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Study of Canakinumab in Patients With Myelofibrosis

NCT05467800 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-05-07

No results posted yet for this study

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

DRUG

Canakinumab

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

Sponsors & Collaborators

  • John Mascarenhas

    lead OTHER

Principal Investigators

  • John Mascarenhas, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-02
Primary Completion
2026-10-01
Completion
2027-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05467800 on ClinicalTrials.gov