Table 1.

Ongoing clinical trials^* of other JAK inhibitors in myelofibrosis

Clinicaltrials.gov number	Drug	Phase	Major inclusion criteria	Comments
NCT02515630	Momelotinib	II	PMF or post-PV/ET MF requiring therapy, int-2 or high risk, or int-1 risk with symptomatic organomegaly, transfusion-dependent, platelets ≥ 50 × 109/L	21-day washout from prior JAK inhibitor; grade ≥ 2 peripheral neuropathy not allowed
NCT02124746	Momelotinib	II	Long-term extension study for patients with PMF, post-PV/ET MF, PV or ET who have tolerated momelotinib and achieved at least stable disease on a previous trial	Patients can receive momelotinib for up to 4 years
NCT01969838 (SIMPLIFY-1)	Momelotinib vs. ruxolitinib	III	PMF or post-PV/ET MF requiring therapy, int-2 or high risk, or int-1 risk with symptomatic organomegaly, anemia (Hgb < 10 g/dL), and/or unresponsive to available therapy; plts ≥ 50 × 109/L, ANC ≥ 0.75 × 109/L, < 10% peripheral blasts	Frontline, head to head study; patients must be JAK inhibitor-naïve; grade ≥ 2 peripheral neuropathy not allowed
NCT02101268 (SIMPLIFY-2)	Momelotinib	III	PMF or post-PV/ET MF, spleen palpable ≥ 5 cm below LCM, int-2 or high risk, or int-1 risk with symptomatic organomegaly, < 10% peripheral blasts, ANC > 0.75 × 109/L, current or prior ruxolitinib required	Comparator is BAT; grade ≥ 2 peripheral neuropathy not allowed; designed for ruxolitinib failures and ruxolitinib-intolerant patients
NCT02564536	Pacritinib (200 mg bid) plus decitabine	0 (pilot)	Intermediate or high risk PMF or post-PV/ET MF who are unresponsive to or unable to receive current therapy, or MDS/MPN patients; ANC ≥ 0.5 × 109/L, < 20% BM blasts	Decitabine administered subcutaneously on days 1, 5, 8, 12, 15, 19, 22, and 26 of a 28-day cycle.
NCT01423851	NS-018	I/II	PMF or post-PV/ET MF requiring therapy; prior JAK2 inhibitor therapy required, R/R or intolerant; ANC > 1 × 109/L, plts > 25 × 109/L	Phase I results published(104)
NCT02055781 (PERSIST-2)(99)	Pacritinib (400 mg daily or 200 mg bid)	III	Intermediate or high risk MF with plts ≤ 100 × 109/L, spleen palpable ≥ 5 cm below LCM, MPN SAF TSS ≥ 13	Comparison arm is BAT; cannot have had > 2 prior JAK2 inhibitors
NCT01773187 (PERSIST-1)(97, 98)	Pacritinib (400 mg daily)	III	Intermediate or high risk MF, spleen palpable ≥ 5 cm below LCM, MPN SAF TSS ≥ 13	Comparison arm is BAT; prior JAK2 inhibitor not allowed

^*Does not include trials involving stem cell transplant.

Abbreviations: MF, myelofibrosis; PMF, primary myelofibrosis; PV, polycythemia vera; ET, essential thrombocythemia; ANC, absolute neutrophil count; plt, platelet; JAK, Janus kinase; MDS, myelodysplastic syndrome; MPN, myeloproliferative neoplasm; bid, twice daily; Hgb, hemoglobin; R/R, relapsed/refractory; BAT, best available therapy; LCM, left costal margin; MPN SAF TSS, myeloproliferative neoplasm symptom assessment form total symptom score. Modified with permission from JNCCN-Journal of the National Comprehensive Cancer Network [136]: Bose P, Verstovsek S. Drug Development Pipeline for Myeloproliferative Neoplasms (MPN): Potential Future Impact on MPN Guidelines and Management. JNCCN 2016. In press.