NCT07593482 Bendamustine Versus Fludarabine/Cyclophosphamide for Lymphodepletion in Chimeric Antigen Receptor T-cell Immunotherapy (CAR-T): a Randomized Trial.
| NCT ID | NCT07593482 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Swiss Cancer Institute |
| Condition | B-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2026-09-24 |
| Primary Completion | 2029-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 92 participants in total. It began in 2026-09-24 with a primary completion date of 2029-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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.
Contact & Investigator
Benjamin Kasenda, PD Dr. med. Dr. phil.
STUDY CHAIR
University Hospital Basel (USB)
Frequently Asked Questions
Who can join the NCT07593482 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying B-cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07593482 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07593482 currently recruiting?
Yes, NCT07593482 is actively recruiting participants. Contact the research team at trials@swisscancerinstitute.ch for enrollment information.
Where is the NCT07593482 trial being conducted?
This trial is being conducted at Aarau, Switzerland, Basel, Switzerland, Bellinzona, Switzerland, Bern, Switzerland and 5 additional locations.
Who is sponsoring the NCT07593482 clinical trial?
NCT07593482 is sponsored by Swiss Cancer Institute. The principal investigator is Benjamin Kasenda, PD Dr. med. Dr. phil. at University Hospital Basel (USB). The trial plans to enroll 92 participants.