Myelodysplastic syndrome/acute myeloid leukemia
Conditions
Interventions
Experimental group:Venetoclax Combined Descitabine Preconditioning Regimen
Sponsors
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Primary hematologic disease was high-risk myelodysplastic syndrome or acute myeloid leukemia, with allogeneic HSCT indications; 2.High-risk MDS/AML includes the following conditions: (1)Compliance with the 2017 WHO classification MDS diagnostic criteria and has one of the following features: 1)Compliance with MDS-EB2 diagnosis; 2)With poor prognosis chromosomal karyotype; 3)IPSS-R score is extremely high risk; 4)Positive TP53 mutation in the first diagnosis. (2)High-risk AML includes relapsed-refractory AML and pretransplant MRD-positive AML: 1)Refractory AML: A)Invalidated after 2 courses of standard chemotherapy; B)Underwent Consolidation chemotherapy after CR but relapsed within 12 months; C)Relapsed after 12 months but routine chemotherapy was invalid; D)Two or more relapses; E)Extramedullary leukemia have been existed. 2)Relapse AML: leukemic cells or bone marrow primary cells > 0.050 in peripheral blood after complete remission (CR) (except for other reasons such as myeloreconstitution after consolidation chemotherapy) or ultramedullary leukemia cell infiltration; 3)A positive MRD before transplantation meets one of the following conditions: A)Abnormal myeloid cells > 0.01% in flow detection before transplantation; B)Positive molecular biology detection before transplantation; 3.Age >= 50 years old, gender, racial unlimited; 4.ECOG score <= 2; 5.Patient himself or his authorized client agreed to participate in the clinical trial and sign an informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with other malignant tumors require treatment; 2.Patients with active infections, such as hepatitis B, hepatitis C, tuberculosis, etc.; 3.Patients with positive HIV serological reaction; 4.Patients with one or more major organ dysfunction, such as heart, lung, liver, kidney, and so on, unable to tolerate treatment; 5.Patients with clinical symptoms of brain dysfunction or serious mental disorders or other conditions that cannot be understood or comply with treatment and monitoring requirements; 6.Allergic to any pretreatment drugs including venetoclax, dexitabine, paracetamol, or any component; 7.Researchers judge that the patients are not fit to join the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year Relapse-free Survival Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival rate;Recurrence rate;Transplantation related mortality rate;Incidence of graft versus host disease;Hematopoietic reconstruction; | — |
Countries
China
Contacts
Public ContactJiang Erlie
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed