Phase
Condition
Lymphoma
Follicular Lymphoma
Lymphoproliferative Disorders
Treatment
Prednisone
Rituximab
Mosunetuzumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient with histologically proven previously untreated CD20+ follicular lymphomagrade 1, 2, or 3a (including patient watched during up to 10 years after initialdiagnosis) as assessed by the investigators according to the World HealthOrganization (WHO) 2016 classification12, or classical follicular lymphoma accordingto the WHO 2022 classification13. Diagnostic tissue must be available for centralpathology review, exploratory endpoints and secondary data use. (Patients withabsolute lymphocyte count > 20 G/L must be discussed with the Sponsor beforescreening/inclusion).
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:
Bulky disease defined as:
a nodal or extranodal mass/lesion > 7 cm in its largest diameter or,
involvement of at least 3 nodal or extranodal sites (each with a diametergreater than > 3 cm)
Presence of at least one of the following B symptoms:
fever (> 38°C) of unclear etiology
night sweats
weight loss greater than 10% within the prior 6 months
Symptomatic splenomegaly
Any compressive syndrome (for example, but not restricted to- ureteral,orbital, gastrointestinal)
Any one of the following cytopenias due to lymphoma:
hemoglobin < 10g/dL (6.25 mmol/L)
platelets <100 x 109/L, or
absolute neutrophil count (ANC) < 1.5 x 109/L
Pleural or peritoneal serous effusion (irrespective of cell content)
β2microglobulin > ULN or lactate dehydrogenase (LDH) > ULN
At least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in itslongest dimension, or at least one bi-dimensionally measurable extra nodal lesion,defined as > 1.0 cm in its longest dimension (and 18F-2-fluoro-2-deoxy-D-glucose (FDG)-avid lesion).
Patient who understood and voluntarily signed and dated an informed consent prior toany study-specific assessments/procedures.
Must be ≥ 18 years at the time of signing the informed consent form (ICF).
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Estimated minimum life expectancy of 3 months.
Adequate hematological function within 28 days prior to signing informed consent,including:
Absolute neutrophil count (ANC) ≥ 1 x 109/L
Platelet count ≥ 75 x 109/L, or ≥ 30 x 109/L if bone marrow infiltration orsplenomegaly
Hemoglobin ≥ 8.0 g/dL (5 mmol/L) unless related to bone marrow infiltration orsplenomegaly. Transfusion is allowed before starting treatment (no requiredwindow)
- Normal laboratory values:
Measured or estimated creatinine clearance ≥ 40 mL/min calculated byinstitutional standard method (MDRD or Cockcroft-Gault)
aspartate aminotransferase (AST) or alanine aminotransférase (ALT) ≤ 2.5 x theupper limit of normal (ULN), except in patients with documented liver orpancreatic involvement by lymphoma ≤ 5 x ULN
Serum total bilirubin ≤ 1.5 x ULN (or ≤ 3 x ULN for patients with Gilbertsyndrome), except in patients with documented liver or pancreatic involvementby lymphoma ≤ 3 x ULN
left ventricular ejection fraction (LVEF) within normal range (i.e. > 50% asevaluated by Transthoracic Echocardiography or > 45% as evaluated by isotopic method (MUGA scan)).
Patients should be able to receive adequate prophylaxis and/or therapy forthromboembolic events (aspirin, low molecular weight heparin or direct oralanticoagulants). Patients with a curative anticoagulation therapy can be enrolled. A patient withdeep vein thrombosis due to compressive syndrome is eligible if a curativeanticoagulation therapy has been started at least 1 week before initiating studytreatment: low molecular weight heparin possible at treatment onset, then directoral anticoagulants according to local practices.
Must be able to adhere to the study visit schedule and other protocol requirements.
Negative SARS-CoV-2 test within 7 days prior to randomization. Rapid antigen test isalso acceptable. If a patient has a positive SARS-CoV-2 test before randomization,another test should be done and be negative within 7 days before initiation oftreatment.
Negative HIV test before randomization, with the following exception: Patients with a positive HIV test before randomization are eligible provided theyare stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥ 200/ µL, have an undetectable viral load, and have not had a history of opportunisticinfection attributable to AIDS within the last 12 months.
