Comparison between the prophylactic administration of Tocilizumab and administration only as needed in patients receiving CAR-T therapy.
Summary description of the study
You are suffering from a blood, bone marrow, or lymph node disease for which you are being treated with CAR-T therapy. That is why we are asking you if you would like to participate in this study. In CAR-T therapy, cytokine release syndrome (English: Cytokine Release Syndrome, CRS) often occurs as a side effect. Tocilizumab (Actemra®) is routinely used to treat this side effect. In this study, we want to find out how to best treat CRS. So far, the medication has only been used when the side effect occurs (“as needed”). We now want to find out if this side effect can be better treated if the medication is given once preventively (prophylactically). Both strategies have been applied so far, but it is unclear which strategy is more effective. We are investigating in this study whether the strategy of administering Tocilizumab once preventively is better than the current standard, where Tocilizumab is given only after symptoms appear. The medication Tocilizumab is approved for the treatment of CRS in Switzerland. In this study, we are only investigating the best possible timing for the use of Tocilizumab.
(BASEC)
Intervention under investigation
In our study, participants are randomly assigned to two groups. This is important to obtain reliable results from the study. This is called randomization. Each group receives a different treatment:
• Group 1 (experimental group) receives the medication Tocilizumab 1 hour before the administration of the CAR-T infusion (preventively).
• Group 2 (control group) receives the medication Tocilizumab when symptoms appear after the CAR-T infusion (as needed).
(BASEC)
Disease under investigation
Blood, bone marrow, or lymph node disease for which you are being treated with CAR-T therapy
(BASEC)
You are receiving CAR-T treatment at the Inselspital Bern You have confirmed your consent to participate in writing You have been classified by your doctor as clinically suitable for this treatment You are aged ≥18 years (BASEC)
Exclusion criteria
You have already received a Tocilizumab treatment within 3 months prior to the CAR-T infusion You have been treated with an investigational product within 8 weeks prior to the CAR-T infusion. (BASEC)
Trial sites
Bern
(BASEC)
Sponsor
Universitätsklinik für Med. Onkologie, Inselspital, CH-3010 Bern
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Thomas Pabst
+41316328430
thomas.pabst@clutterinsel.chUniversitätsklinik für Med. Onkologie, Inselspital, CH-3010 Bern
(BASEC)
General Information
Insel Gruppe AG Bern Switzerland,
+41 31 632 84 30;0041316328430
thomas.pabst@clutterinsel.ch(ICTRP)
Scientific Information
Insel Gruppe AG Bern Switzerland,
+41 31 632 84 30;0041316328430
thomas.pabst@clutterinsel.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
24.04.2024
(BASEC)
ICTRP Trial ID
NCT06430736 (ICTRP)
Official title (approved by ethics committee)
Prospective comparison between prophylactic and on-demand use of Tocilizumab in CAR-T recipients - a randomized, two arm, open-label, single-center trial (BASEC)
Academic title
Prospective Comparison Between Prophylactic and On-demand Use of Tocilizumab in CAR-T Recipients - a Randomized, Two Arm, Open-label, Single-center Trial (ICTRP)
Public title
PRONTO Trial (PRophylactic Versus ON-demand Use of TOcilizumab) (ICTRP)
Disease under investigation
Myeloma;Lymphoma;Leukemia (ICTRP)
Intervention under investigation
Drug: Tocilizumab before CAR-T cell infusion;Drug: Tocilizumab at emerging CRS (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Patients planned to receive commercial CAR-T treatment for all registered
indications comprising lymphomas, leukemias or myeloma at a single academic center
(Bern Inselspital)
- With written informed consent
- Considered by the investigator to be clinically fit for this treatment
- Patients aged =18 years
Exclusion Criteria:
- Previous Tocilizumab treatment within 3 months prior to CAR-T infusion
- Patients with treatment with an investigational compound within 8 weeks prior to
CAR-T infusion
- Women who are pregnant or breast feeding, or women intending to become pregnant
during the study period; or participants lacking safe contraception, defined as:
Female participants of childbearing potential, not using and not willing to continue
using a medically reliable method of contraception for the entire study duration,
such as oral, injectable, or implantable contraceptives, or intrauterine
contraceptive devices, or who are not using any other method considered sufficiently
reliable by the investigator in individual cases during study treatment and for a
total of 12 months; Female participants who are surgically sterilised /
hysterectomised or post-menopausal for longer than 2 years are not considered as
being of child bearing potential.
- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, etc. of the participant
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees and other dependent
persons (ICTRP)
not available
Primary and secondary end points
Incidence of CRS of all grades (ICTRP)
Incidence of ICANS of all grades;Hospitalization duration;Erythrocyte transfusion needs;Platelet transfusion needs;Incidence of admissions to the intensive care unit;Incidence of infections;Overall survival rates;Progression-free survival rates;IL-6 to monitor CRS;Peripheral molecular CAR-T levels (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Thomas Pabst, Prof.;Thomas Pabst, Prof.;Thomas Pabst, Prof., thomas.pabst@insel.ch, +41 31 632 84 30;0041316328430, Insel Gruppe AG Bern Switzerland, (ICTRP)
Secondary trial IDs
PRONTO (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06430736 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available