Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
221 participants
INTERVENTIONAL
2015-02-02
2021-06-29
Brief Summary
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The hypothesis is that the use of rituximab by sub cutaneous route and the scheme of administration could:
* optimize rituximab exposure leading to improve response rate
* increase adaptative response and then improve long-term control disease.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Am A : Rituximab IV
4 infusions of intravenous rituximab (375mg/m²) at Day 1, Day 8, Day 15 and D22
Rituximab IV
intra-venous, 375 mg/m²
Arm B: Rituximab SC
1 infusion of intravenous rituximab (375mg/m²) at Day 1, and 7 administrations of sub-cutaneous rituximab (1400mg) at Day 8, Day15, Day 22, Month 3, Month 5, Month 7 and Month 9.
Rituximab IV
intra-venous, 375 mg/m²
Rituximab SC
sub-cutaneous, 1400 mg
Arm C : Rituximab SC first cycle
8 administrations of sub-cutaneous rituximab (1400mg) at Day 8, Day15, Day 22, Month 3, Month 5, Month 7 and Month 9.
Rituximab SC
sub-cutaneous, 1400 mg
Interventions
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Rituximab IV
intra-venous, 375 mg/m²
Rituximab SC
sub-cutaneous, 1400 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a bone marrow biopsy within 4 months before the first study drug administration
* Have no prior therapy except surgery for diagnosis
* Aged 18 years or more with no upper age limit
* ECOG performance status 0-2
* Ann Arbor Stage II, III or IV
* Bi-dimensionally measurable disease defined by at least one single node or tumor lesion \> 1.5 cm assessed by CT scan and/or clinical examination
* With low-tumor burden defined as:
* Nodal or extra-nodal tumor mass with diameter less than 7 cm in its greater diameter
* And involvement of less than 3 nodal or extra nodal sites with diameter greater than 3 cm
* And absence of B symptoms
* And no symptomatic splenomegaly
* And no compression syndrome (ureteral, orbital, gastrointestinal…)
* And no pleural or peritoneal serous effusion
* And no cytopenia, with hemoglobin \> 10 g/dL (6.25mmol/L) and absolute neutrophil count\> 1.5 G/L and platelets \> 100 G/L within 28 days before the randomization
* And LDH \< ULN within 28 days before the randomization
* And β2 microglobulin \< ULN within 28 days before the randomization
* Have signed an informed consent
* Must be covered by a social security system
Exclusion Criteria
* Ann Arbor Stage I
* Seropositive for or active viral infection with hepatitis B virus (HBV) HBs Ag positive HBs Ag negative, anti-HBs antibody positive and/or anti-HBc antibody positive and detectable viral DNA
Note:
Patients who are HBs Ag negative, anti-HBs positive and/or anti-HBc positive but viral DNA negative are eligible Patients who are seropositive due to a history of hepatitis B vaccine are eligible
* Known seropositive for, or active viral infection with hepatitis C virus (HCV)
* Known seropositive for, or active viral infection with Human Immunodeficiency Virus (HIV)
* Any of the following laboratory abnormalities within 28 days before the randomization:
Total bilirubin or GGT or AST or ALT \> 3 ULN. Calculated creatinine clearance (Cockcroft and Gault formula) \< 60 mL /min
* Presence or history of CNS involvement by lymphoma
* Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 3 years
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
* Patient with mental deficiency preventing proper understanding of the informed consent and the requirements of treatment.
* Adult under law-control
* Adult under tutelage
* Contraindication to use rituximab or known sensitivity or allergy to murine products
* Pregnant or lactating females.
* Concomitant disease requiring prolonged use of corticosteroids or corticosteroids administration for lymphoma within 28 days before the first study drug administration.
* Male and female patients of childbearing potential who cannot or do not wish to use an effective method of contraception, during the study treatment and for 12 months thereafter.
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
The Lymphoma Academic Research Organisation
OTHER
Responsible Party
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Principal Investigators
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Guillaume Cartron, MD PhD
Role: STUDY_CHAIR
Lymphoma Study Association
Locations
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CH de Pays d'Aix
Aix-en-Provence, , France
CHU Angers
Angers, , France
CH d'Avignon - Hôpital Henri Duffaut
Avignon, , France
Hôpital de Bayonnes
Bayonne, , France
CH de BLOIS
Blois, , France
Hôpital d'Avicenne
Bobigny, , France
Institut Bergonié
Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
IHBN - CHU de Caen
Caen, , France
Clinique du Parc
Castelnau-le-Lez, , France
CH de Chambéry
Chambéry, , France
Chu Estaing
Clermont-Ferrand, , France
Hôpital Pasteur
Colmar, , France
Hôpital Henri Mondor
Créteil, , France
CHU Dijon - Hôpital d'Enfants
Dijon, , France
Hôpital Albert Michallon
Grenoble, , France
CH Départemental Vendée
La Roche-sur-Yon, , France
Hôpital St Louis
La Rochelle, , France
Hôpital André Mignot
Le Chesnay, , France
Clinique Victor Hugo
Le Mans, , France
CHRU de Lille - Hôpital Claude Hurriez
Lille, , France
Centre Léon Bérard
Lyon, , France
Hôpital de la Conception
Marseille, , France
Hôpital Mercy
Metz, , France
Hôpital Saint-Eloi
Montpellier, , France
Hôpital Emile Muller
Mulhouse, , France
CHU de Nantes - Hôtel Dieu
Nantes, , France
Institut de Cancérologie du Gard Hématologie clinique
Nîmes, , France
CHR de la Source
Orléans, , France
Hôpital Cochin
Paris, , France
Hôpital Necker
Paris, , France
Hôpital Saint Jean
Perpignan, , France
Hôpital Haut Lévêque - Centre François Magendie
Pessac, , France
CHU Lyon Sud
Pierre-Bénite, , France
CH René Dubos
Pontoise, , France
Centre Hospitalier Annecy-Genevois
Pringy, , France
Hôpital Robert Debré
Reims, , France
Hôpital Pontchaillou
Rennes, , France
Hôpital Victor Provo
Roubaix, , France
Centre Henri Becquerel
Rouen, , France
Hôpital Yves Le Foll
Saint-Brieuc, , France
Institut de Cancérologie de l'Ouest René Gauducheau
Saint-Herblain, , France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, , France
Hôpital de Hautepierre
Strasbourg, , France
IUCT Oncopole
Toulouse, , France
Hôpital Bretonneau
Tours, , France
CH de TROYES
Troyes, , France
CH de Valenciennes
Valenciennes, , France
CHU Nancy - Hôpital de Brabois
Vandœuvre-lès-Nancy, , France
CH Bretagne Atlantique
Vannes, , France
Countries
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References
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Cartron G, Bachy E, Tilly H, Daguindau N, Pica GM, Bijou F, Mounier C, Clavert A, Damaj GL, Slama B, Casasnovas O, Houot R, Bouabdallah K, Sibon D, Fitoussi O, Morineau N, Herbaux C, Gastinne T, Fornecker LM, Haioun C, Launay V, Araujo C, Benbrahim O, Sanhes L, Gressin R, Gonzalez H, Morschhauser F, Ternant D, Xerri L, Tarte K, Pranger D. Randomized Phase III Trial Evaluating Subcutaneous Rituximab for the First-Line Treatment of Low-Tumor Burden Follicular Lymphoma: Results of a LYSA Study. J Clin Oncol. 2023 Jul 1;41(19):3523-3533. doi: 10.1200/JCO.22.02327. Epub 2023 Apr 18.
Other Identifiers
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FLIRT
Identifier Type: -
Identifier Source: org_study_id
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