Table 4.
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.