NCT05467800

Study of Canakinumab in Patients With Myelofibrosis

A Phase 2 Study of Canakinumab in Patients With Myelofibrosis Myeloproliferative Neoplasms Research Consortium [MPN-RC 122]

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: John Mascarenhas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Myelofibrosis
• Post-essential Thrombocythemia Myelofibrosis
• ET-MF
• Post-polycythemia Vera Related Myelofibrosis
• PV-MF

Interventions

Type	Name	Description
DRUG	Canakinumab	Canakinumab administered as a subcutaneous injection on day 1 of a 21 day cycle for a core study period of 8 cycles.

Timeline

• Start date: 2022-08-02
• Primary completion: 2026-07-31
• Completion: 2027-07-01
• First posted: 2022-07-21
• Last updated: 2026-03-19

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study