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

Primary Investigator
Weiss, Jonathan
Status
OPEN TO ACCRUAL
Phase
III
NCT Number
NCT06742996
UM Number
2025.080
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Hematological Malignancies
ID (Protocol)
59261
Secondary Protocol No
HUM00276789
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Non-Hodgkin's Lymphoma
Summary
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.

Eligibility: Inclusion Criteria
  •   * Histologically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)
  •   * 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
  •   * 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.