# Mosunetuzumab with lenalidomide in relapsed marginal zone lymphoma

Source: https://onco.cc/trials/mosun-len-mzl/  
OnCo record `mosun-len-mzl` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A European trial for a lymphoma that rarely gets its own study, testing a two-headed antibody with a tablet against the three combinations doctors currently choose between.

## Summary

Marginal zone lymphoma is usually studied as a minority arm inside follicular lymphoma trials, which is why so little of its treatment rests on randomised evidence. This trial is run exclusively in it, across Belgium, France, Germany, Italy and Portugal, and takes all three marginal zone subtypes: extranodal, splenic and nodal.

Participants have had at least one and no more than three prior systemic lines, including at least two cycles of a CD20-directed antibody with or without chemotherapy, or a targeted treatment such as ibrutinib. They are randomised between subcutaneous mosunetuzumab with lenalidomide 20 mg daily on days 1 to 21 of cycles 2 to 6, and an investigator's choice declared before randomisation of rituximab with lenalidomide, rituximab with bendamustine, or R-CHOP. Randomisation is stratified by marginal zone subtype and by whether progression after first-line treatment occurred within two years.

The primary endpoint is investigator-assessed progression-free survival by the Lugano 2014 criteria, with primary completion estimated for September 2027. Stratifying by early progression is the design detail that matters: it is the first time a marginal zone trial has treated the two-year progression marker as a planned subgroup rather than an afterthought.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-10-01
- Also known as: Mosunetuzumab-lenalidomide in marginal zone lymphoma
- Tags: lymphoma-evidence
- Registry id: NCT06006117
- Phase: 3
- Setting: Relapsed or refractory marginal zone lymphoma after one to three prior lines: mosunetuzumab with lenalidomide against the investigator's choice of rituximab with lenalidomide, bendamustine or CHOP
- Sponsor: The Lymphoma Academic Research Organisation
- Enrolled: 260

## Sources

- ClinicalTrials.gov NCT06006117: https://clinicaltrials.gov/study/NCT06006117

## Connected records

- cancers: [Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma)](https://onco.cc/cancers/malt-lymphoma/), [Marginal zone lymphoma](https://onco.cc/cancers/marginal-zone-lymphoma/), [Nodal marginal zone lymphoma](https://onco.cc/cancers/nodal-marginal-zone-lymphoma/), [Non-Hodgkin lymphoma (all types)](https://onco.cc/cancers/non-hodgkin-lymphoma/), [Splenic marginal zone lymphoma](https://onco.cc/cancers/splenic-marginal-zone-lymphoma/)
- fronts: [Immunotherapy](https://onco.cc/fronts/immunotherapy/)
- technologies: [Bispecific antibodies](https://onco.cc/technologies/bispecific-antibody/), [T-cell engagers (bispecific)](https://onco.cc/technologies/t-cell-engager/)
- targets: [CD20](https://onco.cc/targets/cd20/), [CD3](https://onco.cc/targets/cd3/)
- drugs: [Bendamustine](https://onco.cc/drugs/bendamustine/), [Cyclophosphamide](https://onco.cc/drugs/cyclophosphamide/), [Doxorubicin](https://onco.cc/drugs/doxorubicin/), [Lenalidomide](https://onco.cc/drugs/lenalidomide/), [Mosunetuzumab](https://onco.cc/drugs/mosunetuzumab/), [Prednisone](https://onco.cc/drugs/prednisone/), [Rituximab](https://onco.cc/drugs/rituximab/), [Vincristine](https://onco.cc/drugs/vincristine/)
- companies: [LYSA (The Lymphoma Study Association)](https://onco.cc/companies/lysa/)
- terms: [Lugano classification / Ann Arbor staging](https://onco.cc/terms/lugano-classification/), [POD24: progression of follicular lymphoma within two years, and why it changes the plan](https://onco.cc/terms/lymphoma-tx-pod24/), [R-CHOP (lymphoma chemoimmunotherapy)](https://onco.cc/terms/r-chop/)
- bottlenecks: [Rare and paediatric cancers without markets](https://onco.cc/bottlenecks/b-rare-cancers/), [Trials enrol too few, too slowly](https://onco.cc/bottlenecks/b-trial-enrolment/)
- key papers: [Early relapse of follicular lymphoma after R-CHOP defines patients at high risk for death: an analysis from the National LymphoCare Study](https://onco.cc/key-papers/paper-casulo-pod24-follicular-lymphoma-jco-2015/)
- roadmaps: [Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting](https://onco.cc/roadmaps/lymphoma-roadmap/)
- ideas: [Fixed-duration, chemotherapy-free first-line treatment for the indolent lymphomas](https://onco.cc/ideas/lymphoma-ev-fixed-duration-chemotherapy-free-first-line/)

---
JSON: https://onco.cc/api/v1/entities/mosun-len-mzl.json