Study of Canakinumab in Patients With Myelofibrosis
Status:
Recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
Summary
This is an open label, multicenter, phase 2 trial of Canakinumab in patients with primary
myelofibrosis (PMF), post essential thrombocythemia/polycythemia vera related MF (Post ET/PV
MF). Eligible patients will receive Canakinumab administered as a subcutaneous injection on
day 1 of a 21 day cycle for a core study period of 8 cycles. Canakinumab will be given by
subcutaneous injection (SC) injection at a starting dose of 200 mg (one 150 mg/mL syringe and
one 50 mg/0.5 mL syringe) every 3 weeks. The interim analysis will be performed when the
number of enrolled patients reaches 10. If no responses OR 4 or more patients have
unacceptable toxicity, the study will not proceed to the second stage. If the total number of
patients reaches the maximum sample size of 26, the treatment is deemed acceptable if the
number of responses in the efficacy endpoint are greater than 3, and the number of toxicities
are less than 7.