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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Hoffmann-La Roche
Study ID
NCT05091424
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mosunetuzumab — DRUG
    Participants will receive subcutaneous (SC) mosunetuzumab
  • Tocilizumab — DRUG
    Participants will receive intravenous (IV) tocilizumab as needed for cytokine release syndrome (CRS) events.
  • Venetoclax — DRUG
    Participants will receive daily oral venetoclax

Study Details

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). 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 two 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.

Key Dates

Start date
Mar 7, 2022
Status verified
Jun 2026
Primary completion
Feb 10, 2031
Completion
Feb 10, 2032

Study Design

Enrollment
137 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Participants with R/R CLL who have failed two prior lines of therapy and who have had prior exposure to BTKi and/or venetoclax will receive mosunetuzumab subcutaneous (SC) monotherapy
  • Experimental: Arm B
    Participants with R/R CLL who have failed two prior lines of therapy, who are currently progressing on BTKi therapy, and who require salvage therapy as assessed by their treating physician will receive mosunetuzumab SC with BTKi overlap therapy for the first two cycles of mosunetuzumab SC
  • Experimental: Arm C (non-US participants only)
    Participants with R/R CLL who have failed two prior lines of therapy and who have had prior exposure to BTKi and/or venetoclax will receive mosunetuzumab SC with venetoclax (this arm is open only to participants outside of the US)

Primary Outcome Measure

Rate of Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to approximately 12 months (Arms A and B) or 24 months (Arm C) ]

Central Contacts

  • Reference Study ID Number: BO43243 https://forpatients.roche.com/
    888-662-6728
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (5)

FacilityCityStateZIPSite coordinators
Mayo Clinic RochesterRochesterMinnesota55902-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
The James Cancer Hospital and Solove Research InstituteColumbusOhio43210-
Uni of Texas - Md Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer Institute at The University of UtahSalt Lake CityUtah84112-

Find similar trials in Rochester, MN

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Mayo Clinic Rochester· Rochester, MNMemorial Sloan-Kettering Cancer Center· New York, NYThe James Cancer Hospital and Solove Research Institute· Columbus, OHUni of Texas - Md Anderson Cancer Center· Houston, TXHuntsman Cancer Institute at The University of Utah· Salt Lake City, UT

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