NCT06430736 PRONTO Trial (PRophylactic Versus ON-demand Use of TOcilizumab)
| NCT ID | NCT06430736 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-07-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Despite the consequent use of Tocilizumab together with conventional antipyretics at early/first signs of emerging CRS, CRS (and eventually the subsequent development of ICANS) remain a major concern for patients. This study aims to identify safety and efficacy of prophylactic Tocilizumab treatment. In particular, to explore whether prophylactic Tocilizumab treatment can decrease the incidence and severity of CRS (and subsequent eventual neurotoxicity) following CAR-T-treatment.
Eligibility Criteria
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
Contact & Investigator
Thomas Pabst, Prof.
STUDY CHAIR
Insel Gruppe AG Bern Switzerland
Frequently Asked Questions
Who can join the NCT06430736 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06430736 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06430736 currently recruiting?
Yes, NCT06430736 is actively recruiting participants. Contact the research team at thomas.pabst@insel.ch for enrollment information.
Where is the NCT06430736 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT06430736 clinical trial?
NCT06430736 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Thomas Pabst, Prof. at Insel Gruppe AG Bern Switzerland. The trial plans to enroll 100 participants.