Hodgkin Lymphoma Treatment With Adcetris and Levact in the Old Patient
Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
Treatment outcome with ABVD in elderly patients remains inferior to adults. Moreover,
Bleomycin-induced lung toxicity in the elderly has been reported as high as 46%. For these
reasons, questions arise whether ABVD could be still considered the standard treatment in HL
patients aged > than 60. Regimens containing other alkylators such as CHOP proved even
superior to ABVD, with a 3-y PFS of 67%. Frontline treatment of advanced-stage HL with
Brentuximab Vedotin (BV) in association with AVD (Doxorubicin, Vinblastine, Dacarbazine)
proved very active in a pioneer study, reporting the preliminary results of a phase 1
multicentre trial, in which the percentage of patients achieving CR was as high as 92%. For
all these reason the investigators decided to test the association of an alkylator with an
innovative mechanism of action and a very safe toxicity profile in the elderly such as
Bendamustine (Be) with BV in untreated elderly HL patients.
The combination of BV and Be, investigated in this study, might represent an innovative
treatment alternative for HL patients older than 60 years of age, especially for those of
them in whom ABVD chemotherapy, the current standard front-line treatment, is not suitable.
However, even when ABVD is given as upfront treatment for elderly HL patients, it is
associated with substantial dose reduction, treatment delay, toxicity, and treatment-related
mortality, with treatment outcomes remaining much inferior to those obtained in younger
patients. This drug association is expected to be safe, well-tolerated and to demonstrate
higher efficiency compared with ABVD. In this setting, it is expected that this therapy could
be offered to the large majority of elderly patients with a full treatment completion reached
in up to 80% of these patients.
Thus, the aim of this study will be to assess safety and efficacy of the above association.