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

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 rou

Trial Details

NCT ID
NCT07593482
Phase
PHASE2
Sponsor
Swiss Cancer Institute
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • bendamustine hydrochloride
  • Cyclophosphamide
  • Fludarabine
Locations (sample)
  • Aarau, Switzerland|47.39254,8.04422
  • Basel, Switzerland|47.55839,7.57327
  • Bellinzona, Switzerland|46.19278,9.01703
  • Bern, Switzerland|46.94809,7.44744
  • Chur, Switzerland|46.84986,9.53287

Key Eligibility 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 determin…
  • Planned treatment with commercially available CAR-T cell product
  • Age ≥18 years
  • Ability to provide written informed consent

For full eligibility, visit ClinicalTrials.gov.

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