For women of childbearing potential (WOCBP) (refer to section 14.7): must have anegative result for pregnancy test (highly sensitive serum) at screening and within 7 days before initiation of study treatment, and agree to abstain from breastfeedingduring study participation, and for at least 28 days after the final dose oflenalidomide (if applicable), 3 months after the final dose of mosunetuzumab andtocilizumab (if applicable), 6 months after the final dose of chemotherapies (ifapplicable), 12 months after the final dose of rituximab (if applicable), and 18months after the final dose of obinutuzumab (if applicable).
For men (refer to section 14.7): Agreement to remain abstinent (refrain fromheterosexual intercourse) or use a condom, and agreement to refrain from donatingsperm, as defined below: with a female partner of childbearing potential or pregnantfemale partner, men must remain abstinent or use a condom during the treatmentperiod (including periods of treatment interruption), and for at least 28 days afterthe final dose of lenalidomide (if applicable), 2 months after the final dose oftocilizumab (if applicable), 6 months after the final dose of chemotherapies (ifapplicable), 12 months after the final dose of rituximab (if applicable), and 3months after the final dose of obinutuzumab (if applicable).
Patient covered by any social security system (France).
Patient who understands and speaks one of the country official languages, unlesslocal regulation authorizes independent translators.
Exclusion
Exclusion Criteria:
Grade 3b follicular lymphoma according to the WHO 2016 classification12, orfollicular large B-cell lymphoma according to the WHO 2022 classification13.
Suspicion or clinical evidence of transformed lymphoma at enrollment by investigatorassessment (e.g., high SUV in at least one lesion that was not biopsied, anddiscordant with SUV of biopsied lesion (at least double of the average SUV), LDH > 2.5 x ULN especially in a context of rapidly progressive disease, etc. (Pleasecontact the Sponsor to discuss any possible inclusion in borderline cases or anydoubt)
Prior localized radiotherapy for the FL.
Prior history of another lymphoma.
Uncontrolled symptomatic pleural or serous effusion requiring urgent treatmentwithin 48 hours (patients with controlled disease after adequate pleural/serousdrainage and/or effective pleurX™ or similar system are eligible).
Uncontrolled symptomatic ureterohydronephrosis resulting in renal failure (patientswith adequate management i.e. ureteral catheter or double J stent allowing renalfailure control are eligible).
Symptomatic lymphomatous epidural lesion (patients whose disease is controlled byneurosurgery or short course of steroids are eligible).
Use of any standard or experimental anti-cancer drug therapy within 42 days of thestart (Day 1) of study treatment.
Systemic immunosuppressive medications (including, but not limited to,cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosisfactor agents) or corticosteroid > 1mg/kg/day prednisone or equivalent within 10days prior to first dose of study treatment. Systemic corticosteroid treatment < 20mg/day of prednisone or equivalent, inhaled corticosteroids and mineralocorticoidsfor management of orthostatic hypotension is permitted. A single dose ofdexamethasone for nausea or B symptoms is permitted.
Received a live, attenuated vaccine within 4 weeks before the first dose of studytreatment, or in whom it is anticipated that such a live attenuated vaccine will berequired during the study period or within 5 months after the final dose of studytreatment.
Major surgery (excluding surgical documentation of FL) within 28 days prior tosigning 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 viralDNA (Patients who are HBsAg negative, anti-HBs positive and/or anti-HBcpositive but viral DNA negative are eligible. They should be treated andperform testing at regular interval; Patients who are seropositive due to ahistory of hepatitis B vaccine (anti-HBs positive) are eligible).
Known seropositive for, or active infection hepatitis C virus (HCV) (Patients whoare positive for HCV antibody with a negative viral RNA are eligible).
Known or suspected hypersensitivity to biopharmaceuticals produced in Chinesehamster ovarian (CHO) cells or any component of the mosunetuzumab, Anti-CD20 mAb,tocilizumab, lenalidomide formulation, including mannitol; or to any of theexcipients.
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 associated with antiphospholipidsyndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome,multiple sclerosis, vasculitis, or glomerulonephritis
Participants with a history of autoimmune-related hypothyroidism on a stabledose of thyroid replacement hormone may be eligible.
Participants with controlled Type 1 diabetes mellitus who are on an insulinregimen are eligible for the study.
