Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries
ConditionLymphoma, Follicular
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOslo University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent according to ICH-GCP guidelines.
Age ≥ 18 years.
Documented current relapse or progression of FL within 24 months of starting first line treatment containing a monospecific anti-CD20 antibody (such as rituximab or obinutuzumab with or without chemotherapy, small molecular inhibitors or immunomodulating agents such as lenalidomide).
Current lack of response/refractoriness to first line treatment, i.e., no objective response or documented progression within 6 months following at least four cycles of monotherapy with a monospecific anti-CD20 antibody (such as rituximab 375mg/m2 iv or 1400 mg SC or equal) or following at least three cycles of a monospecific anti CD20 antibody combined with chemotherapy, small molecular inhibitors or immunomodulating agents such as lenalidomide.
Disqualifiers
Received 2 or more previous treatment lines.
Grade 3b FL.
CD20-negative lymphoma.
CNS involvement (current or previous).
Trial design
Design model
Single group
Treatments tested in this trial
Mosunetuzumab
DrugMosunetuzumab 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Subcutaneous mosunetuzumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PFS
Progression free survival
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 outcomeSecondary outcomes
1
ORR
Overall response rate assessed by PET-CT
Time frame
At the end of 8 cycles (each cycle is 21 days)2
CRR
Complete response rate assessed by PET-CT
Time frame
At the end of 8 cycles (each cycle is 21 days)3
DOR
Duration of response
Time frame
From the date of first documented response to the date of first documented disease progression or death from any cause. Patients will be observed for a minimum of 2.5 years and a maximum of 5 years for the DOR4
TTNT
Time to new lymphoma treatment
Time frame
From the date of starting study treatment to the date of starting 3rd line therapy due to progression of disease or to death of any cause, whichever came first. Patients will be observed for a minimum of 2.5 years and a maximum of 5 years for TTNT.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Oslo University Hospital
Lead sponsor
Hoffmann-La Roche
Collaborator
Aarhus University Hospital
Collaborator
Source ClinicalTrials.gov