Follicular Lymphoma IV/SC Rituximab Therapy (FLIRT)
FLIRT
A Randomized Phase III Trial Evaluating Two Strategies of Rituximab Administration for the Treatment of First Line/Low Tumor Burden Follicular Lymphoma (Follicular Lymphoma IV/SC Rituximab Therapy)
1 other identifier
interventional
221
1 country
50
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2015
Longer than P75 for phase_3
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2014
CompletedFirst Posted
Study publicly available on registry
November 27, 2014
CompletedStudy Start
First participant enrolled
February 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2021
CompletedJanuary 10, 2023
January 1, 2023
6.4 years
November 25, 2014
January 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
Time from randomization into the study to the first observation of documented disease progression or death due to any cause. If a subject has not progressed or died, PFS will be censored at the time of last visit with adequate assessment
5.5 years
Secondary Outcomes (5)
Overall Survival (OS)
5.5 years
Response Rates
M3 and M12
Best Response Rate during the study
M3 and M12
Time to Next Anti-Lymphoma Treatment (TTNLT)
5.5 years
Molecular Response
M3 and M12
Other Outcomes (4)
Pharmacokinetic parameters of rituximab will be used to estimate individual area under the concentration curves of rituximab (AUC).
5.5 years
Causes of death
5.5 years
Secondary cancers
5.5 years
- +1 more other outcomes
Study Arms (3)
Am A : Rituximab IV
ACTIVE COMPARATOR4 infusions of intravenous rituximab (375mg/m²) at Day 1, Day 8, Day 15 and D22
Arm B: Rituximab SC
EXPERIMENTAL1 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.
Arm C : Rituximab SC first cycle
EXPERIMENTAL8 administrations of sub-cutaneous rituximab (1400mg) at Day 8, Day15, Day 22, Month 3, Month 5, Month 7 and Month 9.
Interventions
intra-venous, 375 mg/m²
sub-cutaneous, 1400 mg
Eligibility Criteria
You may qualify if:
- 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
- +4 more criteria
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Lymphoma Academic Research Organisationlead
- Roche Pharma AGcollaborator
Study Sites (50)
CH de Pays d'Aix
Aix-en-Provence, 13606, France
CHU Angers
Angers, 49933, France
CH d'Avignon - Hôpital Henri Duffaut
Avignon, 84902, France
Hôpital de Bayonnes
Bayonne, 64100, France
CH de BLOIS
Blois, 41016, France
Hôpital d'Avicenne
Bobigny, 93009, France
Institut Bergonié
Bordeaux, 33076, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300, France
IHBN - CHU de Caen
Caen, 14033, France
Clinique du Parc
Castelnau-le-Lez, 34170, France
CH de Chambéry
Chambéry, 73011, France
Chu Estaing
Clermont-Ferrand, 63003, France
Hôpital Pasteur
Colmar, 68024, France
Hôpital Henri Mondor
Créteil, 94010, France
CHU Dijon - Hôpital d'Enfants
Dijon, 21000, France
Hôpital Albert Michallon
Grenoble, 38043, France
CH Départemental Vendée
La Roche-sur-Yon, 85925, France
Hôpital St Louis
La Rochelle, 17019, France
Hôpital André Mignot
Le Chesnay, 78157, France
Clinique Victor Hugo
Le Mans, 72015, France
CHRU de Lille - Hôpital Claude Hurriez
Lille, 59037, France
Centre Léon Bérard
Lyon, 69373, France
Hôpital de la Conception
Marseille, 13385, France
Hôpital Mercy
Metz, 57085, France
Hôpital Saint-Eloi
Montpellier, 34295, France
Hôpital Emile Muller
Mulhouse, 68070, France
CHU de Nantes - Hôtel Dieu
Nantes, 44093, France
Institut de Cancérologie du Gard Hématologie clinique
Nîmes, 30029, France
CHR de la Source
Orléans, 45067, France
Hôpital Cochin
Paris, 75679, France
Hôpital Necker
Paris, 75743, France
Hôpital Saint Jean
Perpignan, 66046, France
Hôpital Haut Lévêque - Centre François Magendie
Pessac, 33604, France
CHU Lyon Sud
Pierre-Bénite, 69310, France
CH René Dubos
Pontoise, 95300, France
Centre Hospitalier Annecy-Genevois
Pringy, 74374, France
Hôpital Robert Debré
Reims, 51092, France
Hôpital Pontchaillou
Rennes, 35033, France
Hôpital Victor Provo
Roubaix, 59100, France
Centre Henri Becquerel
Rouen, 76038, France
Hôpital Yves Le Foll
Saint-Brieuc, 20000, France
Institut de Cancérologie de l'Ouest René Gauducheau
Saint-Herblain, 44805, France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42271, France
Hôpital de Hautepierre
Strasbourg, 67098, France
IUCT Oncopole
Toulouse, 31059, France
Hôpital Bretonneau
Tours, 37044, France
CH de TROYES
Troyes, 10003, France
CH de Valenciennes
Valenciennes, 59322, France
CHU Nancy - Hôpital de Brabois
Vandœuvre-lès-Nancy, 54500, France
CH Bretagne Atlantique
Vannes, 56017, France
Related Publications (1)
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.
PMID: 37071836DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Guillaume Cartron, MD PhD
Lymphoma Study Association
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2014
First Posted
November 27, 2014
Study Start
February 2, 2015
Primary Completion
June 29, 2021
Study Completion
June 29, 2021
Last Updated
January 10, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share