Follicular Lymphoma IV/SC Rituximab Therapy (FLIRT)
Conditions
Follicular Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Follicular
Conditions: Keywords
LNH, CD20+, follicular
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Rituximab IV Type: Drug
Name: Rituximab SC Type: Drug
Overall Status
Recruiting
Summary
Patient will receive either one infusion of rituximab IV and seven administrations of rituximab SC (experimental arm) or four infusions of rituximab IV (standard arm).

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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histologically confirmed follicular lymphoma CD20+ grade 1, 2 and 3a by biopsy within 4 months before signing informed consent

- 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:

- Grade 3b follicular lymphoma

- 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.
Locations
CHU Angers
Angers, France
Status: Recruiting
Contact: Marie Pierre Moles Moreau, MD - + 33 (0)2 41 35 44 75 - mpmoles@chu-angers.fr
CH d'Avignon - Hôpital Henri Duffaut
Avignon, France
Status: Recruiting
Contact: Borhane Slama, MD - + 33 (0)4 32 75 31 21 - b.slama@ch-avignon.fr
Institut Bergonié
Bordeaux, France
Status: Recruiting
Contact: Fontanet Bijou, MD - + 33 (0)5 56 33 33 39 - f.bijou@bordeaux.unicancer.fr
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
Status: Recruiting
Contact: Olivier Fitoussi, MD - + 33 (0)5 56 43 73 54 - o.fitoussi@bordeauxnord.com
CH de Chambéry
Chambéry, France
Status: Recruiting
Contact: Gian-Matteo Pica, MD - + 33 (0)4 79 96 51 05 - gian-matteo.pica@ch-chambery.fr
Chu Estaing
Clermont Ferrand, France
Status: Recruiting
Contact: Olivier Tournilhac, MD PhD - + 33 (0)4 73 75 00 65 - otournilhac@chu-clermontferrand.fr
Hôpital Henri Mondor
Creteil, France
Status: Recruiting
Contact: Corinne Haioun, MD PhD - + 33 (0)1 49 81 20 51 - corinne.haioun@hmn.aphp.fr
CHU Dijon - Hôpital d'Enfants
Dijon, France
Status: Recruiting
Contact: Olivier Casasnovas, MD - + 33 (0)3 80 29 50 41 - olivier.casasnovas@chu-dijon.fr
Hôpital Albert Michallon
Grenoble, France
Status: Recruiting
Contact: Remi Gressin, MD - + 33 (0)4 76 76 57 12 - rgressin@chu-grenoble.fr
CH Départemental Vendée
La Roche sur Yon, France
Status: Recruiting
Contact: Nadine Morineau, MD - + 33 (0)2 51 44 61 73 - nadine.morineau@chd-vendee.fr
Hôpital André Mignot
Le Chesnay, France
Status: Recruiting
Contact: Hassan Farhat, MD - + 33 (0)1 39 63 89 09 - hfarhat@ch-versailles.fr
Clinique Victor Hugo
Le Mans, France
Status: Recruiting
Contact: Katell Le Du - + 33 (0)2 43 47 94 94 - k.ledu@cjb72.org
CHRU de Lille - Hôpital Claude Hurriez
Lille, France
Status: Recruiting
Contact: Franck Morschhauser, MD - + 33 (0)3 20 44 60 68 - franck.morschhauser@chru-lille.fr
Centre Léon Bérard
Lyon, France
Status: Recruiting
Contact: Emmanuelle Nicolas Virelizier, MD - + 33 (0)4 78 78 26 84 - emmanuelle.nicolas@lyon.unicancer.fr
Hôpital Saint-Eloi
Montpellier, France
Status: Recruiting
Contact: Guillaume Cartron, MD PhD - + 33 (0)4 67 33 83 55 - g-cartron@chu-montpellier.fr
Hôpital Emile Muller
Mulhouse, France
Status: Recruiting
Contact: Jean Claude Eisenmann, MD - + 33 (0)3 89 64 77 55 - eisenmannj@ch-mulhouse.fr
CHU de Nantes - Hôtel Dieu
