Canakinumab for Myelofibrosis

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: John Mascarenhas

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults diagnosed with primary myelofibrosis or related conditions, who cannot take ruxolitinib/fedratinib due to low platelet counts or lack of response. They must have adequate organ function, not be eligible for certain other treatments, and agree to use contraception. Excluded are those with unstable heart disease, recent live vaccinations, high-dose steroid treatment within 14 days, active infections including HIV and hepatitis B/C, or any serious medical/psychiatric issues.

Inclusion Criteria

I have been diagnosed with primary myelofibrosis or its advanced stages after ET/PV.

I have low hemoglobin, need regular blood transfusions, have an enlarged spleen, or a high MF-SAF score.

I agree to sign the consent form and follow the study's schedule and rules.

+10 more

Exclusion Criteria

I have had cancer before, but it was either cured locally or has been inactive for over a year.

I have had a bone marrow or organ transplant before.

I have a known heart condition.

+9 more

Participant Groups

The trial is testing Canakinumab given as a subcutaneous injection every three weeks over eight cycles in patients with myelofibrosis. The study will assess the drug's effectiveness and safety through an interim analysis after ten patients are enrolled and may stop if there's excessive toxicity or no responses.

1Treatment groups

Experimental Treatment

Group I: CanakinumabExperimental Treatment1 Intervention

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.

Canakinumab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Ilaris for: