Lymphoma, FollicularPhase 2MERLINNCT05849857
Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries
A Phase 2 study testing Mosunetuzumab in people with Lymphoma, Follicular, run by Oslo University Hospital at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Follicular
- What is being tested?
- Mosunetuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 11 Sep 2023to Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent according to ICH-GCP guidelines.
- Age ≥ 18 years.
- Follicular lymphoma grade 1-3a with a current relapse or progression within 24 months of starting 1st line treatment or refractory to 1st line treatment (POD24), more specifically:
- 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.
- Received one prior treatment line of systemic therapy.
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- Patients may have had a period of watch and wait before the initiation of first line treatment.
- Patients may have received localized radiotherapy previously.
- At least one two-dimensionally measurable lesion with a longest diameter >15mm.
- WHO performance status 0-2. Patients with reduced WHO performance status (> 2) can be considered if reduction in performance is caused by the lymphoma as determined by the investigator.
Who cannot join
- Received 2 or more previous treatment lines.
- Grade 3b FL.
- CD20-negative lymphoma.
- CNS involvement (current or previous).
- Impaired bone marrow function (neutrophils < 1.0 x 109/L or platelets < 50 x 109/L) unless due to lymphoma involvement.
- Severe cardiac disease: impaired cardiac function (NYHA class III or IV), myocardial infarction within the last 6 months, unstable arrythmias and/or unstable angina pectoris.
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- Impaired liver function not caused by lymphoma, defined as serum total bilirubin ≥ 1.5 x ULN (unless elevated due to Gilbert's syndrome) or serum ALT and AST > 3 x ULN.
- Impaired renal function not caused by lymphoma, defined as calculated creatinine clearance ≤ 40 ml/minute.
- Other major organ dysfunction not caused by lymphoma.
- Known history of drug induced liver injury, chronic active hepatitis C (HCV), chronic active hepatitis B (HBV), alcoholic liver disease, primary biliary cirrhosis, on-going extra-hepatic obstruction caused by cholelithiasis, cirrhosis of the liver or portal hypertension.
- Active severe infection.
- Hepatitis B (HBV) or hepatitis C (HCV) infection: Subjects with a previous hepatitis B infection will be eligible if they are negative for HBV-DNA; these subjects must be given prophylactic antiviral therapy. Subjects with a previous HCV infection will be eligible if they are negative for HCV-RNA.
- Known or suspected chronic active Epstein-Barr virus (EBV) infection.
- Received systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within two weeks prior to the first dose of mosunetuzumab.
- Administration of live vaccines within four weeks of the first dose of mosunetuzumab or anticipation that live vaccine will be required during the study.
- History of severe allergic or anaphylactic reactions to chimeric, human, or humanized antibodies, or fusion proteins.
- Known or suspected hemophagocytic syndrome.
- Prior allogeneic hematopoietic stem cell transplant.
- Other current severe medical problems or expected survival of less than approximately five years for non-lymphoma reasons.
- Current or previous other malignancy within three years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other non-invasive or indolent malignancy without sponsor approval.
- Psychiatric disorder or dementia which make the patient unable to give an informed consent and/or adhere to the schedule.
- Pregnancy or breast-feeding.
- HIV positivity: Subjects that are on HIV-treatment with undetectable HIV-RNA and CD4-counts above 200 will be eligible.
- Women of reproductive potential not agreeing to use an acceptable method of birth control during treatment and for three months after completion of treatment.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Norway2 sites, 2 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0424
Marianne Brodtkorb, MD, PhD, meide@ous-hf.no
Lise Nylund Torpen, Linyto@ous-hf.no
- Recruiting
St. Olavs hospital
Trondheim
Karin Wader, Md, PhD
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Hospital
Helsinki
Micalela Hernberg, MD, PhD
About this study
Official title: Phase II Multicenter Clinical Trial: Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries
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.
Read the detailed description
Background: Standard first line treatment for patients with follicular lymphoma and symptomatic disease is immunotherapy with or without chemotherapy. The most commonly used treatment regimens are rituximab plus bendamustin or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone), rituximab plus lenalidomide or rituximab monotherapy. The long-term outcome is similar for these regimens; 75-80% of patients are alive 10 years after initial treatment. A subgroup of 20-40% of patients does not respond to or relapse within 24 months of initial treatment (abbreviated POD24 for "progression of disease within 24 months), and they risk poorer effect of second line treatments and shorter survival. Only 30-70% of these patients are alive 5 years after initial treatment, depending on the type of first line treatment, and they are in need of improved treatment options. Mosunetuzumab is a new, bispecific, T-cell engaging antibody that has shown very high response rates and long response duration in B-cell lymphoma patients with multiple relapses or lack of response to standard salvage regimens. It is therefore possible that mosunetuzumab will benefit patients with POD24. The main hypothesis of this trial is that mosunetuzumab is better than standard 2nd line salvage regimens in terms of progression free survival 2 years after the initiation of 2nd line treatment in POD24 patients.
