panobinostat in patients with Hodgkin’s lymphoma

• Research type

  Research Study

• Full title

  A Phase III randomized, double blind, placebo controlled, multicenter study of panobinostat for maintenance of response in patients with Hodgkin’s lymphoma who are at risk for relapse after high dose chemotherapy and autologous stem cell transplant

• IRAS ID

  44991

• Contact name

  Nagesh Kalakonda

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2009-014846-26

• Research summary

  Hodgkin??s lymphoma (HL) is a disease typically involving lymph nodes characterized by the presence of Reed-Sternberg cells, which are derived from B lymphocytes, associated with a surrounding proliferation of mature Tcells. In patients with classical HL, who undergo autologous hematopoietic stem cell transplant (AHSCT), a complete response can be achieved in 30-60% of patients. However, 40-50% of the patients will subsequently relapse. Panobinostat (LBH589) is an orally-administered deacetylase inhibitor (DACi) belonging to a structurally novel cinnamic hydroxamic acid class of compounds. It is a potent pan-DAC inhibitor (pan-DACi) that has shown antitumor activity in both pre-clinical models and cancer patients. The purpose of this phase III study is to evaluate the efficacy of orally administered panobinostat in a maintenance setting for patients with classical HL who achieved a complete response following high dose chemotherapy (HDT) with AHSCT and are classified as at risk for relapse. Currently, patients who achieve a complete response following HDT with AHSCT are followed under observation without treatment until relapse. Because observation is the standard of care, a two arm placebo-controlled (active treatment with panobinostat vs. placebo) study is considered appropriate.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  10/H1002/32

• Date of REC Opinion

  30 Jun 2010

• REC opinion

  Favourable Opinion