Recruiting NCT06742996

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)

Phase III Interventional Mantle Cell Lymphoma B Cell Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Sonrotoclax, Zanubrutinib, Placebo.
Who it may be relevant to: Registry conditions: Mantle Cell Lymphoma, B Cell Lymphoma. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Brazil +12
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma

Overview

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.

Detailed description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Interventions

Drug Sonrotoclax
Administered orally
Drug Zanubrutinib
Administered orally
Drug Placebo
Administered orally

Primary outcome measures

Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) [Time frame: Approximately 41 months]

Secondary outcome measures (10)

Overall Survival (OS) [Time frame: Approximately 92 months]
PFS as assessed by investigator (INV) [Time frame: Approximately 58 months]
Overall Response Rate (ORR) as assessed by BIRC and by INV [Time frame: Approximately 58 months]
Duration of Response (DOR) as assessed by BIRC and by INV [Time frame: Approximately 58 months]
Complete Response Rate (CRR) as assessed by BIRC and by INV [Time frame: Approximately 58 months]
Time to first response as assessed by BIRC and by INV [Time frame: Approximately 58 months]
Time to initiation of new anticancer therapy [Time frame: Approximately 58 months]
Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Non-Hodgkin Lymphoma High Grade Module 29 (EORTC-QLQ-NHL-HG29) [Time frame: Approximately 58 months]
Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) [Time frame: Approximately 58 months]
Number of participants with treatment-emergent adverse events (TEAEs) [Time frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 58 months]

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 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 requiring treatment in the opinion of the investigator
Relapsed or refractory disease after the last line of therapy
Measurable disease defined as ≥ 1 nodal lesion that is > 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is > 1 cm in longest diameter
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
Adequate organ function

Exclusion criteria

Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i)
Prior therapy with BTK degraders
Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi. Participants with refractory disease to BTKi therapy or relapse attributed to failure of BTKi therapy are ineligible.
Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug
Known central nervous system involvement by lymphoma
Clinically significant cardiovascular disease
History of stroke or intracranial hemorrhage within 6 months before first dose of study drug

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment

Study locations

United States · 41 centers

University of Alabama At Birmingham Hospital — Birmingham
University of Arizona Cancer Center — Tucson
Ucsf Fresno — Fresno
Kaiser Permanente Southern California — Irvine
Yale University Yale Cancer Center — New Haven
Memorial Cancer Institute, Memorial Healthcare System — Pembroke Pines
Cleveland Clinic Florida — Weston
Rush University Medical Center — Chicago
… and 33 more centers

China · 20 centers

Beijing Cancer Hospital — Beijing
Beijing Hospital — Beijing
The First Affiliated Hospital of Chongqing Medical University — Chongqing
Sun Yat Sen University Cancer Center — Guangzhou
Nanfang Hospital, Southern Medical University — Guangzhou
Harbin Medical University Cancer Hospital — Harbin
The First Affiliated Hospital of Zhengzhou University — Zhengzhou
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan
… and 12 more centers

Japan · 18 centers