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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 (Jun 2026). This Phase 3 trial studies multiple treatments for follicular lymphoma.

Phase 3RecruitingThe Lymphoma Academic Research OrganisationNCT06284122Data as of Jun 2026Location: International · 5 countries

Treatment: Mosunetuzumab · Lenalidomide · Rituximab · Obinutuzumab · Cyclophosphamide · Doxorubicin · Vincristin · Prednisone · Rituximab · Obinutuzumab · BendamustinThis 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

Treatments studied

Immunotherapy

MosunetuzumabRituximabObinutuzumabRituximabObinutuzumab

Chemotherapy

CyclophosphamideDoxorubicin

Endocrine / hormonal

Lenalidomide

Other

VincristinPrednisoneBendamustin

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.

Frequently asked questions

Is NCT06284122 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require CD20?

Yes, CD20 overexpression is a required biomarker for enrollment.

What disease stage is eligible?

Stage ALL ANN ARBOR STAGES is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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