A Pilot Study Evaluating Mosunetuzumab for Clearance of Detectable Minimal Residual Disease in Chronic Lymphocytic Leukemia
Inhye Ahn
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
Description
This is open-label, multicenter, pilot study of mosunetuzumab given alone or in combination with a BTKi in participants with CLL/SLL. Participants who are already taking a BTKi will continue the BTKi while receiving Mosunetuzumab on this study. Participants who have been previously treated with a drug called B-cell lymphoma 2 inhibitor (BCL2i) will receive Mosunetuzumab alone. Treatment with mosunetuzumab is given up to 17 cycles (approximately 1 year). Patients who achieve early MRD clearance will stop mosutuzumab after 8 cycles (approximately 6 months).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugMosunetuzumab
Subcutaneous injection of a CD20xCD3 bispecific antibody
- DrugIbrutinib
For participants who have been ibrutinib PO prior to enrollment
- DrugAcalabrutinib
For participants who have been acalabrutinib PO prior to enrollment
- DrugZanubrutinib
For participants who have been zanubrutinib PO prior to enrollment
- DrugPirtobrutinib
For participants who have been pirtobrutinib PO prior to enrollment
Locations (2)
- Brigham & Women's HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts