NCT07593482Recrutement en cours
Bendamustine Versus Fludarabine/Cyclophosphamide for Lymphodepletion in Chimeric Antigen Receptor T-cell Immunotherapy (CAR-T): a Randomized Trial.
Résumé
Bendamustine and the combination of fludarabine/cyclophosphamide are fully authorized chemotherapy agents in Switzerland for lymphoma treatment and currently used in routine clinical practice as lymphodepletion strategy before CAR-T immunotherapy, as supported by retrospective studies and clinical experience across multiple centers. None of the drugs described in this protocol are being used at unapproved doses, or in an investigational formulation. Both lymphodepletion regimens have a known safety profile and the risks and burdens imposed on participants do not exceed those encountered in routine CAR-T therapy management, as all procedures (including monitoring, supportive care, and follow-up assessments) align with standard clinical practice. Based on these assumptions, this protocol is designed to investigate the use of bendamustine as an alternative lymphodepletion therapy (which is a part of CAR-T immunotherapy protocol).
Critères d'inclusion
• Diagnosis of large B-cell lymphoma (LBCL) with at least one line of previous treatment and indication for commercial CAR-T cell therapy as determined by the treating physician. This includes: Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS) and all specific DLBCL subtypes, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma, and other transformed indolent B-cell lymphomas (including transformed marginal zone lymphoma and Richter's transformation). Patients with primary or secondary central nervous system (CNS) involvement are eligible. • Planned treatment with commercially available CAR-T cell product • Age ≥18 years • Ability to provide written informed consent
Critères d'exclusion
• Administration of any other experimental drug within 5 half-lives or ≤ 4 weeks prior to lymphodepletion therapy starts. • Bendamustine 3 months before leukapheresis. After leukapheresis, bendamustine use is allowed as bridging therapy according to physician decision. • Previous administration of anti-CD19 CAR-T products within the last 12 months from lymphodepletion therapy start. • Known history of hypersensitivity to the active substance or any of the excipients found in the composition of bendamustine, fludarabine, or cyclophosphamide.
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
- Swiss Cancer Institute(Autre)
- N° de protocole
- SCI-003_FC-BALANCE
- Pathologies
- B-cell Lymphoma
- Interventions
- Médicament
Traitements évalués
- bendamustine hydrochloride
- Cyclophosphamide
- Fludarabine
Lieux · 8
- Aarau, SuisseKantonsspital AarauRecrute dans ce centre
- Basel, SuisseUniversitätsspital BaselRecrute dans ce centre
- Bellinzona, SuisseEnte Ospedaliero Cantonale (EOC)-Istituto Oncologico della Svizzera Italiana (IOSI)Recrute dans ce centre
- Chur, SuisseKantonsspital GraubündenRecrute dans ce centre
- Geneva, SuisseLes hôpitaux universitaires de GenèveRecrute dans ce centre
- Lucerne, SuisseLuzerner KantonsspitalRecrute dans ce centre
- Sankt Gallen, SuisseHOCH Health Ostschweiz - Kantonsspital St. GallenRecrute dans ce centre
- Zurich, SuisseKlinik für Hämatologie und Onkologie Hirslanden ZürichRecrute dans ce centre
Au total, dans le monde, 8 des 9 centres listés au registre recrutent ; l'autre ne recrute pas actuellement.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 27 octobre 2026).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
Autres identifiants
- 2026-525792-36-00 · n° CTIS
- U1111-1335-8513 · autre identifiant
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.