Orelabrutinib Plus Lisaftoclax and Rituximab in Untreated Mantle Cell Lymphoma With High-Risk Disease

This multicenter, open-label, trial aims to evaluate the efficacy and safety of orelabrutinib plus lisaftoclax and rituximab in patients with high-risk mantle cell lymphoma (MCL). The primary objective is to assess the optimal 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 ID
NCT07272499
Phase
PHASE2
Sponsor
Ruijin Hospital
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Orelabrutinib
  • Rituximab (R)
  • Lisaftoclax (APG-2575)
Locations (sample)
  • Shanghai, Shanghai Municipality, 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 \> 14 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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