OncoMatch/Clinical Trials/NCT06006117
Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma
Is NCT06006117 recruiting? Yes, currently enrolling (Sep 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
Treatments studied
Immunotherapy
Chemotherapy
Endocrine / hormonal
Other
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy
Have been treated with at least one prior systemic treatment and not more than three prior lines
Must have received: CD20-targeted monoclonal antibody
Previous line must include at least one systemic line with a drug targeting CD20 (monoclonal antibody at least 2 cycles; participants treated with monoclonal antibody monotherapy should have received at least 4 weekly injections)
Cannot have received: mosunetuzumab or other CD20/CD3-directed bispecific antibody
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, or autoimmune thrombocytopenia); ANC ≥ 1 G/L (unless neutropenia due to marrow involvement or hypersplenism); Total hemoglobin ≥ 8 g/dL (unless anemia due to marrow involvement, hypersplenism, or 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 MZL
Cardiac function
LVEF within normal range (> 50% by TTE or > 45% by MUGA scan)
Adequate hematopoietic function at screening...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 MZL; Measured or estimated creatinine clearance ≥ 40 mL/min; LVEF within normal range (> 50% by TTE or > 45% by MUGA scan)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06006117 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior mosunetuzumab or other CD20/CD3-directed bispecific antibody, allogeneic stem cell transplant disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages