Panobinostat with Azacitidine in patients with leukemia

• Research type

  Research Study

• Full title

  A phase Ib/IIb, open-label, multi-center study of oral Panobinostat (LBH589) administered with 5-Azacitidine (Vidaza®) in adult patients with myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML).

• IRAS ID

  95659

• Contact name

  Jamie Cavenagh

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2009-010548-32

• ISRCTN Number

  not known

• Research summary

  This study is a phase Ib/IIb, open-label, multi-center study of oral Panobinostat (LBH589) administered with 5-Azacitidine (Vidaza©) in adult patients with myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML). This study consists of two parts; a phase Ib and a phase IIb part. The phase Ib part of the study has been completed and the highest dose of panobinostat that can be given safely at the same time with Vidaza© has been found. Additional patients will now be enrolled into the phase IIb part at that dose level to further investigate the preliminary efficacy and safety of the treatment relative to Vidaza© when given alone. 80 patients (40 in each arm) will join in this phase IIb part at centres in Northern America, Europe and Asia.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  12/LO/0085

• Date of REC Opinion

  8 Feb 2012

• REC opinion

  Further Information Favourable Opinion