Treatment of patients with higher risk myelodysplastic syndrome
Conditions
Interventions
Single group treatment of high-risk MDS with Selinexor combined with Azacitidine:Single group treatment with Selinexor combined with Azacitidine
Sponsors
Zhenjiang First People's Hospital (Affiliated People’s Hospital of Jiangsu University)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent form in accordance with institutional guidelines. 2. Age = 18 years old. 3. Patients with high-risk myelodysplastic syndrome who are newly diagnosed or have relapsed (including those who have undergone allogeneic stem cell transplantation) and are not suitable for intensive therapy or subjectively do not accept intensive therapy, with IPSS score = 1 or IPSS-R score = 4. If the patient has received allogeneic hematopoietic stem cell transplantation before, it must be more than 100 days after transplantation and have = grade 2 graft-versus-host disease (GVHD). 6. ECOG score is 0-2 points. 7. Liver function is good within the first 21 days of C1D1: total bilirubin<2 times the upper limit of normal (ULN), aspartate aminotransferase (AST)<2.5 times ULN, alanine aminotransferase (ALT)<2.5 × ULN. 8. Good renal function within 21 days before C1D1: creatinine clearance rate = 30 mL/min. 9. If all the inclusion criteria above are met, there is no limit to the number of lines previously treated by the patient.
Exclusion criteria
Exclusion criteria: 1. Pregnant women or breastfeeding patients who have the intention to conceive during the treatment period; 2. Patients who have received chemotherapy, immunotherapy, or other anti-cancer treatments within = 3 weeks prior to enrollment; 3. Patients who have undergone major surgery within the four weeks prior to enrollment; 4. Patients with unstable cardiovascular function (including symptomatic ischemia, uncontrolled clinically significant conduction abnormalities, NYHA = 3 congestive heart failure, history of myocardial infarction (MI) within 3 months, etc.); 5. Patients who experience uncontrollable active infections within one week prior to the first administration and require systemic antibiotics, antiviral drugs, or antifungal drugs for treatment (prophylactic antibiotics are allowed); 6. Patients known to be HIV seropositive; 7. Known active hepatitis A, B, or C infections; 1.Or known HCV RNA or HBsAg (HBV surface antigen) positive patients; 8. Patients with another type of active tumor; 9. Patients with serious illnesses, gastrointestinal obstruction, uncontrolled vomiting or diarrhea; 10. Patients with peripheral neuropathy grade = 2 at baseline; 11. Patients with a history of epilepsy, motor disorders, or cerebrovascular accidents within the year prior to enrollment; 12. Patients with macular degeneration leading to significant visual impairment or uncontrolled glaucoma; 13. Patients who are significantly below their ideal weight (BMI<17); 14. Patients with severe mental or medical conditions that may interfere with treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate after six cycles of combination therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the patient's adverse reactions and safety, as well as the duration of grade 3-4 blood cell reduction;Determine the time and duration of the first treatment response in MDS patients;Evaluate patient survival time: Event free survival (EFS, including any cause of death, recurrence, progression), overall survival (OS); | — |
Countries
China
Contacts
Public ContactJun Qian
Zhenjiang First People's Hospital (Affiliated People’s Hospital of Jiangsu University)
Outcome results
None listed