Sonrotoclax Plus Zanubrutinib for Mantle Cell Lymphoma

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)

Recruiting Phase 3 Interventional Study
Mantle Cell Lymphoma B Cell Lymphoma
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
BeOne Medicines · Industry
Who this trial is looking for

This trial is looking for adults with mantle cell lymphoma who have not responded to treatment. Participants will receive a combination of sonrotoclax and zanubrutinib, or just zanubrutinib with a placebo.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with mantle cell lymphoma.
  • I can provide a tissue sample for testing.
  • I have had 1 to 5 previous treatments for my lymphoma.
  • I have measurable lymphoma that has not been treated effectively.
  • My performance status is between 0 to 2.
  • My organs are functioning well.

You may not be able to join if

  • I have previously taken a B-cell lymphoma-2 inhibitor.
  • I have previously taken BTK degraders.
  • I have previously taken any Bruton tyrosine kinase inhibitor unless I could not tolerate it.
  • I have had stem cell therapy within 3 months of starting this study.
  • I have had an allogeneic stem cell transplant within 6 months of starting this study.
  • I have central nervous system involvement by lymphoma.
  • I have significant heart disease.
  • I have had a stroke or brain bleed within the last 6 months.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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 Locations
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Eligibility Criteria
Inclusion Criteria: * Histologically locally confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC) * Ability to provide archival or fresh tumor tissue for retrospective ce…
Contacts

Study Director

1.877.828.5568

clinicaltrials@beonemed.com

CONTACT