Study of Canakinumab in Patients With Myelofibrosis

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.

NCT Number	NCT05467800
Lead Sponsor	John Mascarenhas
Conditions	Primary Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, ET-MF, Post-polycythemia Vera Related Myelofibrosis, PV-MF
Enrollment	14 participants
Start Date	2022-08-02
Primary Completion	2026-10-01 (estimated)
Study Completion	2027-07-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-07