Participants with a history of disease-related immune thrombocytopenic purpuraor autoimmune hemolytic anemia may be eligible.
Participants with a remote history of, or well-controlled autoimmune disease,with a treatment-free interval from immunosuppressive therapy for 12 months maybe eligible after review and discussion with the Primary investigator.
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 chronic activeEpstein-Barr virus (EBV) infection, are excluded.
Evidence of any significant, concomitant disease that could affect compliance withthe 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), myocardialinfarction within the previous 6 months, unstable arrhythmia, or unstableangina)
significant pulmonary disease (such as obstructive pulmonary disease or historyof bronchospasm)
clinically significant history of liver disease, including viral or otherhepatitis, or cirrhosis
current or past history of central nervous system (CNS) disease, such asstroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Participantswith a history of stroke who have not experienced a stroke or transientischemic attack in the past 1 year and have no residual neurologic deficits asjudged by the investigator are allowed. Participants with a history of epilepsywho have had no seizures in the past 2 years with or without anti-epilepticmedications can be eligible.
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 priortreatment with immunomodulatory derivatives.
History of interstitial lung disease (ILD), drug-induced pneumonitis, and autoimmunepneumonitis.
Active malignancy other than the one treated in this research. Prior history ofmalignancies unless the patient has been free of the disease for ≥ 3 years. However,patients with the following history/concurrent conditions are eligible:
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 NodeMetastasis (TNM) staging system) or prostate cancer that has been treated withcurative intent.
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 abnormalityor psychiatric illness which places the patient at unacceptable risk if he/she wereto participate in the study, and likely to interfere with participation in thisclinical study (according to the investigator's decision) or which confounds theability to interpret data from the study.
Person deprived of his/her liberty by a judicial or administrative decision.
Person hospitalized without consent.
Adult person under legal protection.
Nota bene: for 28., if there is an individual benefit for such patients, an Ethics Committee will have to be informed case by case.
Study Design
Study Description
Connect with a study center
AZ SINT-JAN BRUGGE - OOSTENDE AV - Service Hématologie
Brugge, 8000
BelgiumActive - Recruiting
INSTITUT JULES BORDET - Service Hématologie
Bruxelles, 1070
BelgiumActive - Recruiting
UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Service Hématologie
Bruxelles, 1200
BelgiumActive - Recruiting
GRAND HOPITAL DE CHARLEROI - Service Hématologie
Charleroi, 6000
BelgiumActive - Recruiting
UNIVERSITAIR ZIEKENHUIS GENT - Service Hématologie
Gent, 9000
BelgiumActive - Recruiting
CHU DE LIEGE - Service Hématologie
Liège, 4000
BelgiumActive - Recruiting
CHR VERVIERS - LA TOURELLE - Service Hématologie
Verviers, 4800
BelgiumActive - Recruiting
CHU UCL NAMUR - SITE GODINNE - Service Hématologie
Yvoir, 5530
BelgiumActive - Recruiting
CH d'AVIGNON - HOPITAL HENRI DUFFAUT - Service d'Onco-Hématologie
Avignon, 84000
FranceActive - Recruiting
CH DE LA COTE BASQUE - Service Hématologie
Bayonne, 64100
FranceActive - Recruiting
CHU JEAN MINJOZ - Service Hématologie
Besançon, 25030
FranceActive - Recruiting
INSTITUT BERGONIE - Service d'Oncologie Médicale
Bordeaux, 33076
FranceActive - Recruiting
CENTRE HOSPITALIER JEAN ROUGIER - Service d'Oncologie - Hématologie