Objectives: The main objective is to investigate the efficacy of subcutaneous (SC) mosunetuzumab monotherapy in follicular lymphoma (FL) with POD24.
The secondary objectives are to investigate
- safety of mosunetuzumab in patients with a current POD24 event
- prognostic significance of 18F-FDG-PET-CT response to mosunetuzumab
- rate of transformation to higher grade lymphoma following mosunetuzumab
- patients´ self-reported quality of life during and after mosunetuzumab
- resource usage related to mosunetuzumab
Interventions: Mosunetuzumab is administered SC as described below. Patients are followed for at least 2,5 years and a maximum of 5 years in the trial. Study-specific sampling of peripheral blood for exploratory research amounts to 330-380 mL (depending on the number of treatment cycles) collected over 3 years. Study-specific tumor samples for future research will be collected by fine needle aspiration before the start of treatment and after the third treatment cycle.
Ethical considerations: Previous studies have shown that mosunetuzumab is highly effective and well tolerated in heavily treated B-cell lymphoma patients. The safety profile is favourable compared to standard immunochemotherapy. Mosunetuzumab can be safely administered to older patients with co-morbidities, and there is no upper age limit for participation in the trial. The potential beneficial effect of mosunetuzumab in a population of follicular lymphoma patients with POD24 outweighs the risk for rare and undiscovered serious adverse events. The total volume of blood samples is considered acceptable for patients in clinical trials. The extra tumor samples for research purposes will only be collected if deemed safe and not to cause unreasonable discomfort for the participating subject. The extra number of CT scans is 2-3 compared to standard practice and represents a minimal increase in radiation exposure. In total, the benefit to risk balance is deemed positive for this trial.
- Conditions
- Lymphoma, Follicular
- Being tested
- Mosunetuzumab
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MosunetuzumabDrug
Also called Dexamethasone
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 group | Role | What they receive |
|---|---|---|
| Subcutaneous mosunetuzumab | Experimental | 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 Receives: Drug: Mosunetuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression free survival
Measured: 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
Secondary outcomes (7)
ORR
Overall response rate assessed by PET-CT
Measured: At the end of 8 cycles (each cycle is 21 days)
CRR
Complete response rate assessed by PET-CT
Measured: At the end of 8 cycles (each cycle is 21 days)
DOR
Duration of response
Measured: 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 DOR
TTNT
Time to new lymphoma treatment
Measured: 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.
OS
Overall survival
Measured: From the date of inclusion to the date of death of any cause. Patients will be observed for a minimum of 2.5 years and a maximum of 5 years for OS.
The percentage of patients with adverse events
Safety and tolerability
Measured: From inclusion until 30 days after last dose of study drug
The percentage of patients with transformation to aggressive lymphoma
The rate of higher grade lymphoma transformation
Measured: From inclusion to the end of follow-up. Patients will be observed for a minimum of 2.5 years and a maximum fo 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start11 Sep 2023
- Primary completionJun 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, FollicularStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase II, one arm, open label clinical trial of subcutaneous mosunetuzumab mono-therapy
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche, Aarhus University Hospital
- Responsible party
- Principal investigator, Marianne Brodtkorb, Oslo University Hospital
- Investigators
- Marianne Brodtkorb, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849857
- Sponsor's protocol ID
- EU CT NO: 2022-500100-21-01
- Other IDs
- NLG-FL6, ML43841
- Acronym
- MERLIN
- Status last verified
- Oct 2023
- First submitted
- 22 Mar 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participation data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter Clinical Trial: Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries
- ClinicalTrials.gov ID
- NCT05849857
- Acronym / sponsor ID
- MERLIN / EU CT NO: 2022-500100-21-01
- Conditions
- Lymphoma, Follicular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche, Aarhus University Hospital
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Standard first line treatment for patients with follicular lymphoma and symptomatic disease is immunotherapy with or without chemotherapy. The most commonly used treatment regimens are rituximab plus bendamustin or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone), rituximab plus lenalidomide or rituximab monotherapy. The long-term outcome is similar for these regimens; 75-80% of patients are alive 10 years after initial treatment. A subgroup of 20-40% of patients does not respond to or relapse within 24 months of initial treatment (abbreviated POD24 for "progression of disease within 24 months), and they risk poorer effect of second line treatments and shorter survival. Only 30-70% of these patients are alive 5 years after initial treatment, depending on the type of first line treatment, and they are in need of improved treatment options. Mosunetuzumab is a new, bispecific, T-cell engaging antibody that has shown very high response rates and long response duration in B-cell lymphoma patients with multiple relapses or lack of response to standard salvage regimens. It is therefore possible that mosunetuzumab will benefit patients with POD24. The main hypothesis of this trial is that mosunetuzumab is better than standard 2nd line salvage regimens in terms of progression free survival 2 years after the initiation of 2nd line treatment in POD24 patients.
