A Phase 2 Study of Panobinostat in Hodgkin Lymphoma
Research type
Research Study
Full title
A phase II study of oral Panobinostat in adult patients with relapsed/refractory classical Hodgkin’s Lymphoma after failure of high-dose chemotherapy with autologous stem cell transfusion and a Gemcitabine- or Vinorelbine- or Vinblastine-containing treatment regimen.
IRAS ID
7227
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2008-003016-35
Clinicaltrials.gov Identifier
Research summary
There are currently no treatments available that are proven to be effective in patients with Hodgkin Lymphoma, whose disease has reoccurred or does not respond to standard treatments. The purpose of this study is to see if this new compound, Panobinostat will be an effective treatment for patients with Hodgkin Lymphoma, who have been previously treated with high dose chemotherapy with stem cell transplant and other treatments and who have not benefited from them.Panobinostat has shown to be effective in laboratory studies and has encouraging early clinical results in a small number of patients.All patients in this study (between 35 and 102 patients around the world) will receive Panobinostat as the only treatment. They will receive the treatment orally three times a week for as long as they and their study doctor feels that they are benefiting. Patients will visit the study doctor on a regular basis for health checks, blood tests and ECGs and a have CT scan every 6 weeks.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
09/H1008/6
Date of REC Opinion
5 Mar 2009
REC opinion
Further Information Favourable Opinion