Open Label, Uncontrolled, Pilot, Phase II Study of Histone-deacetylase Inhibitor ITF2357 Administered Orally to Subjects With Chronic Lymphocytic Leukemia (CLL) Refractory/Relapsed After Conventional Chemotherapy or Relapsed After Autologous Bone Marrow Transplantation
CLL is the most frequent type of leukemia in the western world and affects mainly elderly
individuals, although about one third of patients are less than 60 years of age at
CLL is a heterogeneous disease characterised by a surprisingly diverse clinical course with
patients that may have an overall survival time ranging from months to decades.
CLL accounts for approximately 7000 new cases and 4500 deaths per year in the US.
Chemotherapeutic treatment of CLL is largely ineffective and despite new emerging
therapies, CLL still remains an incurable disease.
ITF 2357 is a novel and proprietary molecule synthesized by Italfarmaco S.p.A. Research
Laboratories, provided with an established and powerful HDAC-inhibitory activity (see below
for further details). It is being developend for a range of possible clinical applications
both in oncohaematological conditions and in chronic inflammatory diseases. The former
application is consistent with the well known antitumor pharmacological properties of
HDAC-inhibitors as a family (i.e. cell-cycle arrest, pro-apoptotic and cell-differentiating
effects); the latter application (chronic inflammation) is based of the demonstrated
anticytokine effect of ITF 2357.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine overall response-rate, complete response (CR) or partial response (PR) to ITF2357 given at 100 mg x 2/die for up to three months
Massimo Martelli, MD
Department of Internal Medicine and Public Health, University of Perugia
Italy: Ministry of Health