Objectives: The main objective is to investigate the efficacy of subcutaneous (SC) mosunetuzumab monotherapy in follicular lymphoma (FL) with POD24.
The secondary objectives are to investigate
- safety of mosunetuzumab in patients with a current POD24 event
- prognostic significance of 18F-FDG-PET-CT response to mosunetuzumab
- rate of transformation to higher grade lymphoma following mosunetuzumab
- patients´ self-reported quality of life during and after mosunetuzumab
- resource usage related to mosunetuzumab
Interventions: Mosunetuzumab is administered SC as described below. Patients are followed for at least 2,5 years and a maximum of 5 years in the trial. Study-specific sampling of peripheral blood for exploratory research amounts to 330-380 mL (depending on the number of treatment cycles) collected over 3 years. Study-specific tumor samples for future research will be collected by fine needle aspiration before the start of treatment and after the third treatment cycle.
Ethical considerations: Previous studies have shown that mosunetuzumab is highly effective and well tolerated in heavily treated B-cell lymphoma patients. The safety profile is favourable compared to standard immunochemotherapy. Mosunetuzumab can be safely administered to older patients with co-morbidities, and there is no upper age limit for participation in the trial. The potential beneficial effect of mosunetuzumab in a population of follicular lymphoma patients with POD24 outweighs the risk for rare and undiscovered serious adverse events. The total volume of blood samples is considered acceptable for patients in clinical trials. The extra tumor samples for research purposes will only be collected if deemed safe and not to cause unreasonable discomfort for the participating subject. The extra number of CT scans is 2-3 compared to standard practice and represents a minimal increase in radiation exposure. In total, the benefit to risk balance is deemed positive for this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase II, one arm, open label clinical trial of subcutaneous mosunetuzumab mono-therapy
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous mosunetuzumab | Experimental | Drug: MosunetuzumabThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent according to ICH-GCP guidelines.
- Age ≥ 18 years.
- Follicular lymphoma grade 1-3a with a current relapse or progression within 24 months of starting 1st line treatment or refractory to 1st line treatment (POD24), more specifically:
- At least one two-dimensionally measurable lesion with a longest diameter >15mm.
- WHO performance status 0-2. Patients with reduced WHO performance status (> 2) can be considered if reduction in performance is caused by the lymphoma as determined by the investigator.
Key exclusion criteria (24 listed)
- Received 2 or more previous treatment lines.
- Grade 3b FL.
- CD20-negative lymphoma.
- CNS involvement (current or previous).
- Impaired bone marrow function (neutrophils < 1.0 x 109/L or platelets < 50 x 109/L) unless due to lymphoma involvement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MosunetuzumabAlso: DexamethasoneMosunetuzumab 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. | Drug | Subcutaneous mosunetuzumab |
Primary outcome
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
Progression free survival
7 secondary outcomes
ORR
Time frame: At the end of 8 cycles (each cycle is 21 days)
CRR
Time frame: At the end of 8 cycles (each cycle is 21 days)
DOR
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 DOR
TTNT
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.
OS
Time frame: From the date of inclusion to the date of death of any cause. Patients will be observed for a minimum of 2.5 years and a maximum of 5 years for OS.
The percentage of patients with adverse events
Time frame: From inclusion until 30 days after last dose of study drug
The percentage of patients with transformation to aggressive lymphoma
Time frame: From inclusion to the end of follow-up. Patients will be observed for a minimum of 2.5 years and a maximum fo 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No. Individual participation data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marianne Brodtkorb, MD, PhD principal investigator
Oslo University Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mosunetuzumab in people with Lymphoma, Follicular, run by Oslo University Hospital at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louise Krüger Hansen (+45 24782645, louise.kruger.hansen@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.