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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Swiss Cancer Institute • ClinicalTrials.gov ID: NCT07593482

Registry updated: 2026-10-16
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Description

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).

Interventions

  • bendamustine hydrochloride (Drug)
    * 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 (Drug)
    * 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 (Drug)
    * 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.

Eligibility criteria

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.

Conditions

B-cell Lymphoma

Locations

  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record