Higher-risk myelodysplastic syndrome
Conditions
Interventions
Trial group:Decitabine (DEC): 3-day regimen: 20 mg/(m2 per dose), administered by intravenous infusion once daily for 3 consecutive days
Venetoclax (VEN): 400 mg per dose, taken orally once daily for 7 consecutive days, with one treatment cycle approximately every 28 days.
If the subject experiences significant toxicity, dosing shou
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: 1. The Diagnosis of MDS was based on the minimum diagnostic criteria of MDS and classified according to the WHO (2022) classification standards after undergoing blood cell count, bone marrow examination, cytogenetic examination and molecular genetic examination within 30 days prior to enrollment; 2. MDS with bone marrow blasts >=5%; 3.According to the prognosis score of IPSS-R >3.5 points; 4.Patients aged 18 years or older (including 18 years); 5.Subjects have an Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2 at screening; 6.Sound hepatic and renal function (creatinine <=1.5 mg/dL, BUN <=1.5 mg/dL, ALT <=2×ULN,AST <=2×ULN,TB <=2×ULN); 7.Females of childbearing age are required to undergo a pregnancy test before receiving treatment. During treatment and within 3 months of the last dose, males and females of childbearing age must agree to use effective contraception; 8.Subjects must sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients aged = 20%; 10. Those with known hypersensitivity to any of the components of Decitabine and Venetoclax; 11.Those have received treatment with Azacitidine, Decitabine, Venetoclax or other chemotherapeutic agents, or have undergone hematopoietic stem cell transplantation within the past year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response(CR)/equivalent complete response(CR equivalent);Partial remission(PR);CR with limited count recovery(CRL);Hematologic improvement(HI);CR with partial hematologic recovery(CRh); | — |
Secondary
| Measure | Time frame |
|---|---|
| Cytogenetic response (including complete cytogenetic response and partial cytogenetic response);Minimal residual disease (MRD) status assessed by next-generation sequencing (NGS);Patient-reported outcomes (PROs);Time to response (TTR);Duration of response (DOR);Time to transformation to acute myeloid leukemia (AML);Hematopoietic stem cell transplantation (HSCT) rate;Overall survival (OS);Event-free survival (EFS);Progression-free survival (PFS); | — |
Countries
China
Contacts
Public ContactXiao Zhijian
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.
Outcome results
None listed