This study evaluates bendamustine in patients aged over 60 years with classical Hodgkin Lymphoma treated by prednisone, vinblastine and doxorubicin. 90 patients will be enrolled in this study.
The usual treatment for Hodgkin lymphoma is chemotherapy Adriamycin (also known as doxorubicin) + Bleomycin + Vinblastine + Dacarbazine (ABVD). Studies have shown that patients aged over 60 years have a lower tolerance and efficiency during this treatment than younger patients. There are particular pulmonary toxicities with bleomycin included in the ABVD treatment. Alternative treatment strategies have been proposed removing bleomycin in the Prednisone + Vinblastine + Adriamycin/Doxorubicin +Gemcitabine (PVAG) protocol evaluated in more than 60 patients. Compared to ABVD treatment, PVAG treatment presented a more favorable toxicity profile. The quality of response between the two treatments is substantially equal. Bendamustine was evaluated in four studies in patients with Hodgkin lymphoma in relapse and showed higher efficacy than gemcitabine with an acceptable toxicity profile. In this study, the Sponsor and the coordinating investigator propose to replace dacarbazine in the standard ABVD protocol by bendamustine and to stop using bleomycin. The main objective of this study is to evaluate the safety and efficacy of bendamustine in patients treated with prednisone, vinblastine and doxorubicin. This is the PVAB treatment with which LYSARC and the coordinating investigator expect better tolerability and quality response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Bendamustine 120 mg/m2 (IV) Day 1
Prednisone 40 mg/m² PO
Vinblastine 6 mg/m² IV
Complete Metabolic Response rate at the end of study treatment (after 6 cycles of study treatment or at premature treatment discontinuation) defined according to Lugano Classification
Complete Metabolic Response rate at the end of study treatment (after 6 cycles of study treatment or at premature treatment discontinuation) defined according to Lugano Classification
Time frame: 3 years
Feasibility of the protocol, with adequate protocol adherence (adequate dose without excessive delay)
Feasibility of the protocol, with adequate protocol adherence (adequate dose without excessive delay)
Time frame: 5 years
Safety profile including immediate toxicities and non-tumor events
Safety profile including immediate toxicities and non-tumor events
Time frame: 5 years
Progression-free survival
Progression-free survival
Time frame: 5 years
Disease-free survival
Disease-free survival
Time frame: 5 years
Overall survival
Overall survival
Time frame: 5 years
Geriatric assessment program
7 Quality of Life Questionnaires (QLQ)
Time frame: 5 years
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