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NCT05410418

Mosunetuzumab and Polatuzumab Vedotin for Untreated Follicular Lymphoma

StatusActive, Not Recruiting
PhasePhase 2
Primary completion
Track this trial

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Record History

All 10 versions: 8 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Results posted: Oct 28, 2026
    • Eligibility criteria expanded, about 60 words
    • Secondary endpoints revised (27)
    • Primary endpoint revised
  2. Primary completion date changed from estimate of May 31, 2026 to Sep 18, 2025
    • Study completion date: May 31, 2031 to Apr 24, 2029
    v9
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Oct 31, 2026 to May 31, 2026
    • Study completion date: Oct 31, 2031 to May 31, 2031
    • Site details revised
    v8
  4. Eligibility criteria expanded, about 6 words
    • Site contact updated
    v6
  5. Primary endpoints: 2 to 1
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: 23 to 27
    • Collaborators: 1 to 2
    v5
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Sep 30, 2026 to Oct 31, 2026
    • Study completion date: Sep 30, 2031 to Oct 31, 2031
    • Start date changed from estimate of Sep 30, 2022 to Oct 24, 2022
    • Site details revised
  2. Secondary endpoints: details revised at 2 of 23 entries
    • Eligibility criteria expanded, about 2 words
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Participants With Complete Response (CR) as Best Response
Timeframe: Through completion of treatment (estimated to be 1 year)

Secondary (19)

Number of Participants With Complete Response (CR)
Number of Participants With Partial Response (PR)
Number of Participants With Partial Response (PR) as Best Response
Overall Response Rate (ORR) as Measured by Number of Participants With Complete Response (CR) and Partial Response (PR)
Number of Participants With Stable Disease (SD)
Show 14 moreShow less
Number of Participants With Stable Disease (SD) as Best Response
Number of Participants With Progressive Disease (PD)
Number of Participants With Progressive Disease (PD) as Best Response
Time to First Response of Complete Response (CR) or Partial Response (PR)
Time to First Complete Response (CR)
Frequencies and Grades of Treatment-emergent Adverse Events (TEAEs)
Rate of Treatment Discontinuation Due to Treatment-emergent Adverse Events (TEAEs)
Percentage of Patients Requiring Any Tocilizumab Doses for Management of Cytokine Release Syndrome (CRS)
Number of Tocilizumab Doses Per Patient for Management of Cytokine Release Syndrome (CRS)
Progression-free Survival (PFS)
Overall Survival (OS)
Duration of First Response of Complete Response (CR) or Partial Response (PR)
Duration of First Complete Response (CR)
Time to Next Treatment (TTNT)

Arms and interventions

Mosunetuzumab and Polatuzumab VedotinExperimental

Patients receive CD3xCD20 bispecific antibody mosunetuzumab administered subcutaneously in combination with CD79b directed ADC polatuzumab vedotin administered intravenously. Mosunetuzumab and polatuzumab vedotin are given in combination for 6 cycles. Mosunetuzumab is given on Days 1, 8, and 15 of cycle 1 and then Day 1 thereafter, and polatuzumab vedotin is given on Day 1. After 6 cycles, patients continue on mosunetuzumab alone for 2 additional cycles. Patients undergo scans at the end of cycle 8, and if those scans show a complete response, patients will stop any further treatment and will enter follow-up. Patients with a partial response or stable disease on scans at the end of cycle 8 may receive up to 9 additional cycles of mosunetuzumab in the absence of disease progression or unacceptable toxicity. All cycles are planned to be 21 days.

Drugs: Mosunetuzumab, Polatuzumab vedotin

Sites

1 site in 1 country

  • Washington University School of MedicineSt Louis, Missouri, United States