVE_COMPARATOR
- label
- bevacizumab/irinotecan
- description
- Patients allocated to the comparator arm will be treated in accordance with standard practice in Denmark for relapsed glioblastoma multiforme, up to 16 treatment cycles with 4 weeks duration
- interventionNames
- Drug: Bevacizumab/Irinotecan
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed GBM tumour with recurrence during or after completing the recognized first-line treatments, tumor recurrence, documented by MRI, * Minimum age of 18 years old, * Capable of understanding the information and giving informed consent * Minimum height of 155 cm * Expected survival time (life expectancy) of over 3 months * Adequate performance status equal or below 2 * Clinically normal Erythrocyte Volume Fraction (EVF) * Women in fertile conditions can only be included with a negative pregnancy test at screening and must use appropriate contraceptives during the study Exclusion Criteria: * Positive tests for HIV-1/2; HBsAg, hemoglobin C, hepatitis C virus, or being positive in a Treponema Pallidum test (syphilis) * Patients who may have been exposed to West Nile virus, or Dengue virus or human T-cell lymphotrophic virus (HTLV-1) virus should be excluded, unless the patient has been tested negative * Concurrent illness, e.g. uncontrolled epilepsy, cardiovascular-, cerebrovascular-, and/or respiratory disease which can worsen or cause complications in connection with blood donation * Clinically significant autoimmune disorders or conditions of immune suppression * Hemoglobin count ≤ 7.5mmol/l (men \& women) * Lymphocyte-numbers below 0.5 x 109/l * Body weight below 40 kg (men) and 50 kg (women) * Clinically abnormal ECG as judged by the Investigator * Pregnant or breast feeding women * Inclusion in other clinical studies 4 weeks prior to inclusion in the study * Any medical condition that will render participation in the study risky or, according to the Investigator will make the assessment of the study endpoints difficult * Treatment with any immunotherapy, cytotoxic therapy or, biologic therapy 4 weeks prior to enrolment in this study * Patients that either may be put at risk due to the blood donation or where it is not expected that an ALECSAT product of good quality can be produced, as judged by the Investigator * Patients with uncontrolled serious bacterial, viral, fungal or parasitic infection * Blood transfusions within 48 hours prior to donation of blood for ALECSAT production * Known or suspected intolerance to Avastin, Irinotecan or any of the excipients as well as intolerance to recombinant humanized antibodies Performance status ≥ 3
References
Publications (0)
Data not yet available
No reference posted for this study.