A Phase 2 Study of Zanubrutinib, Obinutuzumab, and Sonrotoclax in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Massachusetts General Hospital
Summary
The purpose of this study is to determine the proportion of participants who achieve undetectable measurable residual disease (uMRD) in previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Description
This is a multicenter phase II study evaluating zanubrutinib, obinutuzumab, and sonrotoclax in previously untreated patients with CLL or SLL. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved sonrotoclax as a treatment for any disease. The U.S. Food and Drug Administration (FDA) has approved zanubrutinib and obinutuzumab as a treatment option for your disease. The combination…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant must have CLL or SLL (WHO criteria). * Participant must require treatment according to iwCLL guidelines. * Participants must have no prior systemic therapy for CLL or SLL, except: * Prior local radiation for symptomatic disease is permitted. * Short course systemic corticosteroids is permissible for disease control, improvement of performance status, or non-cancer indication. However, duration of steroid course must be ≤14 days with maximum daily dose of ≤100 mg prednisone, ≤20 mg dexamethasone, or equivalent, and must be discontinued prior to study trea…
Interventions
- DrugZanubrutinib
Bruton's Tyrosine Kinase (BTK) inhibitor
- DrugSonrotoclax
B-cell lymphoma 2 (BCL2) protein inhibitor
- DrugObinutuzumab
Anti-CD20 monoclonal antibody
Locations (2)
- Massachusetts General HospitalBoston, Massachusetts
- Memorial Sloan Kettering Cancer CenterNew York, New York