Comparing sonrotoclax plus zanubrutinib to placebo plus zanubrutinib for relapsed mantle cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the efficacy and safety of sonrotoclax combined with zanubrutinib compared to a placebo combined with zanubrutinib in adults suffering from relapsed or refractory mantle cell lymphoma (MCL). Participants will have received between one to five prior lines of systemic therapy and will be assessed for measurable disease. The study will monitor treatment outcomes and adverse effects to determine the potential benefits of the new combination therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama At Birmingham Hospital
  Birmingham, Alabama, United States Recruiting
• University of Arizona Cancer Center
  Tucson, Arizona, United States Recruiting
• Ucsf Fresno
  Fresno, California, United States Recruiting
• Kaiser Permanente Southern California
  Irvine, California, United States Recruiting
• Yale University Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• Memorial Cancer Institute, Memorial Healthcare System
  Pembroke Pines, Florida, United States Recruiting

+95 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.com
• Phone: 1.877.828.5568

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sonrotoclax and Zanubrutinib With CAR-T in Mantle Cell Lymphoma

  This trial tests whether adding two oral drugs, sonrotoclax and zanubrutinib, to standard CAR-T therapy helps people with mantle cell lymphoma who have relapsed or are refractory after prior treatment.

  Recruiting at 5 sites Phase 2 Canadian Cancer Trials Group · Calgary, Alberta and 4 other locations · NCT07341191

• Zanubrutinib plus rituximab for secondary HLH linked to B‑cell lymphoma

  This test tries zanubrutinib together with rituximab (plus short steroids and ruxolitinib, with emapalumab if needed) to treat people who have secondary HLH caused by B‑cell lymphoma.

  Recruiting Phase 4 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07270835

• Obinutuzumab plus zanubrutinib and lenalidomide as first treatment for mantle cell lymphoma

  This trial will test whether a combination of obinutuzumab, zanubrutinib, and lenalidomide (with CAR‑T offered for high‑risk patients) works as a first‑line option for people newly diagnosed with mantle cell lymphoma.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality and 1 other locations · NCT07261163

• Bendamustine–Rituximab–Cytarabine plus Zanubrutinib induction followed by zanubrutinib/rituximab with or without sonrotoclax maintenance for newly diagnosed mantle cell lymphoma

  This trial tests whether giving zanubrutinib with a bendamustine‑rituximab‑cytarabine induction and then continuing zanubrutinib with rituximab, with or without sonrotoclax, helps people with newly diagnosed mantle cell lymphoma stay in remission longer.

  Recruiting at 4 sites Phase 2 Dana-Farber Cancer Institute · Phoenix, Arizona and 6 other locations · NCT06854003

• Combination treatment for chronic lymphocytic leukemia and lymphoma

  This study is testing a new combination treatment with sonrotoclax and either zanubrutinib or rituximab to see if it can help patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, and mantle cell lymphoma.

  Recruiting Phase 2 Fred Hutchinson Cancer Center · Seattle, Washington · NCT06839053

• Treatment for relapsed or refractory B-cell lymphoma using SynKIR-310

  This study is testing a new treatment called SynKIR-310 to see if it can help adults with relapsed or refractory B-cell lymphoma feel better.

  Recruiting at 5 sites Phase 1 Verismo Therapeutics · Denver, Colorado and 4 other locations · NCT06544265

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.