PRONTO Trial (PRophylactic Versus ON-demand Use of TOcilizumab)

Recruiting now · Phase 2

Conditions studied: Myeloma, Lymphoma, Leukemia

In brief

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.

Key facts

Study ID

NCT06430736

Run by

Insel Gruppe AG, University Hospital Bern

People needed

100

Starts

2024-07-01

Expected to finish

2027-06-01

Last updated by the study team

2024-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Insel Gruppe AG — Bern, Canton of Bern, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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