A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia

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 bee

Trial Details

NCT ID
NCT05091424
Phase
PHASE1
Sponsor
Hoffmann-La Roche
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Mosunetuzumab
  • Tocilizumab
  • Venetoclax
  • Rituximab
Locations (sample)
  • Rochester, Minnesota, United States|44.02163,-92.4699
  • New York, New York, United States|40.71427,-74.00597
  • Columbus, Ohio, United States|39.96118,-82.99879
  • Houston, Texas, United States|29.76328,-95.36327
  • Salt Lake City, Utah, United States|40.76078,-111.89105

Key Eligibility Criteria

  • Have a diagnosis of CLL requiring treatment according to the International Workshop on CLL (iwCLL) criteria (Hallek et al 2018)
  • Eastern Cooperative Oncology Group (ECOG) performance score (PS) of ≤ 2
  • Adequate bone marrow (BM) function independent of growth factor or transfusion support, within 2 weeks of screening, at screening as defined by the…
  • Adequate liver function unless directly attributable to the participant's CLL

For full eligibility, visit ClinicalTrials.gov.

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