This study will assess the safety, tolerability, pharmaokinetics, and preliminary efficacy of mosunetuzumab (Lunsumio) monotherapy in participants with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This study will also allow participants who are currently progressing on a Bruton tyrosine kinase inhibitor (BTKi) and requiring salvage therapy as assessed by the treating physician to continue their BTKi throughout the screening period and for the first three cycles of mosunetuzumab. An additional arm (open to non-US participants only) has been added to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with venetoclax, a B-cell lymphoma 2 (BCL2) inhibitor, compared to standard-of-care rituximab plus venetoclax.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
332
Participants will receive subcutaneous (SC) mosunetuzumab.
Participants will receive intravenous (IV) tocilizumab as needed for cytokine release syndrome (CRS) events.
Participants will receive daily oral venetoclax.
Participants will receive IV rituximab as per protocol.
Mayo Clinic Rochester
Rochester, Minnesota, United States
RECRUITINGMemorial Sloan-Kettering Cancer Center
New York, New York, United States
WITHDRAWNThe James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
RECRUITINGUni of Texas - Md Anderson Cancer Center
Houston, Texas, United States
Rate of Dose-Limiting Toxicities (DLTs)
Time frame: From the first administration of mosunetuzumab until 21 days after the final mosunetuzumab step-up dose for Arms A, B, and C (up to 3 months)
Objective Response Rate (ORR) During Dose Expansion Phase
Time frame: Up to 8-12 weeks after the last dose of study drug
Objective Response Rate (ORR) During Dose Escalation Phase
Time frame: Up to 8-12 weeks after the last dose of study drug
Progression-Free Survival (PFS)
Time frame: From the first study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 12 months (Arms A and B) or 24 months (Arm C))
Overall Survival (OS)
Time frame: From the first dose of study drug to death from any cause (up to approximately 12 months (Arms A and B) or 24 months (Arm C))
Event-Free Survival (EFS)
Time frame: Between the date of the first study treatment to the date of disease progression/relapse, death, or start of new anti-leukemic therapy, whichever occurs first (up to approximately 12 months (Arms A and B) or 24 months (Arm C))
Complete Response (CR) Rate
Time frame: Up to 8-12 weeks after the last dose of study drug
Duration of Response (DOR)
Time frame: From the first occurrence of a documented objective response to disease progression by iwCLL 2018 criteria or death from any cause (up to approximately 12 months (Arms A and B) or 24 months (Arm C))
Duration of Complete Response (DOCR)
Time frame: From the first occurrence of a documented complete response to disease progression by iwCLL 2018 criteria or death from any cause (up to approximately 12 months (Arms A and B) or 24 months (Arm C))
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to approximately 12 months (Arms A and B) or 24 months (Arm C)
Maximum Serum Concentration (Cmax) of Mosunetuzumab SC
Time frame: Up to approximately 12 months (Arms A and B) or 24 months (Arm C)
Minimum Serum Concentration (Cmin) of Mosunetuzumab SC
Time frame: Up to approximately 12 months (Arms A and B) or 24 months (Arm C)
Time to Maximum Concentration (Tmax) of Mosunetuzumab SC
Time frame: Up to approximately 12 months (Arms A and B) or 24 months (Arm C)
Maximum Serum Concentration (Cmax) of BTKi or Venetoclax
Time frame: Up to approximately 12 months (Arms A and B) or 24 months (Arm C)
Minimum Serum Concentration (Cmin) of BTKi or Venetoclax
Time frame: Up to approximately 12 months (Arms A and B) or 24 months (Arm C)
Time to Maximum Concentration (Tmax) of BTKi or Venetoclax
Time frame: Up to approximately 12 months (Arms A and B) or 24 months (Arm C)
Incidence of Anti-Drug Antibodies (ADAs)
Time frame: Baseline through end of study (up to approximately 12 months for Arms A and B, or 24 months for Arm C)
Reference Study ID Number: BO43243 https://forpatients.roche.com/ No attachments to email below.
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Huntsman Cancer Institute at The University of Utah
Salt Lake City, Utah, United States
RECRUITINGPrincess Alexandra Hospital Woolloongabba
Woolloongabba, Queensland, Australia
RECRUITINGPeter MacCallum Cancer Center
East Melbourne, Victoria, Australia
COMPLETEDMonash Medical Centre
Melbourne, Victoria, Australia
RECRUITINGPeking University People's Hospital
Beijing, China
RECRUITINGSouthern Medical University Nanfang Hospital
Guangzhou, China
RECRUITING...and 21 more locations