Myelodysplastic Neoplasms
Conditions
Interventions
Lisa-Dec group:Lisaftoclax 600mg/d qd oral, days 1-7
Decitabine 20mg/m^2/d subcutaneous injection, days 1-3
one cycle every 28 days, total 4 cycles. If combined with CYP3A inhibitors or P-gp inhibitors, reduce Lisaftoclax dose accordingly (to 200mg for strong CYP3A inhibitors, to 400mg for moderate CYP3A in
Sponsors
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects eligible for enrollment in this study must meet all of the following criteria: 1. Age > 18 years; 2. MDS diagnosed according to the WHO 2022 criteria, with IPSS score > 3.5 (see Appendix A); 3. ECOG performance status score = 10 g/dL, platelets >= 100×10^9/L; neutrophils >= 1.0×10^9/L; blasts 0%. (2) Disease progression (PD): during or after treatment with venetoclax combined with hypomethylating agents, disease progression (PD) is defined as meeting any of the following criteria: 1. Blast progression: compared with the baseline sample obtained before the start of the current treatment line, a relative increase in blasts >= 50%, with an absolute increase in blast percentage of at least 5%. 2. Worsening progression of cytopenia: in the absence of hematologic improvement (HI) in at least one other hematopoietic lineage, new and recurrent (more than once and at an interval of >= 7 days) red blood cell or platelet transfusion requirements occur within 8 weeks, and such requirements are unrelated to acute comorbid conditions (such as sepsis or gastrointestinal bleeding) or treatment effects. 3. Progression to acute myeloid leukemia (AML): compared with baseline assessment, blasts increase by >= 50% and reach >= 20% blasts. (3) Intolerance/toxicity-related discontinuation: inability to continue treatment due to adverse reactions to venetoclax. (4) Relapsed patients: patients who achieved complete remission (CR) during or after treatment with venetoclax combined with hypomethylating agents, but subsequently developed disease relapse, defined as a return of the bone marrow blast percentage to the pretreatment level, or the occurrence of new dysplasia/cytopenia, meeting at least one of the following: 1. Bone marrow blast percentage returns to the pretreatment level (or >= 5%). 2. New dysplasia or cytopenia occurs (meeting the diagnostic criteria for MDS). 3. New cytogenetic abnormalities occur. 5) Expected survival >= 3 months; 6) Major organ function meets the following criteria: (1) ANC >= 0.5×10^9/L, PLT >= 20×10^9/L (transfusion support is allowed) (2) TBIL = 50 ml/min 7. Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1.Transformed to acute myeloid leukemia (bone marrow blasts >= 20%); 2.Uncontrolled active infection requiring intravenous antibiotic therapy. 3.Severe hepatic or renal dysfunction (Child-Pugh class C or creatinine clearance [CrCl] = 5 years. 7.Pregnant or breastfeeding women. 8.Any other condition that, in the investigator’s judgment, makes the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessment;Median progression-free survival (PFS;24Monthly survival rate;Overall survival (OS; | — |
Countries
China
Contacts
Public ContactLi Bing
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.
Outcome results
None listed