Phase I/II Study With Oral Panobinostat Maintenance Therapy Following Allogeneic Stem Cell Transplantation in Patients With High Risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) (PANOBEST)

Inclusion Criteria:

• AML (except acute promyelocytic leukemia, AML M3) with high-risk features defined as one or more of the following criteria:

  • refractory to or relapsed after at least one cycle of standard chemotherapy
  • > 10% bone marrow blasts at day 15 of the first induction cycle
  • adverse risk cytogenetics including complex karyotype (≥ 3 abnormalities or abnormalities of chromosomes 3, 5 or 7) regardless of stage
  • secondary to MDS or radio-/chemotherapy or
• MDS RAEB according to the WHO classification or intermediate-2 or high-risk according to IPSS or

• Chronic myelomonocytic leukemia (CMML) with ≥ 5% bone marrow blasts and

  • Allogeneic HSCT with reduced intensity conditioning (see Section 15.1 for definition) performed within 60 - 150 days prior to study entry
  • Complete hematologic remission documented by bone marrow aspiration within 28 days prior to study entry

Exclusion Criteria:

• Active acute GvHD overall grade 2 - 4
• Prior treatment with a deacetylase (DAC) inhibitor
• Patients with impaired cardiac function or other concurrent severe and/or uncontrolled medical conditions
• Clinical symptoms suggesting central nervous system (CNS) leukemia
• Patient has an impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral panobinostat