Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment

This multicenter, open-label, randomized controlled trial aims to evaluate the efficacy and safety of Orelabrutinib in combination with Bendamustine and Rituximab (OBR) versus Bendamustine and Rituximab (BR) in patients with intermediate- to high-risk mantle cell lymphoma (MCL) who are ineligible for transplantation. The primary objective is to assess the complete response (CR) rate during the induction phase, with secondary objectives including progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety. Exploratory analysis will investigate the correlati

Trial Details

NCT ID
NCT06496308
Phase
PHASE3
Sponsor
Ruijin Hospital
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Orelabrutinib
  • Bendamustine
  • Rituximab
  • Venetoclax
Locations (sample)
  • Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

  • Diagnosed with MCL (mantle cell lymphoma) through flow cytometry or histopathology, and has not received prior treatment.
  • Age \> 18 years of age, both genders are eligible.
  • Ann Arbor stage II-IV; for stage II subjects, those who require systemic therapy based on the investigator's judgment are eligible.
  • At least one measurable lesion.

For full eligibility, visit ClinicalTrials.gov.

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