OncoMatch/Clinical Trials/NCT06284122

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

Is NCT06284122 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for follicular lymphoma.

Phase 3RecruitingThe Lymphoma Academic Research OrganisationNCT06284122Data as of May 2026

Treatment: Mosunetuzumab · Lenalidomide · Rituximab · Obinutuzumab · Cyclophosphamide · Doxorubicin · Vincristin · Prednisone · Rituximab · Obinutuzumab · Bendamustin — 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.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Biomarker criteria

Required: CD20 overexpression (positive)

CD20+ follicular lymphoma

Disease stage

Required: Stage ALL ANN ARBOR STAGES (Ann Arbor)

Grade: 123a (WHO 2016/2022)

All Ann Arbor stages (including stage I if FLIPI ≥ 2)

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: localized radiotherapy

Prior localized radiotherapy for the FL

Cannot have received: anti-cancer drug therapy

Use of any standard or experimental anti-cancer drug therapy within 42 days of the start (Day 1) of study treatment

Lab requirements

Blood counts

ANC ≥ 1 x 10^9/L; platelet count ≥ 75 x 10^9/L (≥ 30 x 10^9/L if bone marrow infiltration or splenomegaly); hemoglobin ≥ 8.0 g/dL unless related to bone marrow infiltration or splenomegaly

Kidney function

creatinine clearance ≥ 40 mL/min (MDRD or Cockcroft-Gault)

Liver function

AST or ALT ≤ 2.5 x ULN (≤ 5 x ULN if liver/pancreatic involvement); serum total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for Gilbert syndrome; ≤ 3 x ULN if liver/pancreatic involvement)

Cardiac function

LVEF within normal range (> 50% by TTE or > 45% by MUGA)

Adequate hematological function within 28 days prior to signing informed consent... Normal laboratory values: creatinine clearance ≥ 40 mL/min... AST or ALT ≤ 2.5 x ULN... serum total bilirubin ≤ 1.5 x ULN... LVEF within normal range

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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