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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02303119
Other study ID # FLIRT
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 2, 2015
Est. completion date June 29, 2021

Study information

Verified date January 2023
Source The Lymphoma Academic Research Organisation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 221
Est. completion date June 29, 2021
Est. primary completion date June 29, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 ß2 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rituximab IV
intra-venous, 375 mg/m²
Rituximab SC
sub-cutaneous, 1400 mg

Locations

Country Name City State
France 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 Creteil
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 Nimes
France CHR de la Source Orleans
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 Benite
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 Institut de Cancérologie de l'Ouest René Gauducheau Saint Herblain
France Institut de Cancérologie Lucien Neuwirth Saint Priest en Jarez
France Hôpital Yves Le Foll Saint-Brieuc
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 Vandoeuvre-les-Nancy
France CH Bretagne Atlantique Vannes

Sponsors (2)

Lead Sponsor Collaborator
The Lymphoma Academic Research Organisation Roche Pharma AG

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Pharmacokinetic parameters of rituximab will be used to estimate individual area under the concentration curves of rituximab (AUC). The AUC will be used to describe the relationship between rituximab pharmacokinetics and clinical response (objective response, survival). 5.5 years
Other Causes of death classification by cause of death 5.5 years
Other Secondary cancers classification by type of cancer 5.5 years
Other Number of SAE from the first administration for Rituximab SC as of C1 cohort 1 year
Primary 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 Overall Survival (OS) time from the date of randomization to the date of death from any cause. Alive patients will be censored at their last follow-up date. 5.5 years
Secondary Response Rates Disease response evaluation, assessment will be based on the International Workshop to Standardize Response criteria for NHL (Criteria for evaluation of response in Non-Hodgkin's lymphoma) according to Cheson 1999 (M3 and M12) and according to Cheson 2014 (M12 only).
The response rates will be described for each modality (CR, CRu, PR, SD and PD) and the Overall response rates (CR+CRu+PR) will also be described at the two time points (M3 & M12).
M3 and M12
Secondary Best Response Rate during the study Best disease response, assessment of response will be based on the International Workshop to Standardize Response criteria for NHL (Criteria for evaluation of response in Non-Hodgkin's lymphoma (Cheson, 1999)).
The response rates will be described for each modality (CR, CRu, PR, SD and PD) and the Overall response rates (CR+CRu+PR) will also be described
M3 and M12
Secondary Time to Next Anti-Lymphoma Treatment (TTNLT) time from randomization to the date of first documented administration of any new anti-lymphoma treatment (chemotherapy, radiotherapy, radio-immunotherapy, immunotherapy…). Patients continuing in response or who are lost to follow-up will be censored on their last visit date. Patients who died (due to any cause) before having received a new anti-lymphoma treatment will be included in the statistical analysis with death being counted as an event. 5.5 years
Secondary Molecular Response Bcl-2-IgH rearrangement M3 and M12
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