A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)

The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.

Trial Details

NCT ID
NCT06742996
Phase
PHASE3
Sponsor
BeOne Medicines
Status
RECRUITING
Cancer Type
Non-Hodgkin Lymphoma Lymphoma
Interventions
  • Sonrotoclax
  • Zanubrutinib
  • Placebo
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Fresno, California, United States|36.74773,-119.77237
  • Irvine, California, United States|33.66946,-117.82311
  • New Haven, Connecticut, United States|41.30815,-72.92816

Key Eligibility Criteria

  • Histologically locally confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5),…
  • Ability to provide archival or fresh tumor tissue for retrospective central confirmation of MCL diagnosis
  • Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requ…
  • Relapsed or refractory disease after the last line of therapy

For full eligibility, visit ClinicalTrials.gov.

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