NCT05467800 Study of Canakinumab in Patients With Myelofibrosis
| NCT ID | NCT05467800 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | John Mascarenhas |
| Condition | Primary Myelofibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2022-08-02 |
| Primary Completion | 2026-07-31 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
Inclusion Criteria The following are required for inclusion in the study: Parts 1 and 2: 1. Participants must voluntarily sign informed consent form (ICF) and be willing and able to adhere to the study visit schedule and all protocol requirements. 2. Participants must be ≥ 18 years of age at the time of signing the ICF. 3. Participants must have a pathologically confirmed diagnosis of PMF as per the World Health Organization (WHO) diagnostic criteria46 or post-ET MF or post-PV MF according to IWG-MRT criteria.47 4. Participants must have at least one of the following: 1. Hemoglobin \< 10 g/dL 2. Transfusion-dependency (at least 6 units of packed red blood cells (PRBC) in the 12 weeks prior to study enrollment, for a hemoglobin \< 8.5 g/dL, in the absence of bleeding or treatment-induced anemia with the most recent transfusion having occurred in the 28 days prior to study enrollment) 3. Splenomegaly palpated ≥ 5 cm below the left costal margin (LCM) or spleen volume ≥ 450 cc 4. MFSAF v4