Mantle Cell Lymphoma study: Sonrotoclax vs Zanubrutinib
Official title 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)
ClinicalTrials.gov ID: NCT06742996
What this study is testing
What is Sonrotoclax?
Sonrotoclax is an investigational medicine, taken by mouth, being studied as a potential treatment for mantle cell lymphoma.
Also referred to as BGB-11417.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out if adding sonrotoclax to zanubrutinib works better and is safe compared to zanubrutinib with a placebo.
- Who it's for
- Adults who have mantle cell lymphoma that has come back or did not respond to previous treatment.
- What's involved
- Participants will be given either sonrotoclax with zanubrutinib or a placebo with zanubrutinib and will have regular doctor visits and safety tests.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- Fresno, California, United States
- Irvine, California, United States
- New Haven, Connecticut, United States
- Pembroke Pines, Florida, United States
- Weston, Florida, United States
- Chicago, Illinois, United States
- Fort Wayne, Indiana, United States
- Waukee, Iowa, United States
- Baton Rouge, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Grand Rapids, Michigan, United States
- Rochester, Minnesota, United States
- Hattiesburg, Mississippi, United States
- St Louis, Missouri, United States
- Grand Island, Nebraska, United States
- Omaha, Nebraska, United States
+ 70 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Tucson, Arizona, United States; Fresno, California, United States; Irvine, California, United States; New Haven, Connecticut, United States; Pembroke Pines, Florida, United States and 84 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.