Mosunetuzumab for CLL MRD Clearance
The goal of this study is to test mosunetuzumab given alone or in combination with a Bruton tyrosine kinase inhibitor (BTKi, such as ibrutinib, acalabrutinib, zanubrutinib, or pirtobrutinib) in participants with CLL (chronic lymphocytic leukemia) or small lymphocytic lymphoma (SLL). The names of the study drugs in this
| Condition(s) | Leukemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Lymphoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | The goal of this study is to test mosunetuzumab given alone or in combination with a Bruton tyrosine kinase inhibitor (BTKi, such as ibrutinib, acalabrutinib, zanubrutinib, or pirtobrutinib) in participants with CLL (chronic lymphocytic leukemia) or small lymphocytic lymphoma (SLL). The names of the study drugs in this research study are: * Mosunetuzumab * BTK inhibitor: Ibrutinib, acalabrutinib, zanubrutinib, or pirtobrutinib |
| Who can participate | Key Inclusion Criteria: * Meet 2018 iwCLL guidelines for the diagnosis of CLL or SLL * Recent completion of treatment or ongoing treatment for CLL/SLL as follows: * BTKi arm: On continuous BTKi therapy for \> 12 months, including \> 2 months at a stable dose. * BTKis include ibrutinib, acalabrutinib, zanubrutinib and pirtobrutinib. * The BTKi is the first- or second-line therapy for CLL. * BCL2i arm: Completed BCL2i-based therapy \< 12 months of enrollment. * BCL2i-based therapy must be the most recent CLL therapy prior to enrollment. * BCL2i must have been given for at least 6 months for patients who were intolerant to a BCL2i and stopped the treatment without disease progression. For all others, at least 12 cycles of BCL2i therapy are required. * BCL2i-based therapy should have been give |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Inhye Ahn |
| Locations | Boston, Massachusetts, United States; Boston, Massachusetts, United States |
| Start date | 2025-11-24 |
| NCT ID | NCT07052695 |
| Official listing | https://clinicaltrials.gov/study/NCT07052695 |