myelodysplastic syndrome (MDS)
Conditions
Interventions
Experimental group:veneclax in combination with demethylating drugs
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with MDS-EB diagnosed by bone marrow cell morphology, immunology and genetics should refer to the World Health Organization diagnostic criteria (WHO 2016 criteria). 2. Aged >= 18 years, no gender limit. 3. If the age is >=75 years old, the Eastern Cooperative Oncology Group (ECOG) physical status score is 0-2 points; 45%. 6. The informed consent form must be signed before all specific research procedures begin, and the informed consent form must be signed by the patient himself. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the legal guardian or the patient's immediate family will sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Has received Bcl-2 inhibitor therapy in the past; 2. Have a history of severe allergy to decitabine and azacitidine; 3. MDS/MPN subjects include chronic myelomonocytic leukemia, atypical chronic myeloid leukemia, juvenile chronic myelomonocytic leukemia and unclassifiable MDS/MPN; 4. Subjects receiving allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 5. If the subject has New York Heart Association (NYHA) class 3 or 4 congestive heart failure, or have a history of NYHA grade 3 or 4 congestive heart failure, unless they have a left ventricular ejection fraction (LVEF) >= 45% in the echocardiographic screening performed within 1 month before entry into the study; 6. Subjects use cytochrome P450 (CYP) 3A strong or moderate inducers within 7 days before starting treatment; 7. Subjects have ingested grapefruit, grapefruit products, limes (including jams containing limes) or star fruit within 3 days before starting study treatment; 8. Positive anti-HIV test; 9. Pregnant or lactating subjects; 10. Mental illness that may prevent the subject from completing the treatment or prevent the subject's informed consent; 11. The subject has evidence of other clinically significant, poorly controlled systemic infections (viral, bacterial or fungal) that require treatment; 12. Poor compliance and other conditions deemed inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Overall response rate;Overall response rate and duration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to acute myeloid leukemia transformation;Event free survival;Overall survival;Disease-free survival;Rate of red blood cell (RBC) transfusion independence;Proportion of platelet transfusion independence;Hematopoietic improvement rate; | — |
Countries
China
Contacts
Public ContactZheng Changcheng
Outcome results
None listed