Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5

Study acronym: MorningLyte
StatusActive, Not Recruiting
PhasePhase 3
Started

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Record History

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  1. Minor Enrollment closed, study ongoing Show 4 more changesShow less
    • Trial sites reduced: 116 → 111 locations
    • Eligibility criteria expanded, about 41 words
    • Secondary endpoints: details revised at 6 of 35 entries
    • Study description expanded, about 4 words
  2. Minor Study sites: 49 to 116
    • Eligibility criteria expanded, about 162 words
    • Secondary endpoints: 36 to 35
    v5
  3. Minor Start date changed from estimate of May 2024 to Jun 7, 2024v4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Apr 2024 to May 2024
    • Site details revised at 49 of 49 sites
    v3
  5. Minor Re-verified, no change to tracked fieldsv2
  6. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is a phase III, randomized, open-label, international, multicenter, interventional trial, designed to compare the efficacy and safety of mosunetuzumab in combination with lenalidomide versus anti-CD20 monoclonal antibody (mAb) plus chemotherapy in patients with previously untreated FLIPI 2-5 follicular lymphoma.
Trial Details
NCT Number NCT06284122
Lead Sponsor The Lymphoma Academic Research Organisation
Collaborators: Lymphoma Study Association, Swiss Cancer Institute, Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Conditions
(from sponsor)
Follicular Lymphoma
Related terms Lymphoma, Follicular
Enrollment 790 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov