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New treatment option for Lymphoma, Follicular
Official title Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries
ClinicalTrials.gov ID: NCT05849857
What this study is testing
What is Mosunetuzumab?
Mosunetuzumab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for lymphoma, follicular.
Also referred to as Dexamethasone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Documented current relapse or progression of FL within 24 months of starting first line treatment containing a monospecific anti-CD20 antibody (such...
- Current lack of response/refractoriness to first line treatment, i.e., no objective response or documented progression within 6 months following at...
You likely can't join if
- 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...
See the full eligibility criteria
- 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...
- 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...
- Received one prior treatment line of systemic therapy.
- 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.
- 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.
- 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...
- Active severe infection.
- Hepatitis B (HBV) or hepatitis C (HCV) infection: people with a previous hepatitis B infection will be eligible if they are negative for HBV-DNA; these people must be given prophylactic antiviral therapy. people with a...
- 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...
- 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...
- 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: people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Helsinki, Finland
- Oslo, Norway
- Trondheim, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Helsinki, Finland; Oslo, Norway; Trondheim, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.