Acute Myeloid Leukemia Clinical Trial
Official title:
Phase I/II Study With Oral Panobinostat Maintenance Therapy Following Allogeneic Stem Cell Transplantation in Patients With High Risk MDS or AML (PANOBEST)
The study's primary objective is to determine the maximum tolerated dose (MTD) and
dose-limiting toxicity (DLT) of Panobinostat when administered within 150 days after
hematopoietic stem cell transplantation (HSCT) and given in conjunction with standard
immunosuppressive therapy after HSCT for patients with high-risk Myelodysplastic Syndrome
(MDS) or Acute Myeloid Leukemia (AML).
Secondary objectives are
- To determine safety and tolerability of panobinostat
- To determine overall and disease-free survival at 12 months after HSCT
- To evaluate immunoregulatory properties of panobinostat
- To evaluate patient-reported health-related quality of life (HRQL)
The hypothesis of this study is that panobinostat can be an effective drug in preventing
relapse of MDS and AML patients with high-risk features after hematopoietic stem cell
transplantation with reduced-intensity conditioning (RIC-HSCT) while at the same time
reducing graft-versus-host disease (GvHD) with preservation of graft-versus-leukemia (GvL)
effect.
n/a
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