RecruitingPhase 2NCT05849857

Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries

Phase II Multicenter Clinical Trial: Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries


Sponsor

Oslo University Hospital

Enrollment

80 participants

Start Date

Sep 11, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

In this clinical trial adult patients diagnosed with follicular lymphoma and relapse or progression of disease within 24 months of starting first line treatment will be treated with mosunetuzumab. This is a bispecific antibody, a new type of immunotherapy that redirects the bodies own immune cells (T-cells) to attack and kill the lymphoma cells. The main question the trial aims to answer is if mosunetuzumab works better than standard treatments in this sub-group of patients. Patients will receive mosunetuzumab as injections in the abdominal subcutaneous fat once a week for the three first doses, then every third week 7 times. If all signs of disease are gone as evaluated by PET-CT images, the treatment is stopped. If signs of disease remain on PET-CT images, the patients can receive treatment every third week for up to a total of one year. After the end of treatment, patients are followed two years in the trial for signs of progression or relapse.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether mosunetuzumab — a bispecific antibody that helps your immune system recognize and destroy lymphoma cells — can effectively treat follicular lymphoma that came back or stopped responding within 24 months of initial treatment. This early relapse is considered a higher-risk situation. **You may be eligible if...** - You are 18 or older - You have follicular lymphoma (grade 1–3a) that has relapsed or progressed within 24 months of starting your first treatment, OR your lymphoma did not respond to first-line treatment - Your first treatment included a combination involving an anti-CD20 drug (like rituximab) and chemotherapy - You require further treatment based on your doctor's assessment **You may NOT be eligible if...** - Your follicular lymphoma has transformed into a more aggressive type - You have previously received CAR-T therapy - You have active serious infections or significant organ problems - You are pregnant or breastfeeding - You have other active cancers Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMosunetuzumab

Mosunetuzumab is administered as a subcutaneous injection. The first dose is 5 mg in 0,5 mL volume, subsequent doses are 45 mg in 1,0 mL volume.


Locations(3)

Helsinki University Hospital

Helsinki, Finland

Oslo University Hospital

Oslo, Norway

St. Olavs hospital

Trondheim, Norway

View Full Details on ClinicalTrials.gov

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NCT05849857


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