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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
221
intra-venous, 375 mg/m²
sub-cutaneous, 1400 mg
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
Time frame: 5.5 years
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.
Time frame: 5.5 years
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).
Time frame: M3 and M12
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
Time frame: M3 and M12
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.
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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
...and 40 more locations
Time frame: 5.5 years
Molecular Response
Bcl-2-IgH rearrangement
Time frame: M3 and M12