Microtransplantation Combined With Azacytidine to Improve the Efficacy of EAML

  • STATUS
    Recruiting
  • End date
    Jul 1, 2025
  • participants needed
    300
  • sponsor
    guomei
Updated on 13 March 2022

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.

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.

Details
Condition Adult Acute Myeloid Leukemia
Treatment Azacitidine, venetoclax, microtransplantation, HLA-mismatched donor peripheral stem cell infusion
Clinical Study IdentifierNCT05262465
Sponsorguomei
Last Modified on13 March 2022

Eligibility

Yes No Not Sure

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
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