Actively Recruiting
Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5
Led by The Lymphoma Academic Research Organisation · Updated on 2024-10-15
790
Participants Needed
49
Research Sites
512 weeks
Total Duration
On this page
Sponsors
T
The Lymphoma Academic Research Organisation
Lead Sponsor
L
Lymphoma Study Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed previously untreated CD20+ follicular lymphoma grade 1, 2, or 3a
- FLIPI score between 2 and 5
- Any Ann Arbor stage including stage I if FLIPI 46 2
- Requires treatment based on bulky disease, B symptoms, symptomatic splenomegaly, compressive syndrome, cytopenias, serous effusion, or elevated beta-2 microglobulin or LDH
- At least one measurable nodal lesion >1.5 cm or extranodal lesion >1.0 cm with FDG uptake
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Estimated life expectancy of at least 3 months
- Adequate blood counts and normal laboratory values within 28 days prior to consent
- Left ventricular ejection fraction within normal range
- Able to receive prophylaxis or therapy for thromboembolic events
- Able to adhere to study visits and protocol requirements
- Negative SARS-CoV-2 test within 7 days prior to randomization
- Negative HIV test unless stable on antiretroviral therapy with adequate immune status
- For women of childbearing potential, negative pregnancy test and agreement to avoid breastfeeding and pregnancy during and after study
- For men, agreement to use contraception or abstain from heterosexual intercourse during and after study
- Covered by social security (France)
- Understands and speaks an official language of the study country
You will not qualify if you...
- Follicular lymphoma grade 3b or follicular large B-cell lymphoma
- Suspicion or evidence of transformed lymphoma
- Prior localized radiotherapy for follicular lymphoma
- Prior history of another lymphoma
- Uncontrolled symptomatic pleural or serous effusion
- Uncontrolled symptomatic ureterohydronephrosis causing renal failure
- Symptomatic lymphomatous epidural lesion
- Use of anticancer therapy within 42 days before study treatment
- Use of systemic immunosuppressive medications or high-dose corticosteroids within 10 days prior to treatment
- Recent live attenuated vaccine within 4 weeks before treatment
- Major surgery within 28 days prior to consent
- Active or seropositive hepatitis B or C infection (with exceptions)
- Known hypersensitivity to study drugs or components
- History of organ or stem cell transplant
- Active autoimmune disease requiring treatment or history of certain autoimmune diseases
- Active infections including SARS-CoV-2, bacterial, fungal, or parasitic infections
- Significant cardiovascular, pulmonary, liver, or central nervous system disease
- History of progressive multifocal leukoencephalopathy or hemophagocytic lymphohistiocytosis
- History of severe rash or lung disease related to prior immunomodulatory treatments
- Active malignancy other than treated cancers free for at least 3 years
- Central nervous system lymphoma involvement
- Pregnant or lactating women
- Significant medical or psychiatric conditions posing risk or interfering with study
- Persons deprived of liberty or under legal protection without consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 49 locations
1
AZ SINT-JAN BRUGGE - OOSTENDE AV - Service Hématologie
Bruges, Belgium, 8000
Actively Recruiting
2
INSTITUT JULES BORDET - Service Hématologie
Brussels, Belgium, 1070
Actively Recruiting
3
UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Service Hématologie
Brussels, Belgium, 1200
Actively Recruiting
4
GRAND HOPITAL DE CHARLEROI - Service Hématologie
Charleroi, Belgium, 6000
Actively Recruiting
5
UNIVERSITAIR ZIEKENHUIS GENT - Service Hématologie
Ghent, Belgium, 9000
Actively Recruiting
6
CHU DE LIEGE - Service Hématologie
Liège, Belgium, 4000
Actively Recruiting
7
CHR VERVIERS - LA TOURELLE - Service Hématologie
Verviers, Belgium, 4800
Actively Recruiting
8
CHU UCL NAMUR - SITE GODINNE - Service Hématologie
Yvoir, Belgium, 5530
Actively Recruiting
9
CH d'AVIGNON - HOPITAL HENRI DUFFAUT - Service d'Onco-Hématologie
Avignon, France, 84000
Actively Recruiting
10
CH DE LA COTE BASQUE - Service Hématologie
Bayonne, France, 64100
Actively Recruiting
11
