NCT06664970

A Multicenter Study on the Treatment of MDS/MPN Overlap Syndrome With AZA or Rux Combined With Selinexor

Prospective, Multicenter Study on the Treatment of Myelodysplastic Neoplasms (MDS)/Myeloproliferative Neoplasms (MPN) Overlap Syndrome With Azacitidine or Ruxolitinib Combined With Selinexor

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multicenter, open label cohort study involving MDS/MPN patients. The enrolled patients have symptoms that require treatment, which are classified according to their clinical conditions as follows: those with MDS as the main manifestation are treated with Azacitidine combined with Selinexor; For those with MPN as the main manifestation, treatment with Selinexor combined with Ruxolitinib is used.

Conditions

• MDS

Interventions

Type	Name	Description
DRUG	Azacitidine or Ruxolitinib combined with Selinexor	1. The initial dose of Selinexor combined with Azacitidine for the treatment of MDS patients is 40mg QW, adjusted according to blood tests, with the highest dose ≤ 60mg QW. Azacitidine: The initial dose is 75 mg/m ², administered subcutaneously or intravenously, with a cycle of 1-7 days and 28 days until ineffective or intolerant. 2. Selinexor combined with Ruxolitinib for the treatment of patients with MPN symptoms: Selinexor dose: 40mg QW; Adjust according to the blood count, with a maximum dose of ≤ 60mg QW. Initial dose of Ruxolitinib: platelet count\>100 × 109/L before enrollment, initial dose is 15 mg BID; Platelets range from 50-100 × 109/L, with an initial dose of 10 mg BID. Until ineffective or intolerant.

Timeline

• Start date: 2024-11-06
• Primary completion: 2025-09-30
• Completion: 2026-09-30
• First posted: 2024-10-30
• Last updated: 2024-10-30

Locations

1 site across 1 country: China