Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries

Sponsor
Oslo University Hospital
Study ID
NCT05849857
Phase
PHASE2
Status
Recruiting
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Conditions

  • Lymphoma, Follicular

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mosunetuzumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 11, 2023
Status verified
Oct 2023
Primary completion
Jun 30, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Subcutaneous mosunetuzumab
    The duration of each treatment cycle is 21 days. Cycle 1 Day 1: 5 mg Mosunetuzumab SC Cycle 1 Day 8: 45 mg Mosunetuzumab SC Cycle 1 Day 15: 45 mg Mosunetuzumab SC Cycle 2-8 Day 1: 45 mg Mosunetuzumab SC Patients in complete remission after 8 cycles enter follow-up. Patients with stable disease or partial remission can receive up to a total of 17 cycles: Cycle 9-17 Day 1: 45 mg Mosunetuzumab SC

Primary Outcome Measure

PFS [ Time Frame: From the date of starting treatment to the date of first documented progression of disease or death of any cause, whichever came first. Patients will be observed for a minimum of 2 years and a maximum of 4 years for the primary outcome ]

Central Contacts

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