Assess the combination of efficacy of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma.
Assess the combination of efficacy and safety of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma who are refractory or in relapse.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv Dexamethasone 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv
Response Rate
The primary endpoint is the number of Participants with Response according to the criteria of the International Workshop to Standardize Response Criteria for NHL Complete Remission (CR): Nodes returned to normal (if GTD \>15 mm before therapy, GTD now ≤15 mm; if GTD 11-15 and SA \>10 mm before therapy, SA now ≤10 mm) All (non-nodal) target lesions completely resolved Partial Remission (PR) SPD of target lesions decreased ≥50% from baseline Spleen and liver nodules regress by 50% in SPD or single lesion in GTD Stable Disease (SD) Not enough shrinkage for PR Not enough growth for PD Progressive Disease (PD): SPD increase ≥50% from nadir (smallest value seen during trial) in nodal target lesions overall or in any single nodal target lesion
Time frame: 7 years
Secondary Endpoints Included an Assessment of the Following Parameters: Progression-Free Survival, Disease-Free Survival, Global Survival, Duration of the Response.
Time frame: 7 years
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Complejo Hospitalario Universitario de Santiago
Santiago, A Coruña, Spain
Hospital Txagorritxu
Vitoria-Gasteiz, Alava, Spain
Hospital San Juan de Alicante
Sant Joan d'Alacant, Alicante, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital de Galdakao
Galdakao, Bilbao, Spain
Hospital Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital de Jerez
Jerez de la Frontera, Cádiz, Spain
Hospital Fundación de Alcorcón
Alcorcón, Madrid, Spain
Hospital de Getafe
Getafe, Madrid, Spain
Hospital Severo Ochoa
Leganés, Madrid, Spain
...and 31 more locations