Etude : FLIRT /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : FLIRT

Nom :

Traitement :

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 18/10/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A RANDOMIZED PHASE III TRIAL EVALUATING TWO STRATEGIES OF RITUXIMAB ADMINISTRATION FOR THE TREATMENT OF FIRST LINE/LOW TUMOR BURDEN FOLLICULAR LYMPHOMA

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C82 - Lymphome folliculaire
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : 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.

Active Comparator: Am A : Rituximab IV
4 infusions of intravenous rituximab (375mg/m²) at Day 1, Day 8, Day 15 and D22

Experimental: 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.

Experimental: 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.

Phase : III

Stade : NA

NA
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : 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

Critères de non-inclusion : 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.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT02303119
Promoteur :
lysarc
Type de sponsor : Institutionnel
Centre hospitalier Lyon sud, secteur sainte Eugénie, pavillon 6E
69001 LYON 01

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Henri Becquerel - Rue d'Amiens CS 11516 - Cedex 1 - 76000 ROUEN

Investigateur :
Hervé TILLY

TEC / ARC / IDE :
Delphine ROBBE
delphine.robbe@
chb.unicancer.fr
02.32.08.22.20

Ouverture de l'essai : OUVERT

MAJ : 18/10/2019