A Multicenter Study on the Treatment of MDS/MPN Overlap Syndrome With AZA or Rux Combined With Se… (NCT06664970) | Clinical Trial Compass
By InvitationPhase 2
A Multicenter Study on the Treatment of MDS/MPN Overlap Syndrome With AZA or Rux Combined With Selinexor
China39 participantsStarted 2024-11-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
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).