Nantes, France
Status: Recruiting
Contact: Steven Le Gouill, MD PhD - + 33 (0)2 40 08 32 71 - steven.legouill@chu-nantes.fr
Hôpital Universitaire Caremeau
Nimes, France
Status: Recruiting
Contact: Agathe Rascalou Waultier, MD - + 33 (0)4 66 68 32 31 - agathe.WAULTIER.RASCALOU@chu-nimes.fr
Hôpital Necker
Paris, France
Status: Recruiting
Contact: Richard Delarue, MD - + 33 (0)1 44 49 54 16 - richard.delarue@nck.aphp.fr
Hôpital Saint Jean
Perpignan, France
Status: Recruiting
Contact: Laurence Sahnes, MD - + 33 (0)4 68 61 64 48 - laurence.sanhes@ch-perpignan.fr
Hôpital Haut Lévêque - Centre François Magendie
Pessac, France
Status: Recruiting
Contact: Kamal Bouabdallah, MD - + 33 (0)5 57 65 65 11 - krimo.bouabdallah@chu-bordeaux.fr
CHU Lyon Sud
Pierre Benite, France
Status: Recruiting
Contact: Gilles Salles, MD PhD - + 33 (0)4 78 86 43 02 - gilles.salles@chu-lyon.fr
CH René Dubos
Pontoise, France
Status: Recruiting
Contact: Hugo Gonzalez, MD - + 33 (0)1 30 75 49 28 - hugo.gonzalez@ch-pontoise.fr
Centre Hospitalier Annecy-Genevois
Pringy, France
Status: Recruiting
Contact: Nicolas Daguindau, MD - + 33 (0)4 50 63 58 91 - ndaguindau@ch-annecygenevois.fr
Hôpital Robert Debré
Reims, France
Status: Recruiting
Contact: Alain Delmer, MD PhD - + 33 (0)3 26 78 36 44 - adelmer@chu-reims.fr
Hôpital Pontchaillou
Rennes, France
Status: Recruiting
Contact: Thierry Lamy de la Chapelle, MD PhD - + 33 (0)2 99 28 93 12 - thierry.lamy.de.la.chapelle@chu-rennes.fr
Centre Henri Becquerel
Rouen, France
Status: Recruiting
Contact: Hervé Tilly, MD PhD - + 33 (0)2 32 08 22 23 - herve.tilly@chb.unicancer.fr
Institut de Cancérologie de l'Ouest René Gauducheau
Saint Herblain, France
Status: Recruiting
Contact: Philippe Solal Celigny, MD - + 33 (0)2 40 67 99 00 - philippe.solal-celigny@ico.unicancer.fr
Institut de Cancérologie Lucien Neuwirth
Saint Priest en Jarez, France
Status: Recruiting
Contact: Christiane Mounier, MD - + 33 (0)4 77 91 70 61 - christiane.mounier@icloire.fr
Hôpital Yves Le Foll
Saint-Brieuc, France
Status: Recruiting
Contact: Vincent Launay, MD - + 33 (0)2 96 01 70 82 - vincent.launay@ch-stbrieuc.fr
Hôpital de Hautepierre
Strasbourg, France
Status: Recruiting
Contact: Luc Matthieu Fornecker, MD - + 33 (0)3 88 12 76 67 - luc-matthieu.fornecker@chru-strasbourg.fr
IUCT Oncopole
Toulouse, France
Status: Recruiting
Contact: Loïc Ysebaert, MD - + 33 (0)5 61 77 20 78 - ysebaert.loic@iuct-oncopole.fr
Hôpital Bretonneau
Tours, France
Status: Recruiting
Contact: Emmanuel Gyan, MD PhD - + 33 (0)2 47 47 37 12 - emmanuel.gyan@univ-tours.fr
CH de Valenciennes
Valenciennes, France
Status: Recruiting
Contact: Sabine Tricot, MD - + 33 (0)3 27 14 36 07 - tricot-s@ch-valenciennes.fr
CHU Nancy - Hôpital de Brabois
Vandoeuvre-les-Nancy, France
Status: Recruiting
Contact: Pierre Feugier, MD PhD - + 33 (0)3 83 15 32 82 - p.feugier@chu-nancy.fr
CH Bretagne Atlantique
Vannes, France
Status: Recruiting
Contact: Pascal Godmer, MD - + 33 (0)2 97 01 41 45 - pascal.godmer@ch-bretagne-atlantique.fr
Start Date
February 2015
Completion Date
January 2021
Sponsors
The Lymphoma Academic Research Organisation
Source
The Lymphoma Academic Research Organisation
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page