NCT06770842 Ropeginterferon Alfa 2b Plus Ruxolitinib for Myelofibrosis
| NCT ID | NCT06770842 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The University of Hong Kong |
| Condition | Primary Myelofibrosis (PMF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2026-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
In this open-label single arm phase 2 study, approximately 20 patients with MF demonstrating suboptimal response to ruxolitinib monotherapy will be enrolled. Patients will continue to receive ruxolitinib at a stable dose and ropeginterferon alfa 2b will be added to the regimen.
Eligibility Criteria
Inclusion Criteria: * Willing and able to provide informed consent * Age ≥18 years * Diagnosis of Overt Myelofibrosis (primary, post-ET, or post-PV) per World Health Organization (WHO) 2022 diagnostic criteria * Intermediate-1, Intermediate-2, or high-risk disease by Dynamic International Prognostic Scoring System (DIPSS) * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Platelet count ≥75 x 109/L prior to dosing on Cycle 1 Day 1 * Absolute neutrophil count ≥0.5 x 109/L prior to dosing on Cycle 1 Day 1 * Peripheral blast count ≤10% prior to dosing on Cycle 1 Day 1 * Women of childbearing potential and fertile men must agree to use an approved method of contraception from screening until 30 days after the last dose of ropeginterferon and ruxolitinib. * Patients with suboptimal response to ruxolitinib as per one of the below: i. Relapsed: Ruxolitinib treatment for ≥3 months with spleen regrowth, defined as \<10% SVR or \<30% decrease in spleen size from baseline, fo