A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma (PATH)

• To compare Overall Survival (OS) for the two arms [ Time Frame: 60 months ] [ Designated as safety issue: No ]
• To estimate and compare the rate of relapse (RoR) at 6, 12, and 24 months from randomization for the two arms [ Time Frame: 60 months ] [ Designated as safety issue: No ]
• To characterize the safety and tolerability of panobinostat Exploratory [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
• To assess the safety and tolerability of panobinostat [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
• To explore the relationship of Pharmacokinetics-pharmacodynamics (PK-PD) (safety and efficacy) in patients with HL following AHSCT [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]

• To compare OS for the two arms [ Time Frame: 60 months ] [ Designated as safety issue: No ]
• To estimate and compare the rate of relapse (RoR) at 6, 12, and 24 months from randomization for the two arms [ Time Frame: 60 months ] [ Designated as safety issue: No ]
• To characterize the safety and tolerability of panobinostat Exploratory [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
• To assess the safety and tolerability of panobinostat [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
• To explore the relationship of Pharmacokinetics-pharmacodynamics (PK-PD) (safety and efficacy) in patients with HL following AHSCT [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]

The purpose of this phase III study is to evaluate the efficacy of orally-administered panobinostat in reducing the risk of relapse in patients with classical Hodgkin's Lymphoma who achieved a complete response following high-dose chemotherapy (HDT) with Autologous stem cell transplant(AHSCT).

• Drug: Panobinostat
  Other Name: LBH589
• Drug: Placebo
  Placebo

• Experimental: Panobinostat
  Intervention: Drug: Panobinostat
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

Inclusion Criteria:

1. Patient age is greater than or equal to 18 years
2. Patient has a history of histologically confirmed classical HL (i.e. Nodular sclerosing (NSHL), Mixed-cellularity (MCHL), Lymphocyte-rich (LRHL), Lymphocyte depleted (LDHL))

3. Patient has achieved a complete response by CT/MRI scan within 9 weeks (± 1 week) from the day of their first autologous peripheral blood/ bone marrow stem cell transfusion (AHSCT) following HDT. Complete response is defined as:

   Normalization of all nodes and lesions compared to pre-transplant scan performed prior to salvage therapy for relapse. Any residual abnormal masses on the post transplant CT/MRI must be metabolically inactive on a PET scan.

4. Patient has at least one of the following factors that places them at risk for relapse:

   • Primary refractory disease (including relapse in ≤ 3 months of completion of 1st line treatment)
   • First relapse >3 but <12 months from last dose of 1st line treatment
   • Multiple relapses (prior to transplant)
   • Stage III/IV disease (at relapse, prior to transplant)
   • Hemoglobin <10.5 gm/dL (at relapse, prior to transplant)

Exclusion Criteria:

Patient has been treated with allogeneic transplant 2. Patient has received any anti-lymphoma therapy after AHSCT including but not limited to:

• chemotherapy prior to start of study
• biologic immunotherapy including monoclonal antibodies or experimental therapy prior to start of study
• radiation therapy 3. Patient has not recovered from reversible toxicity due to any prior therapies (e.g. returned to baseline or Grade ≤1) except for hematological laboratory parameters Note: Patient does not meet this criteria if the toxicity is stable and irreversible, and there is no evidence that panobinostat causes a similar toxicity 4. Patient has received prior treatment with DAC inhibitors including panobinostat

Other protocol-defined inclusion/exclusion criteria may apply