Microtransplantation Combined With Azacytidine to Improve the Efficacy of EAML

• Status: Recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: guomei
• Treatments: Azacitidine; Venetoclax

Criteria

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 exclusion criteria include:active infection or malignancy, cardiovascular instability, severe anemia, severe coagulation disorder, pregnancy, inadequate venous access, inability to provide consent, or any other condition deemed unsafe by the treatment staff.