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NCT06430736Recrutement en cours

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

Résumé

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.

Critères d'inclusion

• 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

Critères d'exclusion

• 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

Contacts

Les coordonnées de l'équipe de l'essai s'affichent sur demande.

Voir la fiche officielle de l'essai
Statut
Recrutement en cours
Phase
Phase 2
Type d'étude
Interventionnelle
Pays
Suisse
Promoteur
Insel Gruppe AG, University Hospital Bern(Autre)
N° de protocole
PRONTO
Pathologies
Myeloma, Lymphoma, Leukemia
Interventions
Médicament

Traitements évalués

  • Tocilizumab before CAR-T cell infusion
  • Tocilizumab at emerging CRS

Lieux · 1

  • Bern, SuisseInsel Gruppe AGRecrute dans ce centre

Au total, dans le monde, le seul centre listé au registre recrute.

Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 8 juillet 2024).

Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.

Voir aussi

Autres versions

Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.