Myelodysplastic Syndromes Clinical Trial
Official title:
A Pilot Study of Pacritinib in Combination With Low Dose Decitabine in Patients With Intermediate-High Risk Myelofibrosis or MPN/MDS Syndromes
For the first 28 day cycle, all patients will be treated with single agent pacritinib at 200
mg twice daily. The investigators chose this starting dose based on the previous three phase
I studies of pacritinib as a single agent which showed that the maximum tolerated dose (MTD)
to be 500 mg, and subsequently, the dose of 400 mg daily was recommended for the phase II
studies.
Recently, the results of the phase III PERSIST-1 trial comparing pacritinib to best
available therapy (BAT) in patients with MF was reported at the 2015 American Society of
Clinical Oncology (ASCO) annual meeting. Pacritinib was found to be significantly more
effective than BAT at reducing spleen volume at 24 weeks of therapy and improving
constitutional symptoms.
Low dose decitabine has demonstrated depletion of DNMT1 in normal hematopoietic stem cells
(HSC) without cytotoxicity and subcutaneous (SC) instead of intravenous (IV) administration
may avoid high peak levels that can cause apoptosis. Furthermore, the low toxicity
associated with low dose decitabine would allow for more frequent (1 to 3 times weekly)
administration of the drug which would catch more cells in S-phase via greater exposure
time. Based on these findings, a starting dose of decitabine 5 mg/m2 SC twice weekly should
be well tolerated and effective in patients with MF and MPN/MDS syndromes when combined with
pacritinib 400 mg daily.
n/a
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