A Study of Zanubrutinib, Obinutuzumab, and Sonrotoclax in People With Mantle Cell Lymphoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Zanubrutinib

    Drug

    PO twice daily of each 28-day cycle

  • Obinutuzumab

    Drug

    IVPB on days 1, 8, and 15 of cycle 1; and IVPB on day 1 of cycles 2-8

  • Sonrotoclax

    Drug

    Sonrotoclax will be initiated on C2D1 using the ramp-up schedule

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Zanubrutinib, Obinutuzumab, and SonrotoclaxExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

evaluate BOSon

through determination of the PET CR-uMRD6 rate

Time frame
up to 3 years

Secondary outcomes

1

Proportion of Participants with Tumor Lysis Syndrome (TLS)

per Howard criteria

Time frame
up to 3 years

Other outcomes

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: