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

Sponsor
The Lymphoma Academic Research Organisation
Study ID
NCT06284122
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Mosunetuzumab — DRUG
    5 mg (step-up dosing) Day 1 of C1 45 mg Day 8 and Day 15 of C1, 45 mg Day 1 from C2 to C12, 45 mg Day 1 from C13 to C21
  • Lenalidomide — DRUG
    Lenalidomide starting dose is based on patient's creatinine clearance. Day 1 to Day 21 from C2 to C12
  • Rituximab — DRUG
    when associated to CHOP IV 375mg/m² SC 1400 mg allowed from C2 Day 1 of C1 Day 1 from C2 to C6 Day 1 from C7 to C20
  • Obinutuzumab — DRUG
    when associated to CHOP 1000 mg Day 1, Day 8, Day 15 of C1 Day 1 from C2 to C8 Day 1 from C9 to C18
  • Cyclophosphamide — DRUG
    750 mg/m2 Day 1 from C1 to C6
  • Doxorubicin — DRUG
    50 mg/m2 Day 1 from C1 to C6
  • Vincristin — DRUG
    1.4 mg/m2 (cap cf. below)$ Day 1 from C1 to C6
  • Prednisone — DRUG
    100 mg/day Day 1 to Day 5 from C1 to C6
  • Rituximab — DRUG
    when associated to bendamustin IV 375mg/m² SC 1400 mg allowed from C2 Day 1 of C1 Day 1 from C2 to C6 Day 1 from C7 to C18
  • Obinutuzumab — DRUG
    when associated to bendamustin 1000 mg Day 1, Day 8, Day 15 of C1 Day 1 from C2 to C8 Day 1 from C9 to C20
  • Bendamustin — DRUG
    90 mg/m2 Day 1 and Day 2 from C1 to C6

Study Details

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.

Key Dates

Start date
Jun 7, 2024
Status verified
Jun 2026
Primary completion
Nov 30, 2028
Completion
Apr 30, 2034

Study Design

Enrollment
790 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mosun-Len
    Mosunetuzumab + lenalidomide
  • Active Comparator: R-CHOP
    Rituximab-CHOP
  • Active Comparator: G-CHOP
    Obinutuzumab-CHOP
  • Active Comparator: R-Benda
    Rituximab-Bendamustin
  • Active Comparator: G-Benda
    Obinutuzumab-Bendamustin

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 130 PFS events assessed by an Independent Review Committee (IRC) (4.6 years) ]

Central Contacts

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