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Compares treatment options for Follicular Lymphoma
Official title Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5
ClinicalTrials.gov ID: NCT06284122
What this study is testing
What is Mosunetuzumab?
Mosunetuzumab is an investigational medicine, being studied as a potential treatment for follicular lymphoma.
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
- This study is a phase III, randomized, open-label, international, multicenter, interventional trial, designed to compare the efficacy and safety of mosunetuzumab in combination with lenalidomide versus anti-CD20 monoclonal antibody (mAb) plus chemotherapy in patients with previously untreated FLIPI 2-5 follicular lymphoma.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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
- 1\. Patient with histologically proven previously untreated CD20+ follicular lymphoma grade 1, 2, or 3a (including patient watched during up to 10...
- FLIPI 2-5.
- All Ann Arbor stages (including stage I if FLIPI ≥ 2).
- Must need treatment as evidenced by at least one of the following criteria: 4.1. Bulky disease defined as one of the following: 4.1.1. a nodal or...
- At least one bi-dimensionally measurable nodal lesion, defined as \> 15 mm in its longest dimension, or at least one bi-dimensionally measurable...
You likely can't join if
- Grade 3b follicular lymphoma according to the WHO 2016 classification12, or follicular large B-cell lymphoma according to the WHO 2022...
- Suspicion or clinical evidence of transformed lymphoma at enrollment by investigator assessment. Examples: patients with high or intermediate high...
- Prior localized radiotherapy for the FL.
- Prior history of another lymphoma.
- Uncontrolled symptomatic pleural or serous effusion requiring urgent treatment (within one week of finding). Participants may only be enrolled after...
- Uncontrolled symptomatic ureterohydronephrosis resulting in renal failure. Participants with adequate management i.e. ureteral catheter or double J...
See the full eligibility criteria
Who can join
- 1\. Patient with histologically proven previously untreated CD20+ follicular lymphoma grade 1, 2, or 3a (including patient watched during up to 10 years after initial diagnosis) as assessed by the investigators...
- FLIPI 2-5.
- All Ann Arbor stages (including stage I if FLIPI ≥ 2).
- Must need treatment as evidenced by at least one of the following criteria: 4.1. Bulky disease defined as one of the following: 4.1.1. a nodal or extranodal mass/lesion \> 70 mm in its largest diameter or, 4.1.2...
- At least one bi-dimensionally measurable nodal lesion, defined as \> 15 mm in its longest dimension, or at least one bi-dimensionally measurable extra nodal lesion, defined as \> 10 mm in its longest dimension (and...
- Participant who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures.
- Must be ≥ 18 years old at the time of signing the informed consent form (ICF).
- ECOG performance status 0 to 2.
- Estimated minimum life expectancy of 3 months.
- Adequate hematological function within 28 days prior to randomization, including: 10.1. Absolute neutrophil count (ANC) ≥ 1 x 109/L 10.2. Platelet count ≥ 75 x 109/L, or ≥ 30 x 109/L if bone marrow infiltration or...
- Normal laboratory values: 11.1. Measured or estimated creatinine clearance ≥ 40mL/min calculated by institutional standard method (MDRD or Cockcroft-Gault 11.2. AST or ALT ≤ 2.5 x the upper limit of normal (ULN), except...
- LVEF within normal range (i.e. \> 50% as evaluated by Transthoracic Echocardiography or \> 45% as evaluated by isotopic method (MUGA scan).
- Participants should be able to receive adequate prophylaxis and/or therapy for thromboembolic events (aspirin, low molecular weight heparin or direct oral anticoagulants). Patients with a curative anticoagulation...
- Must be able to adhere to the study visit schedule and other protocol requirements.
- No more applicable following SM#14
- Negative HIV test before randomization, with the following exception: Patients with a positive HIV test before randomization are eligible provided they are stable on antiretroviral therapy for at least 4 weeks, have a...
- For women of childbearing potential (WOCBP) :
- must have a negative result for pregnancy test (highly sensitive serum) within 7 days before randomization and within 7 days before initiation of study treatment.
- must agree to abstain from becoming pregnant or breastfeeding, and agree to use highly effective contraceptive methods during study participation, and for at least 28 days after the final dose of lenalidomide (if...
- For men with a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period (including periods of treatment interruption), and for at least...
- Participant covered by any social security system (France).
- Participant who understands and speaks one of the country official languages, unless local regulation authorizes independent translators.
What rules you out
- Grade 3b follicular lymphoma according to the WHO 2016 classification12, or follicular large B-cell lymphoma according to the WHO 2022 classification13
- Suspicion or clinical evidence of transformed lymphoma at enrollment by investigator assessment. Examples: patients with high or intermediate high SUV (\>20) in any nodal or extranodal site particularly in the bones...
