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

Conditions

• Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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.
• Rituximab — DRUG
  Participants will receive IV rituximab as per protocol.

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) 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.

Key Dates

First listed

Oct 25, 2021

Start date

Mar 7, 2022

Status verified

Jul 2026

Primary completion

Feb 10, 2031

Completion

Feb 10, 2032

Study Design

Enrollment

332 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A
  Participants with R/R CLL/SLL after 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/SLL after two or more 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 up to the first three cycles of mosunetuzumab SC
• Experimental: Arm C (non-US participants only)
  Participants with R/R CLL/SLL after two or more prior lines of therapy and who have had prior exposure to BTKi and/or venetoclax will receive mosunetuzumab SC with venetoclax during dose escalation phase. Participants with R/R CLL/SLL after at least one prior line of therapy must have prior exposure to BTKi and/or venetoclax and \>12 months since last venetoclax exposure will receive mosunetuzumab SC with venetoclax during the dose expansion phase. During the dose expansion phase, a control cohort receiving the standard-of-care regimen of rituximab plus venetoclax has been added (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/ No attachments to email below.
  888-662-6728
  [email protected]
• Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (5)

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