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Bendamustine Versus Fludarabine/Cyclophosphamide for Lymphodepletion in Chimeric Antigen Receptor T-cell Immunotherapy (CAR-T): a Randomized Trial.
Sponsor: Swiss Cancer Institute
Summary
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).
Official title: Bendamustine Versus Fludarabine/Cyclophosphamide for Lymphodepletion in CAR-T Therapy: a Randomized Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
92
Start Date
2026-09-14
Completion Date
2030-03
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
bendamustine hydrochloride
* Dose: 90 mg/m² body surface area * Route: Intravenous infusion * Administration: Infused over 30-60 minutes in 500 mL normal saline or 5% dextrose * Pre-medication: Standard institutional protocols for bendamustine administration (typically antiemetics)
Cyclophosphamide
* Administration: Intravenous infusion per institutional protocols and product guidelines. * Dose: according to the specification described in the prescription information sheet of the CAR-T product used.
Fludarabine
* Administration: Intravenous infusion per institutional protocols and product guidelines. * Dose: according to the specification described in the prescription information sheet of the CAR-T product used.
Locations (9)
Kantonsspital Aarau
Aarau, Switzerland
Universitätsspital Basel
Basel, Switzerland
Ente Ospedaliero Cantonale (EOC)-Istituto Oncologico della Svizzera Italiana (IOSI)
Bellinzona, Switzerland
Inselspital Bern - Universitätsklinik für Medizinische Onkologie
Bern, Switzerland
Kantonsspital Graubünden
Chur, Switzerland
Les hôpitaux universitaires de Genève
Geneva, Switzerland
Luzerner Kantonsspital
Lucerne, Switzerland
HOCH Health Ostschweiz - Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Klinik für Hämatologie und Onkologie Hirslanden Zürich
Zurich, Switzerland