Actively Recruiting
Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries
Led by Oslo University Hospital · Updated on 2023-11-01
80
Participants Needed
3
Research Sites
255 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
H
Hoffmann-La Roche
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Age 18 years or older
- Diagnosed with follicular lymphoma grade 1-3a with relapse or progression within 24 months of starting first-line treatment containing a monospecific anti-CD20 antibody
- Lack of response or progression within 6 months following at least four cycles of anti-CD20 monotherapy or three cycles combined with other agents
- Received only one prior systemic therapy
- May have had watch and wait period before first-line treatment
- May have received localized radiotherapy
- At least one measurable lesion larger than 15 mm
- WHO performance status 0-2; patients with worse status may be considered if due to lymphoma
You will not qualify if you...
- Received two or more previous treatment lines
- Follicular lymphoma grade 3b
- CD20-negative lymphoma
- Central nervous system involvement
- Impaired bone marrow function unless due to lymphoma
- Severe cardiac disease (NYHA class III or IV, recent myocardial infarction, unstable arrhythmias or angina)
- Impaired liver function not caused by lymphoma
- Impaired kidney function with creatinine clearance ≤ 40 ml/min
- Other major organ dysfunction not caused by lymphoma
- History of drug-induced liver injury or chronic active hepatitis B or C
- Active severe infection
- Chronic active Epstein-Barr virus infection
- Recent use of systemic immunosuppressive medications
- Recent administration or planned use of live vaccines
- History of severe allergic reactions to antibodies or fusion proteins
- Known or suspected hemophagocytic syndrome
- Prior allogeneic hematopoietic stem cell transplant
- Severe medical problems or expected survival less than approximately five years for non-lymphoma reasons
- Other malignancy within three years except certain cured non-invasive cancers without approval
- Psychiatric disorders preventing informed consent or adherence
- Pregnancy or breastfeeding
- HIV positivity unless on treatment with undetectable viral load and sufficient CD4 count
- Women of reproductive potential not agreeing to use birth control during and for three months after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Helsinki University Hospital
Helsinki, Finland
Actively Recruiting
2
Oslo University Hospital
Oslo, Norway, 0424
Actively Recruiting
3
St. Olavs hospital
Trondheim, Norway
Actively Recruiting
Research Team
L
Louise Krüger Hansen
CONTACT
L
Lise Nylund Torpen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here