A Pilot Study Evaluating Mosunetuzumab for Clearance of Detectable Minimal Residual Disease in Chronic Lymphocytic Leukemia
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
• 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 given as first- or second-line therapy for CLL.
∙ BCL2i-based regimens include venetoclax plus obinutuzumab (VO) or rituximab (VR), and the combination of a BTKi + a BCL2i +/- anti- CD20mAb.
⁃ If BCL2i was continued after the combination, the subject is not eligible.
• Detectable minimal residual disease (MRD) of ≥10e-4 in peripheral blood (PB) or bone marrow (BM) based on an NGS-based assay.
• Age ≥ 18 years
• ECOG performance status ≤ 2
• Adequate organ and bone marrow function as defined by the study protocol.
• Women of child-bearing potential must agree to remain abstinent or use highly effective contraception during the treatment period and for at least 3 months after the last dose of study therapy and tocilizumab.
• Men with female sexual partners of childbearing potential should agree to remain abstinent or use contraceptive measures which include a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for at least 1 month after the last dose of study therapy and 2 months after the last dose of tocilizumab. Men should refrain from donating sperm during the same period. Women should not donate oocytes. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
• Ability to take oral medications.
• Ability to understand and the willingness to sign a written informed consent document.