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Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 correlation between tumor biomarkers and treatment efficacy.
Trial Details
NCT Number NCT06496308
Lead Sponsor Ruijin Hospital
Collaborators: The Third Xiangya Hospital of Central South University, Anhui Provincial Cancer Hospital, Fujian Medical University Union Hospital, Yantai Yuhuangding Hospital, Huadong Hospital Affiliated with Fudan University, Shanghai, The First Affiliated Hospital of Anhui Medical University, Jiangxi Provincial Cancer Hospital, Fujian Cancer Hospital
Conditions Mantle Cell Lymphoma (MCL)
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov