Skip to main content
. Author manuscript; available in PMC: 2017 Dec 1.
Published in final edited form as: Expert Opin Investig Drugs. 2016 Oct 31;25(12):1393–1403. doi: 10.1080/13543784.2016.1250882

Table 4.

Ongoing clinical trials of ruxolitinib-HDACi combinations in myelofibrosis.

HDACi
studied
Phas
e
Clinicaltrials.gov
identifier
Populatio
n studied
Efficacy Toxicity Author
and
reference,
if
available
Panobinosta
t (tiw qow
or every
week)
I/II NCT01693601
(PRIME)
PMF or
post-
PV/ET
MF, int-2
or high
risk, in
CP or AP
N/A N/A N/A
Panobinosta
t
I/II NCT01433445 PMF or
post-
PV/ET
MF, int or
high risk,
palpable
spleen ≥ 5
cm below
LCM (N
= 38 in
escalation
phase and
23 in
expansion
phase)
In
expansio
n phase
(n = 23),
57% and
39% had
≥ 35%
SVR at
week 24
and 48;
29% had
≥ 20% ↓
in JAK2
V617F
allele
burden
RP2D: RUX 15
mg bid and PAN
25 mg tiw qow;
21% at RP2D
discontinued due
to AEs; grade
(32%),
3/4 AEs: anemia
(32%),
thrombocytopeni
a (29%), diarrhea
(18%), asthenia
(12%), fatigue
(9%)
Harrison
et al.(94)
Pracinostat
(started
after RUX
alone for
first 3
months;
starting
dose 60 mg
qod × 3
days every
3 weeks)
II NCT02267278 PMF or
post-
PV/ET
MF, int or
high risk,
palpable
spleen ≥ 5
cm below
LCM
N/A N/A N/A

Abbreviations: HDACi, histone deacetylase inhibitor; RUX, ruxolitinib; PMF, primary myelofibrosis; post-PV/ET MF, post-polycythemia vera/essential thrombocythemia myelofibrosis; LCM, left costal margin; N/A, not applicable; CP, chronic phase; AP, accelerated phase; tiw, three times a week; qow, every other week; qod, every other day; int, intermediate; PAN, panobinostat; RP2D, recommended phase 2 dose; bid, twice daily; SVR, spleen volume reduction; JAK2, Janus kinase 2.