Bendamustine vs standard lymphodepletion before CAR-T in LBCL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 randomized trial compares bendamustine alone to the standard flu/cyclophosphamide lymphodepletion regimen prior to CAR-T cell therapy in adults with relapsed/refractory large B-cell lymphoma. All regimens are given as part of routine practice, with safety monitoring and follow-up aligned to standard CAR-T care. The study aims to determine whether bendamustine can support CAR-T cell expansion and efficacy similarly to or better than the current standard. Outcomes focus on safety, treatment-related toxicities, and early signals of effectiveness in the context of approved CAR-T products. Eligible participants have LBCL after at least one prior treatment and are planned to receive a commercially available CAR-T product.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Where it's running

• Kantonsspital Aarau
  Aarau, Switzerland Recruiting
• Universitätsspital Basel
  Basel, Switzerland Recruiting
• Ente Ospedaliero Cantonale (EOC)-Istituto Oncologico della Svizzera Italiana (IOSI)
  Bellinzona, Switzerland Recruiting
• Kantonsspital Graubünden
  Chur, Switzerland Recruiting
• Les hôpitaux universitaires de Genève
  Geneva, Switzerland Recruiting
• Luzerner Kantonsspital
  Lucerne, Switzerland Recruiting

Study contacts

• Study coordinator: Lenka Vokálová, PhD
• Email: trials@swisscancerinstitute.ch
• Phone: +41 31 389 91 91

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.