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Which Pre-CAR-T chemo is safer? new trial aims to find out

NCT ID NCT07593482

Disease control Sponsor: Swiss Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests whether bendamustine causes fewer severe side effects than the standard fludarabine/cyclophosphamide combination when given before CAR-T cell therapy for B-cell lymphoma. About 92 people will be randomly assigned to one of the two chemotherapy regimens. The main goal is to see which approach leads to fewer serious complications like cytokine release syndrome, fever with low white blood cell counts, and nerve-related side effects within the first month after CAR-T infusion.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bendamustine hydrochloride, cyclophosphamide, fludarabine
What this could lead to
If bendamustine works better, it could become the standard pre-CAR-T chemotherapy, reducing severe side effects like cytokine release syndrome and infections.
What could go wrong
This is a small, early-phase trial (92 people) comparing two already-used drugs, so it may not show a clear winner. Side effects from both regimens are still possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 92 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

B-cell neoplasm diffuse large B-cell lymphoma follicular lymphoma high grade B-cell lymphoma large B-cell lymphoma marginal zone lymphoma primary mediastinal large B-cell lymphoma Richter transformation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B-cell lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    9 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Ente Ospedaliero Cantonale (EOC)-Istituto Oncologico della Svizzera Italiana (IOSI)

    Bellinzona, 6500, Switzerland

  • HOCH Health Ostschweiz - Kantonsspital St. Gallen

    Sankt Gallen, 9007, Switzerland

  • Inselspital Bern - Universitätsklinik für Medizinische Onkologie

    Bern, 3010, Switzerland

  • Kantonsspital Aarau

    Aarau, 5001, Switzerland

  • Kantonsspital Graubünden

    Chur, 7000, Switzerland

  • Klinik für Hämatologie und Onkologie Hirslanden Zürich

    Zurich, 8032, Switzerland

  • Les hôpitaux universitaires de Genève

    Geneva, 1211, Switzerland

  • Luzerner Kantonsspital

    Lucerne, 6004, Switzerland

  • Universitätsspital Basel

    Basel, 4056, Switzerland

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