Efficacy and Safety of Ruxolitinib Combined with Decitabine in Treating High-Risk Myelofibrosis Patients: A Prospective, Multicenter, Phase II Clinical Study Protocol

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600117487

Enrollment

Unknown

Registered

2026-01-26

Start date

2026-01-31

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Myelofibrosis

Interventions

Experimental group:Ruxolitinib combined with decitabine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years, any gender; 2. Diagnosed with PMF, or diagnosed with Post-PV-MF or Post-ET-MF; 3. Assessed as high-risk MF patients; 4. Splenomegaly: palpable spleen edge at or more than 5 cm below the costal margin or spleen volume >=450 cm^3by MRI/CT evaluation; 5. ECOG <=2; 6. Patient has signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who have previously undergone splenectomy; 2. Patients who have previously received allogeneic stem cell transplantation, or who are planning to undergo stem cell transplantation in the near future.

Design outcomes

Primary

Measure	Time frame
The rate of spleen volume response (SVR35) at Week 24, defined as a reduction in spleen volume >= 35% from baseline;	—

Secondary

Measure	Time frame
Myelofibrosis Symptom Assessment Form (MSAF) score;Hematological Improvement (HI);	—

Countries

China

Contacts

Public ContactHuang Jian

The First Affiliated Hospital of Zhejiang University School of Medicine

househuang@zju.edu.cn+86 135 8801 0568

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026