Study of Canakinumab in Patients With Myelofibrosis

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Polycythemia
Polycythemia Vera
Post-essential Thrombocythemia Myelofibrosis
Primary Myelofibrosis
Thrombocythemia, Essential
Thrombocytosis

Clinical Trial Details

NCT number	NCT05467800
Study type	Interventional
Source	Icahn School of Medicine at Mount Sinai
Contact	Mikaela Dougherty
Phone	212-241-8839
Email	mikaela.dougherty@mssm.edu
Status	Recruiting
Phase	Phase 2
Start date	August 2, 2022
Completion date	December 2024

View Details

See also
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