Cahors, 46005
FranceActive - Recruiting
CH METROPOLE SAVOIE - SITE CHAMBERY - Service Hématologie
Chambéry, 73011
FranceActive - Recruiting
CHU ESTAING - Service Thérapie Cellulaire et Hématologie Clinique
Clermont-Ferrand, 63003
FranceActive - Recruiting
HOPITAL HENRI MONDOR - Unité Hémopathies Lymphoïdes
Créteil, 94010
FranceActive - Recruiting
CHU DIJON BOURGOGNE - Service Hématologie Clinique
Dijon, 21000
FranceActive - Recruiting
CHD DE VENDEE - Service Hématologie
La Roche-sur-Yon, 85925
FranceActive - Recruiting
CHU DE GRENOBLE - Service Hématologie
La Tronche, 38700
FranceActive - Recruiting
CHRU DE LILLE - HOPITAL CLAUDE HURIEZ - Service Hématologie
Lille, 59037
FranceActive - Recruiting
HOPITAL SAINT VINCENT-DE-PAUL - Service Hématologie
Lille, 59020
FranceActive - Recruiting
CHU DE LIMOGES - HOPITAL DUPUYTREN - Service Hématologie Clinique et Thérapie Cellulaire
Limoges, 87042
FranceActive - Recruiting
INSTITUT PAOLI CALMETTES - Service Hématologie
Marseille, 13273
FranceActive - Recruiting
CHU DE MONTPELLIER - Département d'Hématologie Clinique
Montpellier, 34090
FranceActive - Recruiting
GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER - Service Hématologie
Mulhouse, 68100
FranceActive - Recruiting
CHU DE NANTES - Service Hématologie
Nantes, 44093
FranceActive - Recruiting
CENTRE HOSPITALIER DE NIORT - Médecine interne
Niort, 79021
FranceActive - Recruiting
HOPITAL SAINT-LOUIS - Service Hématologie
Paris, 75475
FranceActive - Recruiting
CHU DE BORDEAUX - HOPITAL HAUT-LEVEQUE - CENTRE FRANCOIS MAGENDIE - Service d'Hématologie et Thérapie Cellulaire
Pessac, 33604
FranceActive - Recruiting
CHU LYON-SUD - Hématologie
Pierre-Bénite, 69495
FranceActive - Recruiting
CHI POISSY SAINT-GERMAIN-EN-LAYE - Service Hématologie
Poissy, 78303
FranceActive - Recruiting
CHU DE POITIERS - HOPITAL DE LA MILETRIE - Service d'Oncologie Hématologique et Thérapie Cellulaire
Poitiers, 86021
FranceActive - Recruiting
CH ANNECY GENEVOIS - SITE D'ANNECY - Service Hématologie
Pringy, 74374
FranceActive - Recruiting
CHU DE REIMS - HOPITAL ROBERT DEBRE - Service Hématologie
Reims, 57092
FranceActive - Recruiting
CHU PONTCHAILLOU - Hématologie Clinique
Rennes, 35033
FranceActive - Recruiting
CENTRE HENRI BECQUEREL - Service Hématologie
Rouen, 76038
FranceActive - Recruiting
INSTITUT CURIE - SITE SAINT-CLOUD - Service Hématologie
Saint-Cloud, 92210
FranceActive - Recruiting
Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne - Service Hématologie
Saint-Priest-en-Jarez, 42270
FranceActive - Recruiting
INSTITUT DE CANCEROLOGIE STRASBOURG EUROPE - Unité de Recherche Clinique
Strasbourg, 67033
FranceActive - Recruiting
IUCT ONCOPOLE - Service Hématologie
Toulouse, 31059
FranceActive - Recruiting
CHU BRETONNEAU - Service Cancérologie - Hématologie et Thérapie Cellulaire
Tours, 37044
FranceActive - Recruiting
CH DE VALENCIENNES - HOPITAL JEAN BERNARD - Service Hématologie
Valenciennes, 59322
FranceActive - Recruiting
CHU BRABOIS - Service Hématologie
Vandœuvre-lès-Nancy, 54511
FranceActive - Recruiting
CH DE BRETAGNE ATLANTIQUE - HOPITAL CHUBERT - Service Hématologie
Vannes, 56017
FranceActive - Recruiting
GUSTAVE ROUSSY CANCER CAMPUS GRAND PARIS - Département Médecine Oncologique
Villejuif, 94085
FranceActive - Recruiting
UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III
Regensburg, 93053
GermanyActive - Recruiting
UNIV KLINIKUM ULM - INNERE MEDIZIN III - Service Hématologie
Ulm, 89081
GermanyActive - Recruiting
INSTITUTO PORTUGUES DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL - Departamento Hematologia
Lisboa, 1099
PortugalActive - Recruiting
HOSPITAL CLINICO SALAMANCA - Servicio de Hematologia
Salamanca, 37007
SpainActive - Recruiting
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