Hodgkin Lymphoma Clinical Trial
Official title:
A Phase II, Multicenter, Open Label Study of Treatment Intensification With ACVD and Brentuximab-Vedotin in Advanced-stage Hodgkin Lymphoma Patients With a Positive Interim PET Scan After 2 ABVD Cycles
This is a prospective, multi-center, open-label, phase II clinical trial, aims to assess the effectiveness of the combination ACVD (Adriamycin, Cyclophosphamide, Vinblastine and Dacarbazine) and BV (Brentuximab Vedotin) in PET-2 positive advanced-stage HL patients, in order to improve the overall long-term disease control in the entire cohort of advanced-stage HL.
With the aim of reducing Blemoycin pulmonary injury (BPI) , Bleomycin was withdrawn and
substituted with Cyclophosphamide (ACVD cycle) in patients with a PET-2 negative. All
advanced stage HL patients will receive 2 cycles of the standard treatment ABVD and assessed
with PET-2 scan.
Knowing that Cyclophosphamide toxicities include cytopenias, amenorrhea and male infertility.
These toxicities are mainly dependent on the total cumulative dose. Doses less than 4 g/m2
are not associated with sterility or major toxicity, doses higher than this can lead to
azoospermia which was reversible in many cases therefore the cumulative dose will be used in
this study is 3200 mg. Additionally, Brentuximab Vedotin has shown significant activity in
relapsed refractory HL with minor toxicities.
PET scan after 2 cycles of ABVD has proven to be an excellent tool to identify patients that
will have long term PFS of 95% when it is negative and only progression-free survival (PFS)
of less than 15% when it is positive.
The primary endpoint of the study will be to assess the overall 3-Y PFS of the entire cohort
of patients.
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