Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries (MERLIN)
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ClinicalTrials.gov Identifier: NCT05849857 |
Recruitment Status :
Recruiting
First Posted : May 9, 2023
Last Update Posted : November 1, 2023
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Tracking Information | |||||||||
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First Submitted Date ICMJE | March 22, 2023 | ||||||||
First Posted Date ICMJE | May 9, 2023 | ||||||||
Last Update Posted Date | November 1, 2023 | ||||||||
Actual Study Start Date ICMJE | September 11, 2023 | ||||||||
Estimated Primary Completion Date | June 2027 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries | ||||||||
Official Title ICMJE | Phase II Multicenter Clinical Trial: Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries | ||||||||
Brief 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. | ||||||||
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
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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Phase II, one arm, open label clinical trial of subcutaneous mosunetuzumab mono-therapy Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Lymphoma, Follicular | ||||||||
Intervention ICMJE | Drug: Mosunetuzumab
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.
Other Name: Dexamethasone
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Study Arms ICMJE | 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 Intervention: Drug: Mosunetuzumab
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
80 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | August 2028 | ||||||||
Estimated Primary Completion Date | June 2027 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Finland, Norway | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT05849857 | ||||||||
Other Study ID Numbers ICMJE | EU CT NO: 2022-500100-21-01 NLG-FL6 ( Other Identifier: The Nordic Lymphoma Group ) ML43841 ( Other Identifier: Roche ) |
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Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Marianne Brodtkorb, Oslo University Hospital | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Oslo University Hospital | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Oslo University Hospital | ||||||||
Verification Date | October 2023 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |