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

NCT07593482 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-05-18

No results posted yet for this study

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).

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.

Sponsors & Collaborators

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • Benjamin Kasenda, PD Dr. med. Dr. phil. · University Hospital Basel (USB)

  • Guido Ghilardi · Ente Ospedaliero Cantonale (EOC)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-03-31
Completion
2030-03-31

Countries

  • Switzerland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07593482 on ClinicalTrials.gov