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RECRUITING
NCT07593482
PHASE2

Bendamustine Versus Fludarabine/Cyclophosphamide for Lymphodepletion in Chimeric Antigen Receptor T-cell Immunotherapy (CAR-T): a Randomized Trial.

Sponsor: Swiss Cancer Institute

View on ClinicalTrials.gov

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

DRUG

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)

DRUG

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.

DRUG

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