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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 1\. Patient with histologically proven previously untreated CD20+ follicular lymphoma grade 1, 2, or 3a (including patient watched during up to 10 years after initial diagnosis) as assessed by the investigators according to the WHO 2016 classification12, or classical follicular lymphoma according to the WHO 2022 classification13. Diagnostic tissue must be available for central pathology review, exploratory endpoints and secondary data use.
. FLIPI 2-5.
. All Ann Arbor stages (including stage I if FLIPI ≥ 2).
. Must need treatment as evidenced by at least one of the following criteria:
.1. Bulky disease defined as one of the following: 4.1.1. a nodal or extranodal mass/lesion \> 70 mm in its largest diameter or, 4.1.2. involvement of at least 3 different nodal or extranodal sites (each with a diameter greater than \> 30 mm) 4.2. Presence of at least one of the following B symptoms within the prior 6 months: 4.2.1. fever (\> 38°C) of unclear etiology 4.2.2. night sweats 4.2.3. weight loss greater than 10% 4.3. Symptomatic splenomegaly 4.4. Symptomatic lesion: 4.4.1. painful lesion and/or 4.4.2. any compressive syndrome (for example, but not restricted to- ureteral, orbital, gastrointestinal) 4.5. Any one of the following cytopenias due to lymphoma: 4.5.1. hemoglobin \< 10g/dL (6.25 mmol/L) 4.5.2. platelets \<100 x 109/L, or 4.5.3. absolute neutrophil count (ANC) \< 1.5 x 109/L 4.6. Pleural or peritoneal serous effusion (irrespective of cell content) 4.7. Abnormal biological prognostic parameters: (item not applicable for Germany) 4.7.1. β2microglobulin \> ULN or 4.7.2. LDH \> ULN
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: 130 PFS events assessed by an Independent Review Committee (IRC) (4.6 years)
2
Progression Free Survival (PFS)
Timeframe: 173 PFS events assessed by IRC (5.8 y)
Trial details
NCT IDNCT06284122
SponsorThe Lymphoma Academic Research Organisation
. At least one bi-dimensionally measurable nodal lesion, defined as \> 15 mm in its longest dimension, or at least one bi-dimensionally measurable extra nodal lesion, defined as \> 10 mm in its longest dimension (and FDG-avid lesion).
. Participant who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures.
. Must be ≥ 18 years old at the time of signing the informed consent form (ICF).
Exclusion criteria
. Grade 3b follicular lymphoma according to the WHO 2016 classification12, or follicular large B-cell lymphoma according to the WHO 2022 classification13
. Suspicion or clinical evidence of transformed lymphoma at enrollment by investigator assessment.
. Prior localized radiotherapy for the FL.
. Prior history of another lymphoma.
. Uncontrolled symptomatic pleural or serous effusion requiring urgent treatment (within one week of finding). Participants may only be enrolled after Coordinating investigator / sponsor approval once confirmed participant is durably asymptomatic after adequate pleural/serous drainage or only if an efficient drainage device (e.g.pleurX™) is in place before randomization.
. Uncontrolled symptomatic ureterohydronephrosis resulting in renal failure. Participants with adequate management i.e. ureteral catheter or double J stent allowing renal failure control are eligible only if urinary catheter is in place before randomization.
. Presence or history of symptomatic or threatening lymphomatous epidural/nerve root lesion, even such participants whose disease is controlled by short course of steroids are NOT eligible.
. Use of any standard or experimental anti-cancer drug therapy within 45 days of the start (Day 1) of study treatment.