Myelodysplastic syndrome (MDS)/chronic monocytic leukemia (CMML)/acute myeloid leukemia (AML)
Conditions
Interventions
Combined treatment group:Venetoclax and Azacitidine Combination
Monotherapy group:Azacitidine
Sponsors
Blood Diseases Hospital, Institute of Hematology, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The high-risk MDS has one of the following characteristics: (1) High-risk chromosome karyotypes (poor and extremely poor IPSS-R); (2) Bone marrow primitive cells > 10%; (3) TP53 mutation was positive. 2. AML patients with high recurrence risk, including refractory and MRD-positive AML patients before transplantation, meet one of the following conditions: (1) Refractory AML meets one of the following conditions: 1) Initial treatment cases that failed after 2 courses of standard chemotherapy; 2) After CR consolidation and intensive therapy, relapse occurred within 12 months; 3) Relapse after 12 months, but conventional chemotherapy failed; 4) Two or more relapses; 5) Extramedullary leukemia persists. (2) Recurrent AML, i.e. the recurrence of peripheral blood leukemia cells or bone marrow primitive cells >0.050 after complete response (except for other causes such as bone marrow reconstruction after consolidation chemotherapy) or the occurrence of extramedullary leukemia cell infiltration. (3) If MRD is positive before transplantation, one of the following conditions can be met. 1) The proportion of abnormal myeloid cells detected by flow cytometry before transplantation was >0.01%; 2) Positive detection of molecular biology before transplantation. (4) AML with poor prognosis (according to Chinese Guidelines for the Diagnosis and Treatment of Adult acute myeloid leukemia (non-acute promyelocytic leukemia), 2021 edition). 3. In line with WHO classification criteria for CMML diagnosis. 4. MDS or CMML transformed AML.
Exclusion criteria
Exclusion criteria: 1. Patients who relapsed within 3 months after transplantation or during maintenance therapy, including hematologic, molecular, cytogenetic, and extramedullary relapses; 2. Known serologic responses of HIV or active hepatitis B virus (HBV) and hepatitis C virus (HCV) are positive; 3. Suffers from a mental disorder or other medical condition and is unable to comply with the requirements of research treatment and monitoring; 4. Pregnant patients or patients unable to take appropriate contraceptive measures during treatment; 5. Suspected allergic to the test drug or any excipients thereof; 6. Active heart disease, defined as one or more of the following: (1) A history of uncontrolled or symptomatic angina; (2) Myocardial infarction less than 6 months after enrollment; (3) A history of arrhythmia requiring drug therapy or severe clinical symptoms; (4) Uncontrolled or symptomatic congestive heart failure (> NYHA grade 2); (5) The ejection fraction was lower than the lower limit of the normal range; 7. Those who were considered unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cytogenetic/ Molecular relapse; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematologic relapse;Overall survival;Transplant-related mortality;Graft-versus-host disease;Patient's tolerance; | — |
Countries
China
Contacts
Public ContactJiang Erlie
Blood Diseases Hospital, Institute of Hematology, Chinese Academy of Medical Sciences
Outcome results
None listed