Phase I/II Study With Oral Panobinostat Maintenance Therapy Following Allogeneic Stem Cell Transplantation in Patients With High Risk MDS or 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