drugset / Trial / NCT00691938
LBH589 Plus Decitabine for Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study is designed to evaluate the combination of LBH589 and decitabine in patients age ≥ 60 years with high risk Myelodysplastic Syndrome (IPSS Int-2 or High) or Acute Myeloid Leukemia.
Timeline
- Start
- 2008-06
- Primary completion
- 2013-07
- Completion
- 2014-08
Publications
- Background Cashen, A., G. J. Schiller, et al. (2006). Phase II Study of Low-Dose Decitabine for the Front-Line Treatment of Older Patients with Acute Myeloid Leukemia (AML). ASH Annual Meeting Abstracts 108(11): 1984.
- Uy GL, Duncavage EJ, Chang GS, Jacoby MA, Miller CA, Shao J, Heath S, Elliott K, Reineck T, Fulton RS, Fronick CC, O'Laughlin M, Ganel L, Abboud CN, Cashen AF, DiPersio JF, Wilson RK, Link DC, Welch JS, Ley TJ, Graubert TA, Westervelt P, Walter MJ. Dynamic changes in the clonal structure of MDS and AML in response to epigenetic therapy. Leukemia. 2017 Apr;31(4):872-881. doi: 10.1038/leu.2016.282. Epub 2016 Oct 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Decitabine | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Panobinostat | Small molecule | 10 mg | — |
| Subject | Panobinostat | Small molecule | 15 mg | — |
| Subject | Panobinostat | Small molecule | 20 mg | — |
| Subject | Panobinostat | Small molecule | 30 mg | — |
| Subject | Panobinostat | Small molecule | 40 mg | — |