Trials
Search / Trial NCT06430736

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

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · May 21, 2024

Trial Information

Current as of February 18, 2025

Recruiting

Keywords

Tocilizumab Myeloma Leukemia Lymphoma Crs Icans

ClinConnect Summary

The PRONTO Trial is researching how a medication called Tocilizumab can help patients with blood cancers like myeloma, lymphoma, and leukemia. Specifically, the trial is looking at whether giving Tocilizumab before treatment (called prophylactic use) can prevent or lessen serious side effects that sometimes occur after CAR-T therapy, such as a condition known as CRS (cytokine release syndrome) and possible neurotoxicity (effects on the nervous system). The study is currently recruiting participants who are 18 years or older, will be receiving CAR-T treatment, and are considered healthy enough for this therapy.

To participate in the trial, patients cannot have used Tocilizumab in the past three months, and certain health conditions or situations, like pregnancy, may exclude them. Those who join can expect close monitoring and support as researchers gather information on the safety and effectiveness of this treatment approach. It's important to know that this study is taking place at the Bern Inselspital, and participants will need to provide written consent to take part.

Gender

ALL

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

Trial Officials

Thomas Pabst, Prof.

Study Chair

Insel Gruppe AG Bern Switzerland

About Insel Gruppe Ag, University Hospital Bern

Insel Gruppe AG, the umbrella organization for the University Hospital Bern, is a leading healthcare provider in Switzerland, renowned for its commitment to advancing medical research and patient care. As a key player in clinical trials, Insel Gruppe AG integrates cutting-edge scientific inquiry with clinical excellence, facilitating innovative studies that span a wide range of medical disciplines. The institution prioritizes collaboration with academic partners and industry stakeholders to enhance the understanding of diseases and develop effective treatment options, ultimately aiming to improve patient outcomes and contribute to the global medical community.

Locations

Bern, Be, Switzerland

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0