Clinical Trial

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

Study acronym: FC-BALANCE
Not Yet Recruiting Phase 2
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).
Trial Details
NCT Number NCT07593482
Lead Sponsor Swiss Cancer Institute
Conditions B-cell Lymphoma
Enrollment 92 participants
Start Date 2026-09
Primary Completion 2029-03 (estimated)
Study Completion 2030-03 (estimated)
Updated on ClinicalTrials.gov 2026-05-18