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

NCT06664970 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2024-10-30

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-06
Primary Completion
2025-09-30
Completion
2026-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06664970 on ClinicalTrials.gov