- Prior localized radiotherapy for the FL.
- Prior history of another lymphoma.
- Uncontrolled symptomatic pleural or serous effusion requiring urgent treatment (within one week of finding). Participants may only be enrolled after Coordinating investigator / sponsor approval once confirmed...
- Uncontrolled symptomatic ureterohydronephrosis resulting in renal failure. Participants with adequate management i.e. ureteral catheter or double J stent allowing renal failure control are eligible only if urinary...
- Presence or history of symptomatic or threatening lymphomatous epidural/nerve root lesion, even such participants whose disease is controlled by short course of steroids are NOT eligible.
- Use of any standard or experimental anti-cancer drug therapy within 45 days of the start (Day 1) of study treatment.
- Any contraindication to any drug contained in the study treatment control arms or in the Auxiliary Medicinal Products (AxMPs)
- Systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) and corticosteroids on the long run with the...
- Received a live, attenuated vaccine within 4 weeks before the first dose of study treatment, or in whom it is anticipated that such a live attenuated vaccine will be required during the study period or within 6 months...
- Major surgery (excluding surgical documentation of FL) within 28 days prior to signing informed consent.
- Seropositive for or active viral infection with hepatitis B virus (HBV):
- HBsAg positive
- HBsAg negative, anti-HBs positive and/or anti-HBc positive and detectable viral DNA (Patients who are HBsAg negative, anti-HBs positive and/or anti-HBc positive but viral DNA negative are eligible. They should be...
- Known seropositive for, or active infection hepatitis C virus (HCV) (Patients who are positive for HCV antibody with a negative viral RNA are eligible).
- Known or suspected hypersensitivity to biopharmaceuticals produced in CHO cells or any component of the mosunetuzumab, anti-CD20 mAb, tocilizumab, lenalidomide formulation, including mannitol; or to any of the...
- History of solid organ transplantation or allogeneic stem cell transplant (SCT).
- Active autoimmune disease requiring treatment.
- History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis...
- Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.
- Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
- Participants with a remote history of, or well-controlled autoimmune disease, with a treatment-free interval from immunosuppressive therapy for 12 months may be eligible after review and discussion with the Coordinating...
- Participants with any active infection such as known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds), known or suspected...
- Evidence of any significant, concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to:
- significant cardiovascular disease [e.g., Objective Class C or D heart diseases (cf. Classes of Heart Failure \| American Heart Association), myocardial infarction within the previous 6 months, unstable arrhythmia, or...
- significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)
- clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis
- current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Participants with a history of stroke who have not experienced a stroke or...
- History of confirmed progressive multifocal leukoencephalopathy (PML).
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).
- History of erythema multiforme, Grade ≥3 rash, or blistering rash following prior treatment with immunomodulatory derivatives.
- History of interstitial lung disease (ILD), drug-induced pneumonitis, and autoimmune pneumonitis.
- Active malignancy other than the one treated in this research. Prior history of malignancies unless the patient has been free of the disease and therapy for ≥ 3 years. However, patients with a single occurrence of the...
- Localized non-melanoma skin cancer.
- Carcinoma in situ of the cervix.
- Carcinoma in situ of the breast.
- Incidental histologic finding of prostate cancer (T1a or T1b as per Tumor Node Metastasis [TNM] staging system) or prostate cancer.
- Presence or history of CNS or meningeal involvement by lymphoma.
- Pregnant, planning to become pregnant or lactating WOCBP.
- Any significant medical conditions, including the presence of laboratory abnormality or psychiatric illness which places the patient at unacceptable risk if he/she were to participate in the study, and likely to...
- Person deprived of his/her liberty by a judicial or administrative decision.
- Person hospitalized without consent.
- Adult person under legal protection.
- Patients with absolute lymphocyte count \> 20 G/L before randomization. Participants circulating lymphoma cell≥ 5 G/L must be discussed with the Sponsor before randomization. NB: for 29-31., if there is an individual...
The study team makes the final eligibility decision.
Where it's taking place
- Graz, Austria
- Krems, Austria
- Leoben, Austria
- Linz, Austria
- Salzburg, Austria
- Sankt Pölten, Austria
- Vienna, Austria
- Wels, Austria
- Wiener Neustadt, Austria
- Bruges, Belgium
- Brussels, Belgium
- Charleroi, Belgium
- Ghent, Belgium
- La Louvière, Belgium
- Liège, Belgium
- Yvoir, Belgium
- Avignon, France
- Bayonne, France
- Besançon, France
- Bordeaux, France
+ 83 more site(s).
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Graz, Austria; Krems, Austria; Leoben, Austria; Linz, Austria; Salzburg, Austria; Sankt Pölten, Austria and 97 more location(s). 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.