OncoMatch/Clinical Trials/NCT06006117
Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma
Is NCT06006117 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for marginal zone lymphoma.
Treatment: Mosunetuzumab (SC) · Rituximab (R) · Bendamustine · CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) · Lenalidomide — This is an open label, multi-center, international, randomized phase III trial to compare the efficacy of Mosunetuzumab-Lenalidomide with investigator choices exclusively in R/R MZL patients. Patients with a proven diagnosis of EMZL, SMZL or NMZL subtypes and previously treated with at least one prior systemic treatment and not more than three prior lines are eligible. Previous treatment line must include at least one systemic line with a drug targeting CD20 (monoclonal antibody at least 2 cycles) with or without chemotherapy (R-CHOP, R-Bendamustine, R-CVP, R-Chlorambucil at least 2 cycles) or targeted treatment such as Ibrutinib. The patients will be Randomized as follows: Arm A - Experimental arm: • Mosunetuzumab-Lenalidomide Arm B - Comparator arms ( Investigator Choices): * Rituximab-Lenalidomide * Rituximab-Bendamustine * Rituximab-CHOP
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Disease stage
Excluded: Stage STAGE I EMZL, SMZL OR NMZL IF CANDIDATE TO LOCAL THERAPY
Stage I disease of EMZL, SMZL or NMZL may be eligible only if not candidate to local therapy (surgery or radiotherapy). Measurable disease in at least two perpendicular dimensions on an imaging scan is defined as: lymph node or nodal mass bi-dimensional measurement with ≥ 15 mm in longest transverse diameter or the short diameter must measure ≥ 10 mm regardless of the longest transverse diameter. Spleen is considered as a measurable disease if vertical axis is higher than 13 cm.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: CD20-targeted therapy — systemic
Previous line must include at least one systemic line with a drug targeting CD20 (monoclonal antibody at least 2 cycles; patient treated with monoclonal antibody monotherapy should have received at least 4 weekly injections)
Cannot have received: CD20/CD3-directed bispecific antibody (mosunetuzumab)
Treatment with mosunetuzumab or other CD20/CD3-directed bispecific antibodies
Cannot have received: allogeneic stem cell transplant
Allogeneic stem cell transplant
Lab requirements
Blood counts
Platelet count ≥ 75 G/L (≥ 30 G/L if cytopenia due to marrow involvement/hypersplenism/autoimmune thrombocytopenia); ANC ≥ 1 G/L unless neutropenia due to marrow involvement/hypersplenism; Total hemoglobin ≥ 8 g/dL unless anemia due to marrow involvement/hypersplenism/autoimmune hemolytic anemia
Kidney function
Measured or estimated creatinine clearance ≥ 40 mL/min by institutional standard method
Liver function
Serum total bilirubin ≤ 1.5 x ULN (or ≤3 x ULN for Gilbert syndrome); AST or ALT ≤ 2.5 x ULN, unless directly attributable to the patient's MZL
Adequate hematopoietic function at screening as follows unless cytopenia is clearly due to marrow involvement of MZL or hypersplenism or autoimmune thrombocytopenia: Platelet count ≥ 75 G/L; in cases of thrombocytopenia clearly due to marrow involvement of MZL or hypersplenism or auto-immune thrombocytopenia, platelet count should be ≥ 30 G/L. ANC ≥ 1 G/L unless neutropenia is clearly due to marrow involvement of MZL or hypersplenism. Total hemoglobin ≥ 8 g/dL unless anemia is clearly due to marrow involvement of MZL or hypersplenism or autoimmune hemolytic anemia. Serum total bilirubin ≤ 1.5 x ULN (or ≤3 x ULN for patients with Gilbert syndrome), AST or ALT ≤ 2.5 x ULN, unless directly attributable to the patient's MZL. Measured or estimated creatinine clearance ≥ 40 mL/min by institutional standard method.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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