Adult Acute Myeloid Leukemia
Conditions
Brief summary
Patients enrolled from each center according to confirmed criteria specified in cooperative scheme are recieved induction and consolidation chemotherapy with microtransplantation . Observe the remission rate and 2-year disease-free survival (DFS) and overall survival(OS) rate.
Detailed description
Microtransplantation, which combines chemotherapy with adoptive infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC). Data from more than 70 elderly AML patients who received microtransplantation in Beijing showed that the remission rate and 2-year disease-free survival (DFS) reach 75-82% and 32-39% respectively, and microchimerisms (donor cells\<1%) were detected without GVHD. The results have been clinically validated in several other centers in China, United States and Australia. In this study, azacytidine, decitabine, BCL / 2 inhibitor and other drugs combined with micro transplantation were used in elderly AML in order to improve the curative effect. Patients enrolled from each center according to confirmed criteria specified in cooperative scheme are recieved induction and consolidation chemotherapy with microtransplantation . Observe the remission rate and 2-year disease-free survival (DFS) and overall survival(OS) rate.
Interventions
HLA-mismatched donor peripheral stem cell infusion
DRUGAzacitidine
azacytidine 50-75mg/m2
DRUGVenetoclax
Venetoclax 100-300mg/d ×3d，400mg 4-28d
Sponsors
guomei
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients must have elderly (60-85 ages) AML pathologically confirmed per WHO guidelines. * Patients have not been treated before. * Patients must have ECOG Performance status of 0,1,or 2. If ECOG 2. * Patients must have a HLA mismatched donor who should be able to provide informed consent. * All genders and races are eligible. * ALT and AST≤3 ×ULN, TBIL≤1.5 × ULN, Cr≤2 ×ULN or CrCl≥40 mL/min * By means of ultrasonic Heartbeat map or multiple gated acquisition (MUGA) scanning determination of LVEF in the normal range. * Donors must be able to safely undergo leukapheresis.
Exclusion criteria
* received operation 4 weeks before randomization * acute promyelocytic leukemia,Myeloid sarcoma, chronic myeloid leukemia in accelerated phase and blastic phase; * active CNS disease, pregnancy, or other major medical or psychiatric illnesses that could compromise tolerance to this protocol * occurred stroke or intracranial hemorrhage within 6 months before randomization. * Require the use of warfarin or equivalent of vitamin K antagonists (such as phenprocoumon) anticoagulant. * There is clinical significance of cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months before randomization, or any heart function grade 3 (moderate) or 4 (severe ) heart disease in accordance with the functional classification method of New York Heart Association (NYHA). * Known to have the following history: human immunodeficiency virus (HIV) or active hepatitis C virus or hepatitis B virus infection * Any situation processed by the PI that will be damaged to the patients safety. * Patients and / or authorized family member refuse to sign the consent. * attend other clinical researchers in 3 months. * Donors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the remission rate | 2month | ①bone marrow: blasts \<5% (with a count of at least 200 Nucleated cells).②Hemogram: absolute neutrophil count of more than 1.0×109/L，platelets of \>100×109/L. ③Clinical: Without the signs and symptoms caused by leukemia infiltration d , and independent of transfusion; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Free Survival | 2 year | Measured from complete remission to the date of death or the date of last follow-up examination; |
| Overall Survival | 2 year | measured from the Date of beginning therapy to the date of death or the date of last follow-up examination; |
Other
| Measure | Time frame | Description |
|---|---|---|
| treatment-related mortality | 2 year | Early mortality: death within 4 weeks after initiation of induction therapy |
Countries
China
Contacts
Primary Contactyajing huang
Backup Contactmei guo
Outcome results
None listed