About this trial
The researchers are doing this study to find out whether the combination of zanubrutinib, obinutuzumab, and sonrotoclax (BOSon) is an effective treatment approach for people with mantle cell lymphoma (MCL).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Documentation of disease: Patients must have pathologically confirmed MCL at the treating institution
Evaluable disease, stage II-IV
Age ≥ 65 years at screening
Comorbid disease(s) such as CAD, heart failure, pulmonary dysfunction, liver, or kidney dysfunction that precludes autoHCT based on expected increased morbidity
Disqualifiers
Active infection requiring parenteral antibiotic(s)
History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
Patients unable to swallow capsules or those with disease(s) or conditions significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic/active inflammatory bowel disease, or partial or complete bowel obstruction
Patients undergoing major surgery within 4 weeks of the first dose of study drug
Trial design
Single group
Treatments tested in this trial
Zanubrutinib
DrugPO twice daily of each 28-day cycle
Obinutuzumab
DrugIVPB on days 1, 8, and 15 of cycle 1; and IVPB on day 1 of cycles 2-8
Sonrotoclax
DrugSonrotoclax will be initiated on C2D1 using the ramp-up schedule
Treatment groups
Trial outcomes
Primary outcomes
evaluate BOSon
through determination of the PET CR-uMRD6 rate
Secondary outcomes
Proportion of Participants with Tumor Lysis Syndrome (TLS)
per Howard criteria
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
BeOne Medicines
Collaborator
Genentech, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options: