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NCT Number: NCT07278921

Study to Evaluate the Response to Treatment With Mosunetuzumab in Relapsed/Refractory Follicular Lymphoma (FL) After at Least Two Lines of Therapy, Within the Compassionate Use Program (CUP).

Retrospective, multicenter observational study to evaluate the response to treatment with Mosunetuzumab in relapsed/refractory Follicular Lymphoma (FL) after at least three lines of therapy, within the Compassionate Use Program (CUP).

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Key information

Conditions

Relapsed/Refractory Follicular Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location status: Recruiting

Location contact

Prof. Andrés JM Ferreri

CONTACT

[email protected]

02-2643- 9396

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (>18 years) with follicular non-Hodgkin's lymphoma, undergoing at least two lines of therapy, treated with mosunetuzumab under a compassionate use program.
  • Patients who have signed informed consent for treatment.

Exclusion criteria

  • Age <18 years
  • Patients with other types of cancer/lymphoma
  • Patients not eligible for the Mosunetuzumab compassionate use program

Treatment and study plan

Mosunetuzumab

Drug

Adult patients (>18 years) with Follicular Non-Hodgkin Lymphoma, who have undergone at least two lines of therapy, treated with Mosunetuzumab under a compassionate use program

Primary outcomes

  1. Evaluate the response to Mosu (Lugano criteria)

    Time frame: Up to 1 year from treatment initiation

    The primary objective of the study is to evaluate the response to mosunetuzumab in patients diagnosed with follicular lymphoma from second-line therapy, within the national compassionate use program (CUP). This response is assessed according to the 2014 Lugano criteria.

  2. Disease-free survival (PFS)

    Time frame: 1 year after starting treatment (PFS at 1 year)

    Disease-free survival (PFS) at 1 year is evaluated.

Secondary outcomes

  1. OS

    Time frame: 12 month

    The study's secondary objective is to evaluate the overall survival (OS) of the included patients.

  2. rate of toxicity

    Time frame: 12 months

    Analyze the rate of toxicity recorded during therapy, with particular attention to infusion reactions, CRS, and ICANS.

Study contacts

Contact information is provided by the study sponsor or research team.

Andres JM Ferreri, Prof

CONTACT

[email protected]

0226439396

Sponsors and collaborators

Lead sponsor

Andrés José Maria Ferreri

Other

Registry information

Official study title

Retrospective, Multicenter Observational Study to Evaluate the Response to Treatment With Mosunetuzumab in Relapsed/Refractory Follicular Lymphoma (FL) After at Least Two Lines of Therapy, Within the Compassionate Use Program (CUP).

Acronym: MosuOSSHSR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2025
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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