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

Peking Union Medical College Hospital1 site in 1 country39 target enrollmentNovember 6, 2024

ConditionsMDS

InterventionsAzacitidine or Ruxolitinib combined with Selinexor

DrugsAzacitidine or Ruxolitinib combined with Selinexor

Overview

Phase: Phase 2
Intervention: Azacitidine or Ruxolitinib combined with Selinexor
Conditions: MDS
Sponsor: Peking Union Medical College Hospital
Enrollment: 39
Locations: 1
Primary Endpoint: ORR at 6 months of treatment
Status: Enrolling by Invitation
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 6, 2024

End Date

September 30, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peking Union Medical College Hospital

Responsible Party

Principal Investigator

Bing Han

PekingUMCH

Peking Union Medical College Hospital

Eligibility Criteria

Inclusion Criteria

•Meets the diagnostic criteria of MDS/MPN (WHO 2022 edition)
•Age ≥ 18 years old;
•There are indications that require treatment, such as symptomatic anemia, decreased blood cells, splenomegaly, and constitutional symptoms;
•ECOG score 0-2;
•No stem cell transplantation plan within 6 months;
•Liver function: Within 21 days before the start of treatment, total bilirubin\<2 times the upper limit of normal (ULN), alanine aminotransferase (ALT)\<2.5 times ULN;
•Renal function: Within 21 days before the start of treatment, creatinine clearance rate ≥ 30 mL/min, calculated using Cockcroft and Gault formulas;
•Patients receiving erythropoietin therapy or rituximab must be at a stable dosage and have stable transfusion therapy or hemoglobin levels within 8 weeks prior to entering the study.
•Female patients with fertility must agree to the use of dual contraception methods and have a negative serum pregnancy test during screening. Male patients who have sexual intercourse with women with fertility must use effective barrier contraception methods.
•Those who meet the requirements of the ethics committee and sign the informed consent form; Willing and able to comply with clinical visit and research related procedures.

Exclusion Criteria

•Those who have undergone major surgery within 4 weeks before the start of treatment,
•those with severe liver and kidney dysfunction;
•Patients who have undergone splenectomy in the past;
•Patients with unstable cardiovascular function: symptomatic cardiac ischemia, uncontrolled significant conduction abnormalities, congestive heart failure (CHF) with NYHA functional class ≥ 3 or myocardial infarction within 6 months, unstable angina, unstable arrhythmia;
•Uncontrolled active infections require systemic use of antibiotics, antiviral drugs, or antifungal drugs within one week prior to the first administration; Allow the use of prophylactic antibiotics.
•Known active hepatitis A, B, or C infection; Or known to be positive for HCV RNA or HBsAg (HBV surface antigen); Known HIV seropositivity;
•Patients with obvious gastrointestinal lesions or obstruction, or uncontrolled vomiting or diarrhea.
•At baseline, peripheral neuropathy was ≥ grade 2 (within 21 days before the first day of the first cycle).
•History of epileptic seizures, movement disorders, or cerebrovascular accidents (within 1 year before the first day of the first cycle)
•Evidence of AML (≥ 20% of primitive cells in bone marrow or peripheral blood) according to WHO definition