CHU JEAN MINJOZ - Service Hématologie
Besançon, France, 25030
Actively Recruiting
12
INSTITUT BERGONIE - Service d'Oncologie Médicale
Bordeaux, France, 33076
Actively Recruiting
13
CENTRE HOSPITALIER JEAN ROUGIER - Service d'Oncologie - Hématologie
Cahors, France, 46005
Actively Recruiting
14
CH METROPOLE SAVOIE - SITE CHAMBERY - Service Hématologie
Chambéry, France, 73011
Actively Recruiting
15
CHU ESTAING - Service Thérapie Cellulaire et Hématologie Clinique
Clermont-Ferrand, France, 63003
Actively Recruiting
16
HOPITAL HENRI MONDOR - Unité Hémopathies Lymphoïdes
Créteil, France, 94010
Actively Recruiting
17
CHU DIJON BOURGOGNE - Service Hématologie Clinique
Dijon, France, 21000
Actively Recruiting
18
CHD DE VENDEE - Service Hématologie
La Roche-sur-Yon, France, 85925
Actively Recruiting
19
CHU DE GRENOBLE - Service Hématologie
La Tronche, France, 38700
Actively Recruiting
20
HOPITAL SAINT VINCENT-DE-PAUL - Service Hématologie
Lille, France, 59020
Actively Recruiting
21
CHRU DE LILLE - HOPITAL CLAUDE HURIEZ - Service Hématologie
Lille, France, 59037
Actively Recruiting
22
CHU DE LIMOGES - HOPITAL DUPUYTREN - Service Hématologie Clinique et Thérapie Cellulaire
Limoges, France, 87042
Actively Recruiting
23
INSTITUT PAOLI CALMETTES - Service Hématologie
Marseille, France, 13273
Actively Recruiting
24
CHU DE MONTPELLIER - Département d'Hématologie Clinique
Montpellier, France, 34090
Actively Recruiting
25
GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER - Service Hématologie
Mulhouse, France, 68100
Actively Recruiting
26
CHU DE NANTES - Service Hématologie
Nantes, France, 44093
Actively Recruiting
27
CENTRE HOSPITALIER DE NIORT - Médecine interne
Niort, France, 79021
Actively Recruiting
28
HOPITAL SAINT-LOUIS - Service Hématologie
Paris, France, 75475
Actively Recruiting
29
CHU DE BORDEAUX - HOPITAL HAUT-LEVEQUE - CENTRE FRANCOIS MAGENDIE - Service d'Hématologie et Thérapie Cellulaire
Pessac, France, 33604
Actively Recruiting
30
CHU LYON-SUD - Hématologie
Pierre-Bénite, France, 69495
Actively Recruiting
31
CHI POISSY SAINT-GERMAIN-EN-LAYE - Service Hématologie
Poissy, France, 78303
Actively Recruiting
32
CHU DE POITIERS - HOPITAL DE LA MILETRIE - Service d'Oncologie Hématologique et Thérapie Cellulaire
Poitiers, France, 86021
Actively Recruiting
33
CH ANNECY GENEVOIS - SITE D'ANNECY - Service Hématologie
Pringy, France, 74374
Actively Recruiting
34
CHU DE REIMS - HOPITAL ROBERT DEBRE - Service Hématologie
Reims, France, 57092
Actively Recruiting
35
CHU PONTCHAILLOU - Hématologie Clinique
Rennes, France, 35033
Actively Recruiting
36
CENTRE HENRI BECQUEREL - Service Hématologie
Rouen, France, 76038
Actively Recruiting
37
INSTITUT CURIE - SITE SAINT-CLOUD - Service Hématologie
Saint-Cloud, France, 92210
Actively Recruiting
38
Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne - Service Hématologie
Saint-Priest-en-Jarez, France, 42270
Actively Recruiting
39
INSTITUT DE CANCEROLOGIE STRASBOURG EUROPE - Unité de Recherche Clinique
Strasbourg, France, 67033
Actively Recruiting
40
IUCT ONCOPOLE - Service Hématologie
Toulouse, France, 31059
Actively Recruiting
41
CHU BRETONNEAU - Service Cancérologie - Hématologie et Thérapie Cellulaire
Tours, France, 37044
Actively Recruiting
42
CH DE VALENCIENNES - HOPITAL JEAN BERNARD - Service Hématologie
Valenciennes, France, 59322
Actively Recruiting
43
CHU BRABOIS - Service Hématologie
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
44
CH DE BRETAGNE ATLANTIQUE - HOPITAL CHUBERT - Service Hématologie
Vannes, France, 56017
Actively Recruiting
45
GUSTAVE ROUSSY CANCER CAMPUS GRAND PARIS - Département Médecine Oncologique
Villejuif, France, 94085
Actively Recruiting
46
UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III
Regensburg, Germany, 93053
Actively Recruiting
47
UNIV KLINIKUM ULM - INNERE MEDIZIN III - Service Hématologie
Ulm, Germany, 89081
Actively Recruiting
48
INSTITUTO PORTUGUES DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL - Departamento Hematologia
Lisbon, Portugal, 1099
Actively Recruiting
49
HOSPITAL CLINICO SALAMANCA - Servicio de Hematologia
Salamanca, Spain, 37007
Actively Recruiting
Research Team
J
Julie ASSEMAT
CONTACT
M
Marion TAYOL
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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